Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Hong Kong and Taiwan
Phase: NA
Conditions: Advanced Heart Failure
Sponsor: Abbott Medical Devices

ABT-CIP-10382 Ver. A  
Study Name: Hong Kong and Taiwan HM3 PMS 
Post Market Surveillance Plan  
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used 
without the express written consent of Abbott 
Template: 86357 Rev. H 
 
Page 1 of 57 
 
 
ABT-CIP-10382 
CRD 1022 
 
Hong Kong and Taiwan HM3 PMS 
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Hong Kong and 
Taiwan 
 
 
Version Number 
A 
Date 
December 2, 2020 
Device and Model 
HeartMate 3 
106524INT 
Planned Number of Sites and 
Region(s) 
4, Hong Kong and Taiwan 
Abbott Medical Expert 
Robert Kormos, MD 
6300 Bee Cave Rd Building 2, suite 100 
Austin, TX – 78746 
Ph: 5122864310 
Email: Robert.Kormos@abbott.com 
Sponsor 
Abbott – Heart Failure 
168 Middlesex Turnpike 
Burlington, MA 01803 
USA  
Electronic Data Capture Software 
Oracle Clinical 
PMS plan Author of Current Version  
Carlo Gazzola, BSc 
 
 
 
 

ABT-CIP-10382 Ver. A  
Study Name: Hong Kong and Taiwan HM3 PMS 
Post Market Surveillance Plan  
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used 
without the express written consent of Abbott 
Template: 86357 Rev. H 
 
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SITE PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
 
I have read and agree to adhere to the post market surveillance plan and all regulatory 
requirements applicable in conducting this post market surveillance. 
 
 
Site Principal Investigator 
 
Printed name: 
Signature: 
Date: 
 
 
 

ABT-CIP-10382 Ver. A  
Study Name: Hong Kong and Taiwan HM3 PMS 
Post Market Surveillance Plan  
 
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without the express written consent of Abbott 
Template: 86357 Rev. H 
 
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TABLE OF CONTENTS 
1.0 
INTRODUCTION ................................................................................................... 8 
 
Background and Rationale ............................................................................................ 8 
 
Background .............................................................................................................. 8 
 
Rationale for Conducting this Post Market Surveillance Study .................................. 9 
2.0 
POST MARKET SURVEILLANCE OVERVIEW .................................................... 9 
 
Objective ....................................................................................................................... 9 
 
Device(s) Used in the Post Market Surveillance .......................................................... 10 
 
Indication for Use ....................................................................................................10 
 
Description of the Device(s) Under Investigation .....................................................10 
3.0 
POST MARKET SURVEILLANCE DESIGN ........................................................ 11 
 
Procedures and Follow-up Schedule .......................................................................... 11 
 
Measures Taken to Avoid and Minimize Bias .............................................................. 13 
 
Suspension or Early Termination of the Post Market Surveillance .............................. 13 
4.0 
POST MARKET SURVEILLANCE OUTCOMES ................................................. 13 
5.0 
SUBJECT SELECTION AND WITHDRAWAL ..................................................... 14 
 
Subject Population ...................................................................................................... 14 
 
Subject Recruitment/Screening and Informed Consent ............................................... 14 
 
Subject Recruitment and Screening ........................................................................14 
 
Informed Consent ....................................................................................................14 
 
Eligibility Criteria ......................................................................................................... 15 
 
Subject Enrollment ...................................................................................................... 15 
 
Subject Withdrawal and Discontinuation ..................................................................... 15 
 
Number of Subjects .................................................................................................... 16 
 
Total Expected Duration of the Post market surveillance ............................................ 16 
6.0 
TREATMENT AND EVALUATION OF ENDPOINTS........................................... 17 
 
Baseline/Enrollment .................................................................................................... 17 
 
Implant ........................................................................................................................ 18 
 
Follow-Up Visit Assessments ...................................................................................... 19 
 
Unscheduled Visits ..................................................................................................... 20 
 
Adverse Events .......................................................................................................20 
 
Reoperations ...........................................................................................................20 

ABT-CIP-10382 Ver. A  
Study Name: Hong Kong and Taiwan HM3 PMS 
Post Market Surveillance Plan  
 
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without the express written consent of Abbott 
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Rehospitalizations ...................................................................................................20 
 
Subject Outcomes....................................................................................................... 20 
 
Schedule of Events ..................................................................................................... 20 
7.0 
Adverse Events ................................................................................................... 22 
 
Definition ..................................................................................................................... 22 
 
Adverse Event .........................................................................................................22 
 
Serious Adverse Event ............................................................................................22 
 
Device Deficiency ....................................................................................................23 
 
Device Relationship .................................................................................................... 23 
 
Adverse Event and Device Deficiency Reporting ........................................................ 23 
 
Adverse Event Reporting .........................................................................................23 
 
Device Deficiency Reporting....................................................................................24 
 
Adverse Event and Device Deficiency Reporting to Country Regulatory Authorities 
by the Sponsor ......................................................................................................................25 
8.0 
STATISTICAL CONSIDERATIONS..................................................................... 25 
 
Analysis Populations ................................................................................................... 25 
 
Statistical Analyses ..................................................................................................... 25 
 
Primary Efficacy Endpoint .......................................................................................25 
 
Primary Safety Endpoint ..........................................................................................25 
 
Secondary Efficacy and Safety Endpoints ...............................................................25 
 
Sample Size Calculation ............................................................................................. 26 
 
Timing of Analysis ....................................................................................................... 27 
 
Subgroup Analysis ...................................................................................................... 27 
 
Procedures for Accounting for Missing Data ............................................................... 27 
 
Planned Interim Analysis............................................................................................. 27 
 
Deviations from Statistical Plan ................................................................................... 27 
9.0 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS ....................................... 27 
10.0 QUALITY CONTROL AND QUALITY ASSURANCE........................................... 27 
 
Selection of Clinical Sites and Investigators ................................................................ 27 
 
PMS plan Amendments .............................................................................................. 27 
 
Training ....................................................................................................................... 28 
 
Monitoring ................................................................................................................... 28 

ABT-CIP-10382 Ver. A  
Study Name: Hong Kong and Taiwan HM3 PMS 
Post Market Surveillance Plan  
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used 
without the express written consent of Abbott 
Template: 86357 Rev. H 
 
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Deviations from PMS plan ........................................................................................... 29 
 
Quality Assurance Audit .............................................................................................. 29 
11.0 DATA HANDLING AND RECORD KEEPING ..................................................... 29 
 
Protection of Personally Identifiable Information ......................................................... 30 
 
Data Management Plan .............................................................................................. 30 
 
Source Documentation ............................................................................................... 31 
 
Case Report Form Completion.................................................................................... 31 
 
Record Retention ........................................................................................................ 31 
12.0 ETHICAL CONSIDERATION .............................................................................. 32 
 
Institutional Review Board Approval ............................................................................ 32 
13.0 POST MARKET SURVEILLANCE CONCLUSION .............................................. 32 
14.0 PUBLICATION POLICY ...................................................................................... 32 
15.0 RISK ANALYSIS ................................................................................................. 33 
 
Anticipated Clinical Benefits ........................................................................................ 33 
 
Foreseeable Adverse Events and Anticipated Adverse Device Effects ....................... 33 
 
Residual Risks Associated with the Device Under Investigation, as Identified in the 
Risk Management Report / Risk Analysis Report................................................................... 33 
 
Risks Associated with Participation in this Post Market Surveillance ........................... 33 
 
Steps Taken to Control or Mitigate Risks .................................................................... 34 
 
Risk to Benefit Rationale ............................................................................................. 35 
APPENDIX I: ABBREVIATIONS AND ACRONYMS ..................................................... 36 
APPENDIX II: DEFINITIONS ........................................................................................ 38 
APPENDIX III: CONTACT INFORMATION ................................................................... 49 
APPENDIX IV: ANTICIPATED ADVERSE EVENTS ..................................................... 50 
APPENDIX V: CASE REPORT FORMS ....................................................................... 52 
APPENDIX VI: INFORMED CONSENT FORM ............................................................. 53 
APPENDIX VII: MONITORING PLAN ........................................................................... 54 
APPENDIX VIII: REVISION HISTORY .......................................................................... 55 
APPENDIX IX: PMS PLAN SUMMARY ........................................................................ 56 
APPENDIX X: REFERENCES ...................................................................................... 57 
 
 

ABT-CIP-10382 Ver. A  
Study Name: Hong Kong and Taiwan HM3 PMS 
Post Market Surveillance Plan  
 
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without the express written consent of Abbott 
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TABLE OF FIGURES 
 
Figure 1. The HM3 Left Ventricular Assist System. It comprises of the LVAD (A) with an inflow 
cannula, outflow graft, modular driveline cable, power source (i.e. batteries or power module 
that connects to an AC outlet), and a system controller (B). ......................................................10 
Figure 2: Post Market Surveillance Flowchart...........................................................................12 
 
 
TABLE OF TABLES  
 
Table 1: Pre-implant Baseline Assessments .............................................................................17 
Table 2. Data to be collected at the time of HM3 implant. .........................................................18 
Table 3. Follow-up visit assessments. ......................................................................................19 
Table 4. Follow-up visit windows...............................................................................................20 
Table 5. Schedule of assessments. ..........................................................................................21 
 
 
 

ABT-CIP-10382 Ver. A  
Study Name: Hong Kong and Taiwan HM3 PMS 
Post Market Surveillance Plan  
 
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without the express written consent of Abbott 
Template: 86357 Rev. H 
 
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COMPLIANCE STATEMENT:  
 
This study will be conducted in accordance with this Post Market Surveillance plan, the 
Declaration of Helsinki, ISO 14155:2011 standard and the appropriate local legislation(s). The 
most stringent requirements, guidelines or regulations must always be followed. The conduct of 
the post market surveillance will be approved by the appropriate Institutional Review Board 
(IRB) of the respective clinical site and as specified by local regulations. 
 
 
 

ABT-CIP-10382 Ver. A  
Study Name: Hong Kong and Taiwan HM3 PMS 
Post Market Surveillance Plan  
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used 
without the express written consent of Abbott 
Template: 86357 Rev. H 
 
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1.0 
INTRODUCTION 
The purpose of this post-market surveillance (PMS) is to collect data on clinical and functional 
outcomes with the HeartMate 3™ (HM3) left ventricular assist system (LVAS) as a treatment for 
advanced heart failure, refractory to optimal medical management in Hong Kong and Taiwan. 
The PMS is being sponsored by Abbott – the manufacturer of the HM3 LVAS.  
This PMS will be conducted in accordance with this PMS plan. All investigators involved in the 
conduct of the study will be qualified by education, training, or experience to perform their tasks 
and this training will be documented appropriately. 
 
Background and Rationale 
 Background 
Patients with heart failure suffer significant morbidity and mortality. Heart Failure results when 
the pumping efficiency of the heart is diminished to the point of lack of end-organ perfusion. 
Since, allogenic heart transplantation is limited by insufficient supply of donor organs, left 
ventricular assist devices (LVADs) have become a mainstay of advanced heart failure treatment 
for patients on the waiting list and those not eligible for transplantation.  
 
The HM3 is a durable, centrifugal-flow pump that has shown to improve the clinical and 
functional outcomes of advanced heart failure patients.1 The pump is approved in multiple 
geographies for both short- and long-term left ventricular support for New York Heart 
Association (NYHA) class IIIB/IV heart failure patients.2,3 Hemocompatibility related adverse 
events have been one of the main reasons for the slow adoption of LVADs for the treatment of 
heart failure, in spite of the improvements seen in quality-of-life (QoL) and functional outcomes. 
The HM3 was designed to have an improved hemocompatibility profile, with a frictionless fully 
magnetically levitated rotor, wider blood flow passages, and a programmed intrinsic pulse to 
reduce stasis.4  
 
The CE Mark trial (clinicaltrials.gov identifier: NCT02170363) for the HM3 LVAD was a 
prospective, multicenter, single arm trial that enrolled 50 subjects at 10 sites. This was the first 
clinical investigation of the HM3 left ventricular assist system (LVAS). Six-month outcomes from 
this trial demonstrated 92% (95% confidence interval 83-97%) survival and led to the CE Mark 
approval of the HM3. Analysis of longer term data demonstrated a 2-year survival of 74 ± 6%.5,6 
At 2-years, QoL and functional outcomes remained significantly improved relative to baseline: 
the mean EQ-5D QoL scored improved from 48.2 to 70.6; 82% of the subjects were in NYHA 
class I/II compared to 32% at baseline; the mean 6-minute walk distance increased from 239 to 
347 m. No instances of device thrombosis were observed in this cohort at 2 years.6 Subjects will 
be followed for 5 years as a condition of CE Mark approval.  
 
After CE Mark approval, the ELEVATE (Evaluating the HeartMate 3 with Full MagLev 
Technology in a Post-Market Approval Setting; clinicaltrials.gov identifier: NCT02497950) 
registry was initiated to collect real-world data on consecutive HM3 patients at 26 centers in 
Europe, Israel, Singapore, and Kazakhstan. The study enrolled 463 primary implant patients, 19 
pump exchange patients, and collected only outcome data on an additional 58 patients who  

ABT-CIP-10382 Ver. A  
Study Name: Hong Kong and Taiwan HM3 PMS 
Post Market Surveillance Plan  
 
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without the express written consent of Abbott 
Template: 86357 Rev. H 
 
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were unable to provide consent due to a study outcome (n=57 death, n=1 explant). The 
ELEVATE trial reported, for the primary implant cohort at 2-years, actuarial survival of 83.4%, 
and adverse events of stroke in 10%, suspected pump thrombosis in 1.5%, and bleeding in 
34%. Mean EQ-5D score increased from 35 to 67 and 6MWT distance improved from 104 to 
350 m.7 Subjects will be followed until the last patient completes the 5 year follow-up or 
experiences an outcome.  
 
The MOMENTUM 3 study (Multi-center Study of MagLev Technology in Patients Undergoing 
MCS Therapy with HeartMate 3: clinicaltrials.gov identifier: NCT02224755) was a prospective, 
randomized, multicenter, non-blinded, clinical trial that enrolled 1,028 patients at 69 sites in the 
US. The study randomized patients to receive either the HM3 or HMII LVAD. The study design 
incorporated an initial safety phase that evaluated 30 subjects at 5 sites prior to study 
expansion.8 The primary objective of the trial was to evaluate the safety and efficacy of using 
the HM3 LVAD in indicated patients at two timepoints: 6 months (short-term n=294) and 2 years 
(long-term n=366). The primary endpoint was a composite of survival free of disabling stroke or 
survival free of reoperation to replace or remove the device (for reasons other than recovery).9 
The secondary endpoint, which the study was powered to assess, was freedom from pump 
exchange through 2-years of follow-up in the full cohort of 1,028 patients. All study endpoints 
were successfully met.9-11 The MOMENTUM 3 trial reported the full cohort HM3 actuarial 
survival at 2-years as 79.0% and stroke rates of 9.9%, suspected pump thrombosis rates of 
1.4%, and bleeding rates of 43.7%.11 Mean EQ-5D-5L score improved from 50 to 76. 
Performance on the 6-minute walk test improved from 136 to 323 m, and 80% of the subjects 
were determined to be NYHA class I or II relative to 0% at baseline.  
 Rationale for Conducting this Post Market Surveillance Study 
The objective of this PMS is to assess clinical and functional outcomes under Hong Kong and 
Taiwanese standard of care for advanced heart failure patients implanted with the HM3 LVAS. 
PMS participants will be followed until the 24 months follow-up visit or until they experience an 
outcome, whichever comes first. 
2.0 
POST MARKET SURVEILLANCE OVERVIEW 
 
Objective 
The primary objective of this prospective, post-market surveillance study is to evaluate the 
functional and clinical outcomes with the HM3 LVAS, in the setting of Hong Kong and 
Taiwanese standard of care of advanced heart failure patients implanted with this device.  
Secondary objective of this PMS is to assess the adverse events occurring during the 
surveillance period.   
Assessments will include: 6-minute walk test (6MWT), NYHA heart failure severity classification, 
rates of survival, transplant, pump exchange or explant, device malfunctions, reoperations, 
rehospitalizations and the incidence of adverse events including, but not limited to, neurological 
dysfunction, bleeding, infections and device thrombosis. The definitions for the adverse events 
are in Appendix II and are INTERMACS definitions as used in the MOMENTUM3 study.  

ABT-CIP-10382 Ver. A  
Study Name: Hong Kong and Taiwan HM3 PMS 
Post Market Surveillance Plan  
 
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without the express written consent of Abbott 
Template: 86357 Rev. H 
 
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Device(s) Used in the Post Market Surveillance 
This PMS will be assessing functional and clinical outcomes with the HM3 as a treatment for 
advanced heart failure in the setting of Hong Kong and Taiwan standard-of-care.  
 
Figure 1. The HM3 Left Ventricular Assist System. It comprises of the LVAD (A) with an inflow 
cannula, outflow graft, modular driveline cable, power source (i.e. batteries or power module 
that connects to an AC outlet), and a system controller (B).  
 
 
 Indication for Use 
Please refer to the country specific IFU for the local indications for use.  The HeartMate 3 Left 
Ventricular Assist System is indicated for providing short- and long-term mechanical circulatory 
support (e.g. as bridge to transplant or myocardial recovery, or destination therapy) in patients 
with advanced refractory left ventricular heart failure. 
 Description of the Device(s) Under Investigation 
The HM3 LVAS consists of a centrifugal left ventricular assist device (LVAD) with an outflow 
graft and modular driveline cable, a pump controller and a power source (i.e. portable Batteries, 
Power Module, or Mobile Power Unit). The HM3 LVAD is comprised of an Inflow Cannula, a 
Pump Cover, a Lower Housing, a Screw Ring to attach the Pump Cover to the Lower Housing, 
a Motor, the Outflow Graft, and a Pump Cable.  
 
The HM3 LVAD has a displacement volume of 80 milliliters and weighs 200 grams. All blood 
contacting surfaces are composed of titanium (LVAD body and centrifugal rotor) or gelatin-
impregnated woven polyester (outflow graft). The HM3 LVAD is designed to reduce adverse 
events associated with LVAD thrombosis. Primary design features include full magnetic 

ABT-CIP-10382 Ver. A  
Study Name: Hong Kong and Taiwan HM3 PMS 
Post Market Surveillance Plan  
 
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levitation and large flow gaps, which minimize the shear stress imparted onto the blood 
elements. 
 
The HM3 Controller is an extracorporeal interface device that receives power from the Power 
Module, Mobile Power Unit, or portable Batteries, and appropriately delivers that power to the 
HM3 LVAD. It is the primary user interface and has several important functions including: 
• 
operating condition display, 
• 
source of audible and visible alarms, 
• 
communication link for transferring event/period log and alarm information, and 
• 
battery backup in the case of full power disconnection. 
 
The HM3 LVAD and Controller are sterilized using 100% ethylene oxide. Please refer to each 
device’s respective local IFU for additional information regarding the device used in this PMS 
study. Modifications made to the device or manufacturing practices in response to issues 
identified during the MOMENTUM 3 IDE study are described in Appendix IV. 
3.0 
POST MARKET SURVEILLANCE DESIGN 
This prospective, single arm, post market surveillance is designed to evaluate clinical and 
functional outcomes with the HM3 LVAS as a treatment for advanced heart failure. The PMS will 
enroll approximately 30 patients, that meet the HM3 commercially approved labelling 
indications, from approximately 4 sites in Hong Kong and Taiwan. 
 
Procedures and Follow-up Schedule 
The PMS Design and follow-up requirements of this post market surveillance study are 
described below. Follow-up visits will occur at Baseline/Enrollment, HM3 Implant, 1, 3, 6, 12 and 
24 months unless the subject experiences an outcome. All visits are relative to HM3 implant.  
 
 
 
 
 
 
 
 
 
 
 
 
 

ABT-CIP-10382 Ver. A  
Study Name: Hong Kong and Taiwan HM3 PMS 
Post Market Surveillance Plan  
 
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Identify patients with planned 
HM3 implant per approved 
indications 
Subject Follow-up Visits*: 
 
Month 1 ± 7 days 
Month 3 ± 30 days 
Month 6 ± 30 days 
Month 12 ± 30 days 
Month 24 ± 60 days 
End of Surveillance 
Participation 
Patient excluded; 
documented in 
Recruitment Log. 
Enrolled 
Yes 
HM3 Implant 
Figure 2: Post Market Surveillance Flowchart  
 
 
* The patients will be followed 
until 24 months visit or until 
they experience an outcome, 
whichever comes first. 
Patient consents; 
ICF signed? 
Recruitment 
No 

ABT-CIP-10382 Ver. A  
Study Name: Hong Kong and Taiwan HM3 PMS 
Post Market Surveillance Plan  
 
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Measures Taken to Avoid and Minimize Bias 
Participant selection bias will be minimized by training the PMS sites to provide all patients, that 
meet the HM3 commercially approved labelling indications, the opportunity to participate in this 
PMS. A log should be maintained of any subjects that are not included in this Registry and 
reasons for non-inclusion.      
 
Suspension or Early Termination of the Post Market Surveillance 
While no formal statistical rule for early termination of this PMS is defined, the Sponsor reserves 
the right to discontinue the PMS at any stage or reduce the follow-up period with suitable written 
notice to the investigator.  
Should the Sponsor discontinue the post market surveillance, sites will follow subjects per 
routine hospital practice with device-related adverse events (AEs) reported to the Sponsor as 
per vigilance/commercial reporting requirements. The investigator shall return all post market 
surveillance materials to the Sponsor and provide a written statement to the IRB (if applicable). 
All applicable post market surveillance documents shall be subject to the same retention policy 
as detailed in Section 11.5 of the PMS plan.  
 
If the Sponsor suspends or prematurely terminates the post market surveillance at an individual 
site in the interest of safety, the Sponsor will inform all other Principal Investigators. 
 
If suspension or premature termination occurs, the Principal Investigator or authorized designee 
will promptly inform the enrolled subjects at his/her site, and return patients to their standard 
medical treatment, if appropriate. 
 
A Principal Investigator, IRB or regulatory authority may also suspend or prematurely terminate 
participation in the clinical investigation at the investigational site(s) for which they are 
responsible. The investigators will follow the requirements specified in the Clinical Trial 
Agreement.  
 
If a suspended investigation is to be resumed, a prior approval should be obtained from the IRB 
and a notification should be sent to the regulatory bodies. 
4.0 
POST MARKET SURVEILLANCE OUTCOMES  
The objective of this PMS is to gather clinical and functional outcomes data from a country 
specific patient population that meets the HM3 commercially approved labelling indications.  
 
The primary outcomes that will be evaluated in this post market surveillance include: functional 
status as measured with the 6MWT, NYHA classification of heart failure severity, quality of life 
measured with the EQ-5D-5L questionnaire, rates of survival, transplants, pump explant or 
exchange, device malfunction, reoperations, rehospitalizations and incidence of adverse events. 
Adverse events include, but are not limited to, neurological dysfunction, bleeding, device 
thrombosis and infections, that meet the definitions in Appendix II; device malfunctions will be 
recorded under the general category of Device Deficiencies (section 7.1.3) and is further 
explained in Appendix II.  

ABT-CIP-10382 Ver. A  
Study Name: Hong Kong and Taiwan HM3 PMS 
Post Market Surveillance Plan  
 
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5.0 
SUBJECT SELECTION AND WITHDRAWAL  
 
Subject Population 
This post market surveillance will enroll advanced heart failure patients of all genders with a 
planned HM3 implant, that meet the HM3 commercially approved labelling indications. Patients 
must provide written informed consent prior to sites conducting any investigation-specific 
procedures not considered standard of care.  
 
Subject Recruitment/Screening and Informed Consent 
 Subject Recruitment and Screening 
A member of the site’s post market surveillance team, previously trained to the PMS plan, must 
evaluate patients for the PMS eligibility criteria (Section 5.3), and if applicable, will enter the 
patients into a site-specific recruitment log. A patient who does not satisfy all eligibility criteria 
prior to informed consent is considered a recruitment failure and should not be enrolled in the 
post market surveillance.  
 
Sites will ask the patients meeting the eligibility criteria to sign an Informed Consent form 
following the established Informed Consent process (described in Section 5.2.2) if they wish to 
participate in the post market surveillance. Sites will enter these patients into the recruitment 
log.   
 Informed Consent 
The Investigator or his/her authorized designee (if applicable) will conduct the Informed Consent 
process, as required by applicable regulations and the center’s IRB. This process will include a 
verbal discussion with the patient on all aspects of the post market surveillance that are relevant 
to the patient’s decision to participate, such as details of post market surveillance procedures, 
anticipated benefits, and potential risks of post market surveillance participation. Sites must 
inform patients about their right to withdraw from the post market surveillance at any time and 
for any reason without sanction, penalty, or loss of benefits to which the patient is otherwise 
entitled. Withdrawal from the post market surveillance will not jeopardize their future medical 
care or relationship with the investigator.  
 
During the discussion, the Principal Investigator or his/her authorized designee will avoid any 
improper influence on the patient and will respect patient’s legal rights. Financial incentives will 
not be given to patients. Patients may be compensated for time and travel directly related to the 
participation in the post market surveillance. The site shall provide the patient with the Informed 
Consent form written in a language that is understandable to the patient and that has been 
approved by the center’s IRB. The patient shall have adequate time to review, ask questions, 
and consider participation. The Principal Investigator or his/her authorized designee will make 
efforts to ensure that the patient understands the information provided. If the patient agrees to 
participate, they must sign and date the Informed Consent form, along with the person obtaining 
the consent prior to any post market surveillance-specific procedures. The site will file the 
signed original in the patient’s hospital or research charts and provide a copy to the patient. 

ABT-CIP-10382 Ver. A  
Study Name: Hong Kong and Taiwan HM3 PMS 
Post Market Surveillance Plan  
 
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Sites should report any failure to obtain informed consent from a patient to the Sponsor within 5 
working days and to the reviewing center’s IRB according to the IRB’s reporting requirements. 
 
If, during the post market surveillance, new information becomes available that can significantly 
affect a subject's future health and medical care, the Principal Investigator or his/her authorized 
designee (if applicable) will provide this information to the subject. If relevant, sites will ask the 
subject to confirm their continuing informed consent in writing.  
 
This PMS will not permit informed consent via legally authorized representatives. Therefore, 
incapacitated individuals, including the mentally handicapped or individuals without legal 
authority or individuals under the age of 18 or local age of legal consent, are excluded from the 
PMS population. Furthermore, individuals unable to read or write are excluded from the PMS 
population. 
 
Eligibility Criteria 
All patients at the participating sites that are determined to meet the HM3 commercially 
approved labelling indication and have a planned HM3 implant are eligible to participate in this 
PMS. Assessment for eligibility criteria is based on medical records of the site and interview with 
a candidate patient.  
 
Subject Enrollment 
A patient is considered enrolled in the post market surveillance from the moment the patient 
provides written informed consent. 
 
Subject Withdrawal and Discontinuation 
All subjects enrolled in the study shall remain in the post market surveillance until they 
performed the 24 month follow-up or they experience an outcome (death, transplant, HM3 
explant or exchange, or withdrawal), whichever comes first; however, a subject’s participation in 
any clinical investigation is voluntary and the subject has the right to withdraw at any time 
without penalty or loss of benefit. Conceivable reasons for discontinuation may include, but not 
be limited to, the following: 
• 
Physician or subject voluntary withdrawal  
• 
Subject lost-to follow-up as described below  
• 
Non-compliance with the PMS plan  
• 
Subject is not on primary HM3 support 
 
Sites must notify the Sponsor of the reason(s) for subject discontinuation. Investigators must 
also report this to their respective IRB as defined by their institution’s procedure(s).  
 
No additional follow-up is required, or data recorded from subjects once withdrawn from the post 
market surveillance, except for the status (deceased/alive). 
 

ABT-CIP-10382 Ver. A  
Study Name: Hong Kong and Taiwan HM3 PMS 
Post Market Surveillance Plan  
 
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In case of subject withdrawal of consent, the site should make attempts to schedule the subject 
for a final post market surveillance visit. At this final follow-up visit, the subject will undergo the 
following assessments: 
• 
Adverse events since the last follow-up 
• 
Transplant, explant/exchange or device deficiency since the last follow-up 
• 
Subject outcomes 
 
Lost-to-Follow-up 
 
If the subject misses two consecutive scheduled follow-up time points and the attempts at 
contacting the subject detailed below are unsuccessful, then the subject is considered lost-to-
follow-up. Site personnel shall make all reasonable efforts to locate and communicate with the 
subject (and document these efforts in the source documents), including the following, at each 
contact time point: 
• 
A minimum of two telephone calls on different days over the specified follow-up windows 
to contact the subject should be recorded in the source documentation, including date, 
time and initials of site personnel trying to make contact. 
• 
If these attempts are unsuccessful, the site should send a letter (certified if applicable) to 
the subject. 
• 
If a subject misses one or more non-consecutive follow-up contact time points, it will be 
considered a missed visit. The subject may then return for subsequent visits. If the 
subject misses two consecutive time points and the above-mentioned attempts at 
communicating with the subject are unsuccessful, the subject will be considered lost-to-
follow-up.  
 
Note: Telephone contact with general practitioner, non-PMS cardiologist or relative without the 
presence of the subject or indirect documentation obtained via discharge letters will not be 
considered as subject contact.  
 
Number of Subjects  
All consecutive patients at the participating sites with a planned HM3 implant, that meet the  
HM3 commercially approved labelling indications, will be enrolled in the PMS. We expect, 
approximately 30 subjects will be enrolled. 
 
Total Expected Duration of the Post market surveillance 
Subject follow-up will occur at the time of Baseline/Enrollment, HM3 Implant, and at 1, 3, 6, 12 
and 24 months post HM3 implant, unless the subject experiences an outcome. The total 
duration of the Post Market Surveillance is estimated to be 36 months.  

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6.0 
TREATMENT AND EVALUATION OF ENDPOINTS 
 
Baseline/Enrollment  
The assessments listed in Table 1 should be performed prior to the HM3 implant.  
 
Table 1: Pre-implant Baseline Assessments 
Study Activity 
Data Collection 
Informed Consent 
Explain post market surveillance study and obtain informed consent as 
described in section 5.2.2  
Demographics 
Age, height, gender, ethnic origin, blood type 
General and Cardiac 
Medical History 
• 
Etiology and duration of heart failure  
• 
Therapeutic intent (BTT/BTC/DT)1  
• 
Arrhythmias  
• 
Valve repair/replacement  
• 
History of organ transplant, stroke, TIA, smoking, bleeding2, valve 
disease, hypertension, MI, peripheral non-CNS 
thrombosis/thromboembolism, substance abuse (drug/alcohol), 
drug/radiation toxicity, peripheral vascular disease, carotid artery 
disease, coronary artery disease, coronary stents, CABG, cancer, 
allergies, renal insufficiency/failure and psychiatric, head, ear, nose, 
throat, dermatological, coagulation, inflammatory, gastrointestinal, 
genitourinary, respiratory or endocrine disorders, cardiac arrest, aortic 
stenosis.  
• 
Cardiac rhythm management device  
• 
Intra-aortic balloon pump  
• 
Other pre-implant circulatory support  
• 
CardioMEMS™, MitraClip™ 
Vital Signs 
Weight, blood pressure and method, and heart rate 
Medications 
Inotropes, Anticoagulation/Antiplatelet (aspirin, Persantine, Plavix, warfarin, 
Other), antibiotics, vasodilators, diuretics, anti-arrhythmic, ACEi, ARB and 
beta blockers. 
Laboratory 
Assessments3 
Hemoglobin, hematocrit, white blood cell count, platelets, creatinine, 
estimated glomerular filtration rate, liver function tests (AST, ALT, total 
bilirubin, albumin, pre-albumin), blood urea nitrogen, INR, LDH. 

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Study Activity 
Data Collection 
Right Heart 
Catheterization4 
Central venous pressure (CVP) or right atrial pressure (RAP), systolic, 
diastolic and mean pulmonary artery pressure (PAS, PAD, PAM), pulmonary 
capillary wedge pressure (PCWP), cardiac output (CO), and cardiac index (CI) 
Echocardiogram4 
Type of assessment, LVEF, LVEDD, LVESD, AI, MR, TR, PR, including 
severity and/or grade, and presence of LV or LA thrombus, and aortic valve 
opening ratio 
Functional Capacity 
6-minute Walk Test5, NYHA Class, INTERMACS Profile 
Quality of Life 
EQ-5D-5L quality of life questionnaire 
1 BTT – bridge to transplant; BTC – bridge to transplant candidacy; DT – destination therapy.  
2 Bleeding includes diverticular disease, diagnosed arteriovenous malformations (AVMs), GI ulcer(s), 
anemia and/or erythropoietin treatment. 
3 Most recent results obtained within 30 days prior to implant will be permitted as baseline data. 
4 If collected per standard of care, most recent results within 30 days prior to implant. 
5 If subject is able, else reason must be provided if not performed. 
 
Implant 
The data in Table 2 will be collected for each subject’s HM3 implant procedure. 
 
Table 2. Data to be collected at the time of HM3 implant. 
Study Activity 
Data Collection 
HM3 System Information 
VAD serial number, reference number and date of implant of entire 
implanted system 
Implant Data 
• 
Presence of intracardiac (LA or LV) thrombus  
• 
Concurrent procedures 
• 
Administration of factor VII, vitamin K or anti-fibrinolytic  
• 
Pump position 
• 
Apical cuff attachment method 
• 
Drive line related information 
• 
Transfusion of whole blood, packed red blood cells [PRBC], 
fresh frozen plasma [FFP], platelets, cryoprecipitate, or Cell 
Saver  
• 
Intraoperative medications 
• 
Cardiopulmonary bypass (CPB) time  

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• 
ECMO 
• 
Total implant time  
• 
Location of outflow anastomoses  
• 
Additional post-implant MCS 
• 
Hematocrit value 
Pump Parameters 
Pump speed, flow, power and pulsatility index 
 
Follow-Up Visit Assessments  
The assessments listed in Table 3 will be performed at all other visits (i.e. at 1, 3, 6, 12 and 24 
months) post HM3 Implant, unless the subject experiences an outcome; for the purposes of this 
PMS a month is defined as 30 days. The required assessments, follow-up schedule, and 
associated visit windows (Table 4) are generally aligned with SOC LVAD patient follow up. All 
follow-up visits are based on the HM3 implant date.  
Table 3. Follow-up visit assessments. 
Study Activity 
Definition 
Subject Status 
Whether the subject is on HM3 LVAD support, if not, what was the 
outcome the patient experienced (i.e. death, transplant, withdrawn, pump 
exchange or explant) 
Vital Signs 
Weight, blood pressure and method of blood pressure measurement, and 
heart rate 
Pump Parameters 
Pump speed, flow, power and pulsatility index 
Medications 
Inotropes, anticoagulation/antiplatelet (Aspirin, Persantine, Plavix, 
warfarin, Other), antibiotics, vasodilators, diuretics, anti-arrhythmic, ACEi, 
ARB and beta blockers. 
Laboratory Assessments 
 
Hemoglobin, hematocrit, white blood cell count, platelets, creatinine, 
estimated glomerular filtration rate, liver function tests (AST, ALT, total 
bilirubin, albumin, pre-albumin), blood urea nitrogen, INR, LDH. 
Echocardiogram1  
LVEF, LVEDD, LVESD, AI, MR, TR, PR, including new onset, severity 
and/or grade, and presence of LV or LA thrombus, and aortic valve 
opening ratio 
Functional Capacity 
6-minute Walk Test and NYHA Class 
Quality of Life 
EQ-5D-5L quality of life questionnaire 
1If collected per SOC. 
 
The follow-up visit must occur within the designated window (Table 4). The assessments for a 
single visit do not have to occur on the same date, but must occur within the designated 
window, or will be considered a protocol deviation. The Sponsor understands that some lab 
results may be received several days after the visit has occurred, in these instances the date 

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the blood draw occurred will be considered as the date of the lab assessment. All subjects 
should be asked, at each follow up visit, if they were seen at an outside facility. If so, medical 
records from any facility that has seen the patient must, with the subject’s consent, be 
requested and reviewed for potential adverse events.  
 
Table 4. Follow-up visit windows. 
Visit 0 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Baseline/ 
Enrollment 
Implant 
Month 1 
± 7 days 
Month 3 
± 30 days 
Month 6 
± 30 days 
Month 12 
± 30 days 
Month 24 
± 60 days 
Patients will be followed until the 24 months visit or they experience an outcome. 
 
 
Unscheduled Visits 
 Adverse Events 
Relevant data related to adverse events will be collected as they occur. For additional details 
regarding adverse events, including mandated reporting timelines, refer to section 7. 
 Reoperations 
Data related to any cardiac or non-cardiac reoperations, occurring after enrollment will be 
collected. Reoperations must be reported to the Sponsor through the EDC system within three 
days of awareness of the event or, at the latest, if the operation was unknown to the implanting 
site (i.e. occurring at another facility), during the next follow-up visit. For pump exchanges, 
additional implant data will be collected, including exchange status and pump exchange type.  
 Rehospitalizations 
All rehospitalizations with associated reasons will be captured during the follow-up period for all 
subjects. While hospitalized, the follow-up visit assessments will continue to be performed 
according to the follow-up schedule. Hospitalizations must be reported to the Sponsor through 
the EDC system within three days of awareness or discovery of the event or, at the latest, if the 
hospitalization is unknown to the implanting site (i.e. occurring at another facility), during the 
next follow-up visit.  
 
Subject Outcomes 
Subjects will be followed until the 24-month follow-up is completed or until they experience an 
outcome, whichever occurs first. Outcomes include death, heart transplantation, HM3 exchange 
or explant, and withdrawal from the PMS. Outcomes must be reported to the Sponsor through 
the EDC system immediately upon discovery of the event.  
 
Schedule of Events  
All of the post market surveillance assessments and their schedule are listed in Table 5.  

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Table 5. Schedule of assessments.  
Assessment 
Baseline/ 
Enrollment 
HM3 Implant 
Month 11 
(± 7 days) 
Month 31 
(± 30 days) 
Month 61 
(± 30 days) 
Month 121 
(± 30 days) 
Month 24  
(± 60 days) 
As Occurs or 
Unscheduled 
Eligibility Assessment 
X 
 
 
 
 
 
 
 
Informed Consent 
X 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
General and Cardiac Medical History 
X 
 
 
 
 
 
 
 
Right Heart Catheterization 
X2 
 
 
 
 
 
 
X2 
HM3 Information 
 
X 
 
 
 
 
 
X3 
Implant Data 
 
X 
 
 
 
 
 
X3 
Vital Signs 
X 
 
X 
X 
X 
X 
X 
X 
Laboratory Assessments 
X 
 
X 
X 
X 
X 
X 
X 
Echocardiogram 
X2 
 
X2 
X2 
X2 
X2 
X2 
X2 
Medications 
X 
 
X 
X 
X 
X 
X 
X 
Functional Capacity 
X 
 
X 
X 
X 
X 
X 
X2 
EQ-5D-5L Quality of Life Questionnaire 
X 
 
X 
X 
X 
X 
X 
X2 
Pump Parameters 
 
X 
X 
X 
X 
X 
X 
X 
Subject Status 
 
 
X 
X 
X 
X 
X 
X 
Subject Outcome 
 
 
 
 
 
 
 
X 
Rehospitalizations 
 
 
 
 
 
 
 
X 
Adverse Events 
 
 
 
 
 
 
 
X 
Device Deficiencies4,5 
 
 
 
 
 
 
 
X 
Modified Rankin Score (MRS) Assessment6 
 
 
 
 
 
 
 
X 
Reoperations (excluding primary implant) 
 
 
 
 
 
 
 
X 
Protocol Deviations 
X 
X 
X 
X 
X 
X 
X 
X 
COVID-19 questions (if applicable) 
X 
X 
X 
X 
X 
X 
X 
X 
Note: Patients will be followed until the 24 months visit or they experience an outcome, whichever comes first. 
1One month = 30 days. 
2If performed as standard of care. 
3Implant data for HM3 to HM3 exchange(s) and only relevant information for non-HM3 exchange. 
4Device deficiencies that result in adverse events only. Please see section 7.3.2 for further information. 

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Assessment 
Baseline/ 
Enrollment 
HM3 Implant 
Month 11 
(± 7 days) 
Month 31 
(± 30 days) 
Month 61 
(± 30 days) 
Month 121 
(± 30 days) 
Month 24  
(± 60 days) 
As Occurs or 
Unscheduled 
5Device malfunction is included within the definition of Device Deficiency. 
6 Required only if a stroke has occurred 
7.0 
Adverse Events 
To comply with worldwide standards and guidelines on clinical investigation adverse event 
reporting, the Sponsor has adopted uniform and worldwide applicable standard definitions and 
reporting timelines to be used and adhered to by the investigators.  
 
Definition 
 Adverse Event 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users or other 
persons, whether or not related to the medical device under investigation. 
 
As part of ISO14155 Section 3.2, the Adverse Event definition has the following notes: 
 
Note 1: This definition includes events related to the medical device under investigation or the 
comparator. 
Note 2: This definition includes events related to the procedures involved. 
Note 3: For users or other persons, this definition is restricted to events related to medical 
devices under investigation. 
 Serious Adverse Event 
If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).  
 
a) Led to a death, 
b) Led to a serious deterioration in health of the subject, that either resulted in  
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function, or 
3. in-patient hospitalization or prolongation of existing hospitalization, or 
4. medical or surgical intervention to prevent life threatening illness or injury or 
permanent impairment to a body structure or a body function. 
5. chronic disease  

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c) Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
 
Note: A planned hospitalization for a pre-existing condition, or a procedure required by the PMS 
plan without a serious deterioration in health, is not considered to be an SAE. 
 
 Device Deficiency  
Device deficiency is defined as an inadequacy of a medical device related to its identity, quality, 
durability, reliability, safety or performance, such as malfunction, misuse or use error and 
inadequate labeling. This includes the failure of the device to meet its performance 
specifications or otherwise perform as intended. Note: performance specifications include all 
claims made in the labeling of the device. 
 
Device Relationship 
Determination of whether there is a reasonable possibility that the device under investigation 
caused or contributed to an AE is to be determined by the Investigator and recorded on the 
appropriate Case Report Form (CRF). Determination should be based on the assessment of 
temporal relationships, evidence of alternative etiology, medical/biologic plausibility and patient 
condition (pre-existing condition). If an AE or Device Deficiency is determined to be pump-
related or possibly related, pump parameters should be reported in the appropriate CRF. 
 
Adverse Event and Device Deficiency Reporting 
 Adverse Event Reporting 
Safety surveillance and reporting starts as soon as the patient is enrolled in the post market 
surveillance. Safety surveillance and reporting will continue until sites perform the last follow-up 
visit, the subject is deceased, the subject concludes participation in the post market 
surveillance, or the subject withdraws from the post market surveillance. Sites will collect all 
adverse event data, including deaths and device deficiency data, throughout the period defined 
above and will report these events to the Sponsor on a CRF. Sites should update additional 
information regarding an adverse event on the appropriate CRF.  
 
Unchanged, chronic, non-worsening or pre-existing conditions are not AEs and should not be 
reported.  
 
The Sponsor will provide an offline form to allow the investigator to report SAEs in the event the 
entry cannot be made in the EDC. This does not replace the EDC reporting system. Sites must 
still enter all information in the EDC system as soon as feasible. 
 
Non-cardiac related abnormal laboratory values will not be considered AEs unless:  
1. the investigator determined that the value is clinically significant, OR 
2. the abnormal lab value required intervention, OR 
3. the abnormal lab value required subject withdrawal from the post market surveillance 

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All adverse events will be collected on each subject throughout the follow up period – until the 
subject reaches an outcome or withdraws or until the surveillance ends. Causes of death will be 
captured for all subjects who expire during follow up.  
 
SAE Reporting 
The investigator must report all SAEs to the Sponsor as soon as possible but no later than 
outlined below.  
 
Clinical Site 
Reporting timelines 
All Sites 
Sites must report SAEs to the Sponsor no later than 3 calendar days 
from the day the site personnel became aware of the event or as per the 
investigative site’s local requirements, if the requirement is more stringent 
than those outlined. 
 
Sites must record the date the site staff became aware that the event met the criteria of an SAE 
in the source document. The Investigator will further report the SAE to the local IRB according 
to the institution’s IRB reporting requirements.  
 Device Deficiency Reporting 
Device deficiencies should be reported on the appropriate CRF form only if they are associated 
with any adverse events.  
 
The investigator should report device deficiencies associated with AEs to the Sponsor as soon 
as possible but no later than outlined below.  
 
 
Clinical Sites 
Reporting timelines 
All Sites 
Device deficiencies must be reported to the Sponsor no later than 3 
calendar days from the day the site personnel became aware of the 
event or as per the investigative site’s local requirements, if the 
requirement is more stringent than those outlined. 
 
 
Device deficiencies should be reported to the IRB per the investigative site’s local requirements.  
An offline form will be made available to allow the investigator to report device deficiencies, if 
the entry cannot be made in the EDC system. This does not replace the EDC reporting system. 
All information must still be entered in the EDC system as soon as feasible.  
 
In case a device deficiency occurred before the patient ID number has been assigned, the 
device deficiency should be reported to the Sponsor via the offline reporting form.  
 

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Irrespective of the device deficiency requirement per this investigation, the site must submit all 
device deficiencies to Sponsor Product Performance Group in order to be captured in the 
Sponsor complaints database.  
 Adverse Event and Device Deficiency Reporting to Country Regulatory Authorities 
by the Sponsor  
The Sponsor will report SAEs and reportable device deficiencies to the country regulatory 
authority, per local requirements. All reportable events will be reported to the Competent 
Authority per the applicable regulations by the Product Performance Group (PPG). 
8.0 
STATISTICAL CONSIDERATIONS 
 
Analysis Populations 
Data from all enrolled subjects will be used in the analyses. Subjects will be followed until they 
experience an outcome (death, transplant, HM3 exchange/explant or withdrawal) or the 24 
month follow-up visit is completed, whichever occurs first.  
 
Statistical Analyses  
In general, continuous data will be presented with measures of central tendency (e.g. mean, 
median) and deviation (e.g. standard deviation, inter-quartile range). Discrete events will be 
presented as frequency and percentage.   
 Primary Efficacy Endpoint 
Primary efficacy endpoint is defined as the overall survival to transplant, myocardial recovery or 
on device support free of debilitating stroke (Modified Rankin Score >3) or reoperation for pump 
replacement during the 2-year surveillance period; this will be assessed using the Kaplan-Meier 
product-limit method along with a competing outcomes graph. Subjects who are urgently 
transplanted due to a HeartMate 3 malfunction will be considered to have experienced a primary 
endpoint event, as will subjects who expire, suffer a debilitating stroke or have their HeartMate 3 
exchanged due to a device failure. Subjects who are transplanted (except as described above), 
explanted for recovery, withdraw from the trial or are lost to follow-up will be censored at that 
time in the analysis. 
 Primary Safety Endpoint 
Primary safety endpoint is measured by all pre-defined adverse events. Cumulative occurrence 
of adverse events during the surveillance period will be presented as percent of patients with 
adverse events and events per patient year of support. 
 Secondary Efficacy and Safety Endpoints 
8.2.3.1 Six-minute Walk Test  
Subjects may not be able to walk due to heart failure, especially at baseline. Subjects unable to 
walk due to heart failure will receive a score of 0 meters. For all other reasons, missing data will 

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remain missing and will not be included in the analysis. The 6-minute Walk test will be 
conducted at all follow-up visits until the end of the surveillance period. The overall mean, 
median, standard deviation, minimum and maximum will be presented for all follow-up visits. 
Differences in walking distance between each visit and baseline will be calculated and assessed 
for improvements using paired, nonparametric Wilcoxon signed-rank test. In addition, box plots 
will be used to show changes in walking distance over time. 
8.2.3.2 NYHA 
Subjects’ NYHA Functional Status will be assessed at all scheduled follow-up visits until the end 
of the surveillance period. Percent of subjects in each NYHA class will be presented for all 
follow-up visits. For comparison, patients will be grouped into NYHA Class I/II (No limitation and 
Slight limitation of physical activity) vs. NYHA Class III/IV (Marked limitation and Inability to carry 
out physical activities).  McNemar’s test will then be used to assess if there is an increase in 
proportion of Class I and II subjects at each visit comparing to the baseline.  In addition, bar 
charts will be used to show changes in NYHA classification over time. 
8.2.3.3 EQ-5D-5L quality of life (QoL) questionnaire 
Subject’s quality of life will be measured by the EQ-5D-5L QoL questionnaire at baseline and all 
visits after HM3 implant until the end of surveillance period. The overall mean, median, standard 
deviation, minimum and maximum will be presented for all follow-up visits. Differences in QoL 
Score between each visit and baseline will be calculated and assessed for improvements using 
paired, nonparametric Wilcoxon signed-rank test. In addition, box plots will be used to show 
changes in QoL over time.   
8.2.3.4 Rehospitalization and Reoperation 
Frequency and reason will be reported for rehospitalization and reoperation. Freedom from 
rehospitalization and reoperation will be assessed using the Kaplan-Meier product-limit method.  
8.2.3.5 Device Malfunctions  
All suspected HM3 device malfunctions will be reported. Data on device malfunctions will be 
analyzed and tables will be created that report the following: 
- 
The component of the device involved 
- 
Days to the malfunction 
- 
Action taken in response to the malfunction 
- 
Reoperations due to malfunction 
- 
Death due to malfunction 
Note: Device malfunctions will be collected under the general category of Device Deficiencies 
(section 7.1.3) and the term is defined further in Appendix II. 
 
Sample Size Calculation  
Sample size is based on an estimate of the number of consecutive patients likely to be 
implanted with a HM3 at the participating sites during the surveillance period.  

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Timing of Analysis 
All endpoints will be assessed at the end of the surveillance period.  
 
Subgroup Analysis 
No subgroup analyses are planned for this PMS.  
 
Procedures for Accounting for Missing Data 
Data collected outside of the study visit window will be excluded from the analysis. Except for 6-
minute Walk Test stated above, missing data will not be imputed.  
 
Planned Interim Analysis 
No interim analyses are planned for this PMS. 
 
Deviations from Statistical Plan 
The Sponsor will document any major changes to the analysis plan in an amendment to the 
SAP and any less significant changes to the planned analyses in the final report.   
9.0 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
The investigator/institution will permit direct access to source data/documents for performing 
post market surveillance-related monitoring, audits, IRB review and regulatory inspections. 
 
Subjects providing informed consent are agreeing to allow post market surveillance monitors or 
regulatory authorities, including foreign countries, to review in confidence any records identifying 
the subjects in this post market surveillance. This information may be shared with regulatory 
agencies; however, the Sponsor undertakes not to otherwise release the subject's personal and 
private information. 
10.0 QUALITY CONTROL AND QUALITY ASSURANCE 
 Selection of Clinical Sites and Investigators 
The Sponsor will select investigators qualified by training and experience to participate in the 
post market surveillance. Sites will be selected based upon review of a recent site assessment, 
if applicable, and the qualifications of the investigators who will participate in the post market 
surveillance. 
 PMS plan Amendments  
The Sponsor will provide approved PMS plan amendments to the Investigators prior to 
implementing the amendment. The Principal Investigator is responsible for notifying the IRB or 

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equivalent committee of the PMS plan amendment (administrative changes) or obtaining IRB’s 
approval of the PMS plan amendment (changes in subject care or safety), according to the 
instructions provided by the Sponsor with the PMS plan amendment.   
 
Sites must document in writing acknowledgement/approval of the PMS plan amendment by the 
IRB prior to implementation of the PMS plan amendment. Sites must also provide copies of this 
documentation to the Sponsor. 
 Training 
All Investigators and post market surveillance personnel are required to attend Sponsor training 
sessions, which may be conducted at an Investigator's meeting, a site initiation visit, or other 
appropriate training sessions. Over-the-phone or self-training may take place as required. 
Training of Investigators and post market surveillance personnel will include, but is not limited 
to, the PMS plan requirements, investigational device usage, electronic case report form 
completion, and post market surveillance personnel responsibilities. All Investigators and post 
market surveillance personnel that are trained must sign a training log (or an equivalent) upon 
completion of the training. Prior to signing the training log, Investigators and post market 
surveillance personnel must not perform any PMS-related activities that are not considered 
standard of care at the site.  
 Monitoring  
Sponsor and/or designee will monitor the post market surveillance over its duration according to 
the PMS plan-specific monitoring plan which will include the planned extent of source data 
verification.  
 
Prior to initiating any procedure, the Sponsor monitor (or delegate) will ensure that the following 
criteria are met:  
 
• 
The investigator understands and accepts the obligation to conduct the post market 
surveillance according to the PMS plan and applicable regulations and has signed the 
Clinical Trial Agreement.  
• 
The Investigator and his/her staff should have sufficient time and facilities to conduct the 
post market surveillance and should have access to an adequate number of appropriate 
subjects to conduct the post market surveillance.  
• 
Sites must have source documentation (including original medical records) to 
substantiate proper informed consent procedures, adherence to PMS procedures, 
adequate reporting and follow-up of adverse events, accuracy of data collected on case 
report forms, and device information.  
• 
The Investigator/site will permit access to such records and will maintain a monitoring 
visit sign-in log at the site. The Investigator will agree to dedicate an adequate amount of 
time to the monitoring process. The Investigator and/or research coordinator will be 
available for monitoring visits. It is expected that the Investigator will provide the monitor 
with a suitable working environment for review of post market surveillance-related 
documents. 

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 Deviations from PMS plan 
The Investigator should not deviate from the PMS plan for any reason except in cases of 
medical emergencies when the deviation is necessary to protect the rights, safety, and well-
being of the subject, or to eliminate an apparent immediate hazard to the subject. In that event, 
the Investigator will notify Sponsor immediately by phone or in writing.  
 
The Sponsor will not grant any waivers for PMS plan deviations. Sites must report all deviations 
to the Sponsor using the Deviation CRF. The Sponsor will monitor the occurrence of deviations 
from the PMS plan for evaluation of investigator compliance to the PMS plan and regulatory 
requirements and handle according to written procedures. Investigators will inform their IRB or 
equivalent committee of all PMS plan deviations in accordance with their specific IRB or 
equivalent committee reporting policies and procedures.  
 
In the event of repeated non-compliance, as determined by the Sponsor, a Sponsor’s monitor or 
company representative will attempt to secure compliance by one or more of the following (and 
not limited to):  
• 
Visiting the investigator and/or delegate 
• 
Telephoning the investigator and/or delegate 
• 
Corresponding with the investigator and/or delegate 
 
Repeated non-compliance with the signed agreement, the PMS plan, or any other conditions of 
the post market surveillance may result in further escalation in accordance with the Sponsor’s 
written procedures, including securing compliance or, at its sole discretion, the Sponsor may 
terminate the investigator's participation in the post market surveillance.  
 Quality Assurance Audit 
A Sponsor representative or designee may request access to all post market surveillance 
records, including source documentation, for inspection during a Quality Assurance audit.  
 
If an investigator is contacted by a Regulatory Agency in relation to this post market 
surveillance, the Investigator will notify Sponsor immediately. The Investigator and Research 
Coordinator must be available to respond to reasonable requests and audit queries made during 
the audit process. The Investigator must provide the Sponsor with copies of all correspondence 
that may affect the review of the current post market surveillance (e.g. Inspectional 
Observations, Warning Letters, Inspection Reports, etc.). The Sponsor may provide any needed 
assistance in responding to regulatory audits.  
11.0 DATA HANDLING AND RECORD KEEPING  
Sponsor and/or its affiliates will maintain documentation of the systems and procedures used in 
data collection for the duration of the post market surveillance. CRF data collection will be 
performed through a secure web portal and only authorized personnel will access the EDC 
system using a unique username and password to enter, review or correct data. Passwords and 

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electronic signatures will be strictly confidential.  The data will be subjected to consistency and 
validation checks within the EDC system and supplemental review by the Sponsor.   At the end 
of the post market surveillance, completed CRF images with the date-and-time stamped 
electronic audit trail indicating the user, the data entered, and any reason for change (if 
applicable) will be provided to the investigational sites, if requested.  
 
For the duration of the post market surveillance, the Investigator will maintain complete and 
accurate documentation including, but not limited to, medical records, post market surveillance 
progress records, laboratory reports, CRFs, signed ICFs, device accountability records (if 
applicable), correspondence with the IRB and post market surveillance monitor/Sponsor, 
adverse event reports, and information regarding subject discontinuation or completion of the 
post market surveillance. 
 Protection of Personally Identifiable Information 
The Sponsor respects and protects personally identifiable information collected or maintained 
for this post market surveillance. The Sponsor implements technical and physical access 
controls to ensure that Personal Information is accessible only to and processed only on a ‘need 
to know’ basis, including periodic review of access rights, and revocation of access when an 
individual’s employment is terminated or the individual transitions to a role that does not require 
access to Personal Information, and appropriate restrictions on physical access to premises, 
facilities, equipment, and records containing Personal Information. 
 
The Sponsor requires the investigational sites to enter only pseudonymous Personal 
Information (key-coded) necessary to conduct the post market surveillance, such as the 
patient’s medical condition, treatment, dates of treatment, etc., into Sponsor’s data management 
systems. The Sponsor discloses as part of the post market surveillance informed consent 
process that some Sponsor representatives still may see Personal Information at the 
participating sites for technical support of the participating physicians on the device implant or 
procedures, monitoring and quality control purposes. All parties will observe confidentiality of 
Personal Information always throughout the post market surveillance. All reports and data 
publications will preserve the privacy of each subject and confidentiality of his/her information. 
 
The Sponsor data management systems and processes were designed, developed, and tested 
according to industry standards to appropriately safeguard Confidential Information (including 
any Personal Information) against unauthorized access and/or interference by third parties, 
intrusion, theft, destruction, loss or alteration. Post market surveillance data are encrypted in 
transit and at rest.  
 
The Sponsor maintains a Privacy Incident procedure that complies in all respects with 
Applicable Law and industry best practices. 
 Data Management Plan 
A Data Management Plan (DMP) will describe procedures used for data review, data cleaning, 
and issuing and resolving data discrepancies. If appropriate, the Sponsor may update the DMP 

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throughout the duration of the post market surveillance. The Sponsor will track and document 
control all revisions. 
 Source Documentation 
 
Regulations require the Investigator to maintain information in the subject’s original medical 
records that corroborates data collected on the CRFs. To comply with these regulatory 
requirements, sites should include the following information in the subject record at a minimum 
and if applicable to the post market surveillance: 
• 
Medical history/physical condition of the subject before involvement in the post market 
surveillance sufficient to verify PMS entry criteria 
• 
Dated and signed notes on the day of entry into the post market surveillance referencing the 
Sponsor, PMS plan number, subject ID number, and a statement that informed consent was 
obtained 
• 
Dated and signed notes from each subject visit (for specific results of procedures and 
exams) 
• 
AEs reported and their resolution, including supporting documents, such as discharge 
summaries, catheterization laboratory reports, ECGs, and lab results including 
documentation of site awareness of SAEs and of investigator assessment of device 
relationship for SAEs. 
• 
PMS plan-required laboratory reports and 12-lead ECGs reviewed and annotated for clinical 
significance of out of range results (if applicable).  
• 
Notes regarding PMS plan-required and prescription medications taken during the post 
market surveillance (including start and stop dates) 
• 
Subject’s condition upon completion of or withdrawal from the post market surveillance 
• 
Any other data required to substantiate data entered into the CRF 
 Case Report Form Completion  
Site research personnel trained on the PMS plan and CRF completion will perform the primary 
data collection clearly and accurately based on source-documented hospital and/or clinic chart 
reviews. The investigator will ensure accuracy, completeness, legibility, and timeliness of the 
data reported to the Sponsor on the CRFs and in all required reports. Sites will collect data on 
all subjects who sign an informed consent form until they experience an outcome or the 24 
month visit is completed. Only authorized site personnel will be permitted to enter the CRF data 
through the EDC system deployed by the Sponsor. The Sponsor will use an electronic audit trail 
to track any subsequent changes of the entered data. 
 Record Retention 
The Sponsor and Investigator/Site will archive and retain all documents pertaining to the post 
market surveillance as per the applicable regulatory record retention requirements. The 
Investigator must obtain permission from Sponsor in writing before destroying or transferring 
control of any post market surveillance records. 

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12.0 ETHICAL CONSIDERATION 
 
 Institutional Review Board Approval 
The Principal Investigator at each investigational site will obtain IRB approval for the PMS plan 
and ICF/other written information provided to the patient prior to consenting and enrolling 
patients in this post market surveillance. The site must receive the approval letter prior to the 
start of this post market surveillance and provide a copy to the Sponsor.  
 
Sites will submit any amendments to the PMS plan as well as associated ICF changes to the 
IRB and written approval obtained prior to implementation, according to each institution’s IRB 
requirements.  
 
No changes will be made to the PMS plan or ICF or other written information provided to the 
patient without appropriate approvals, including IRB, the Sponsor, and the regulatory agencies 
(if applicable).  
 
Until the post market surveillance is completed, the Investigator will advise his/her IRB of the 
progress of this post market surveillance, per IRB requirements. Written approval must be 
obtained from the IRB yearly to continue the post market surveillance, or according to each 
institution’s IRB requirements.  
 
Sites will not perform any investigative procedures, other than those defined in this PMS plan, 
on the enrolled subjects without the written agreement of the IRB and the Sponsor. 
13.0 POST MARKET SURVEILLANCE CONCLUSION 
The post market surveillance will be concluded when: 
• 
All sites are closed, AND 
• 
The final report has been provided to investigators or the Sponsor has provided formal 
documentation of post market surveillance closure. 
14.0 PUBLICATION POLICY 
The data and results from the post market surveillance are the sole property of the Sponsor. 
The Sponsor shall have the right to access and use all data and results generated during the 
post market surveillance. The Investigators will not use this post market surveillance-related 
data without the written consent of the Sponsor for any purpose other than for post market 
surveillance completion or for generation of publication materials, as referenced in the Clinical 
Trial Agreement. Single-center results are not allowed to be published or presented before the 
multi-center results. The Sponsor must review and approve any proposals for publications or 
presentations by the investigators in a timely manner in compliance with the Sponsor’s 
publication policy set forth in the Clinical Trial Agreement. 

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The Sponsor will be responsible for determining whether to register the post market surveillance 
on www.clinicaltrials.gov, in accordance with the International Committee of Medical Journal 
Editors guidelines, or any other applicable guidelines. In the event the Sponsor determines that 
the post market surveillance should be registered, the Sponsor shall be responsible for any 
such registration and results posting as required by the ClinicalTrials.gov website. Institution 
and/or Principal Investigator(s) shall not take any action to register the post market surveillance.  
15.0 RISK ANALYSIS 
 
 Anticipated Clinical Benefits 
In addition to improved functional status and quality of life, advanced heart failure patients may 
experience the following clinical benefits from use of the HM3 LVAD as compared to the 
HeartMate II LVAD11: 
1. improved survival free from stroke of any type or severity 
2. significantly lower risk of pump thrombosis 
3. lower risk of need for reoperation for pump replacement 
4. a lower risk of rehospitalization and device malfunction 
 Foreseeable Adverse Events and Anticipated Adverse Device Effects 
Risks associated with the specified device and procedure, together with their likely incidence, 
are described in Appendix IV.   
 Residual Risks Associated with the Device Under Investigation, as 
Identified in the Risk Management Report / Risk Analysis Report 
Risk analysis of the HM3 device has been performed in accordance with Abbott’s risk 
management and mitigation process, demonstrating systematic identification of hazards 
associated with the design and use of this device. Based upon bench testing and prior Abbott 
sponsored clinical study data, all risks have been mitigated as far as possible through 
application of risk controls documented in the risk management file. The overall risk benefit 
analysis concludes that the risks are outweighed by the benefits.  
Residual risks are likewise disclosed in the IFU in the form of clear instructions of what actions 
to take or to avoid, in order to avoid a hazardous situation of harm from occurring (contra-
indications, warnings, and precautions). The anticipated AEs disclosed in the IFU (and PMS 
plan Appendix IV) provide further information to enable the user, and potentially the patient, to 
make an informed decision that weights the residual risk against the benefit of using the device. 
 Risks Associated with Participation in this Post Market Surveillance  
All anticipated adverse events with the HM3 and the implant procedure are disclosed in 
Appendix IV. All the Study assessments (listed in Tables 1-4) are standard of care and would be 
performed even if the patient is not enrolled in this post market surveillance study.  

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 Steps Taken to Control or Mitigate Risks  
In-depth recommendations, special precautions and instructions regarding subject selection, 
device handling, physician training, device placement and system removal are included in the 
IFU. Mitigations and treatment for all adverse events will be performed per the current practice 
standards/standards of care as determined by the Investigator. 
 
Device Design 
The HM3 has several features to mitigate the risks to the patients including, but not limited to 
the following: 
• 
Alarms audibly and visibly indicate problems, such as low flow, to the patients, when 
appropriate. The alarms are also modulated in duration depending on the severity of the 
problem (Hazard vs. Advisory alarms). 
• 
The power cables (i.e. driveline) have been designed to be difficult to unintentionally 
disconnect. 
• 
The device was designed to be in compliance with international regulations on fire and 
shock hazards, biocompatibility, electromagnetic emissions and interference, and 
sterilization. These are outlined in the IFU. 
• 
The IFU for the HM3 describes the validated implant technique. 
• 
The LVAS is supplied with additional accessories to facilitate activities of daily living (e.g. 
shower bag) and the proper use of the device for different scenarios is explained in the 
IFU. 
• 
The IFU has checklists of items that need to be checked periodically to ensure proper 
device function and to identify problems before they become critical.   
• 
The HM3 LVAD has wide blood-flow paths and an artificial pulse feature to prevent 
stasis within the pump and thereby minimize the risk of thrombus formation. 
• 
The HM3 LVAD has no mechanical bearings, which minimizes the damage to the 
components of the blood when flowing through the pump.  
• 
The driveline cable was made modular via an inline connector to be able to replace the 
external segment without having to replace the entire system, thereby obviating pump 
exchange for driveline damage on the Controller side of the inline connector.  
• 
Where appropriate, blood contacting surfaces have been texturized to prevent the 
formation of clots.  
Please refer to the IFU for further information on the safety features of the HM3 LVAS. 
Investigator Selection and Training:  
It is also stated in the IFU that the devices can only be used by physicians who have received 
appropriate training on the proper use of the device. This statement is interpreted to mean that 
the physician users must complete Sponsor-provided HM3 training prior to clinical use and are 
expected to be aware of the known and foreseeable safety risks associated with the use of the 
devices including the surgical and/or non-surgical treatment of these conditions. Emergency 
surgical back-up should be available as per the institution’s standard procedures. Cases may be 
supported by Abbott field personnel. 
 
Ensuring Strict Adherence to the PMS plan 

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The post market surveillance will be carefully monitored by the Sponsor monitor (or designee) to 
ensure adherence to the PMS plan.  Adverse events and device deficiencies will be reported to 
the Sponsor/designee and will be monitored internally for safety surveillance purposes.  
 
Study Participation Risk Mitigation 
Subject risk from participation will be mitigated by ensuring that only experienced LVAD 
personnel will be involved in the care of research subjects. In addition to providing local product 
specific IFU, staff involved in this post market surveillance study will have undergone product 
and PMS plan training prior to initiating study-related activities, and all subjects will be closely 
monitored throughout the surveillance period at pre-specified time points to assess their clinical 
status. 
Specific information applicable to this PMS are listed below. 
• 
It is suggested that patients possess a minimum 5th grade educational level. 
• 
All users, including clinicians, patients, and caregivers, will be trained on HM3 system 
operation and safety before use. 
• 
Clinical procedures, including adjustments to LVAS settings, should be conducted under 
the direction of the prescribing physician (Authorized Personnel) only. 
 Risk to Benefit Rationale 
Participation in this post market surveillance study does not have any additional benefits or risks 
beyond what a patient may otherwise experience with the approved HM3 LVAS. However, this 
PMS will allow the collection of country specific data to incorporate within the continuing Risk 
Management activities of the Sponsor.   
 
 

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APPENDIX I: ABBREVIATIONS AND ACRONYMS 
Abbreviation 
Term 
ACEi 
Angiotensin Converting Enzyme inhibitor 
AE 
Adverse Event 
AI 
Aortic Insufficiency 
ALT 
Alanine Aminotransferase 
ARB 
Angiotensin II Receptor Blockers 
AST 
Aspartate Aminotransferase 
BTC 
Bridge-to-Candidacy 
BTT 
Bridge-to-Transplant 
CABG 
Coronary Artery Bypass Graft 
CI 
Cardiac Index 
CK 
Creatinine Kinase 
CK-MB 
Creatinine Kinase Muscle/Brain 
CNS 
Central Nervous System 
CO 
Cardiac Output 
CPB 
Cardiopulmonary Bypass 
CRF 
Case Report Form 
CT 
Computed Tomography 
CVP 
Central Venous Pressure 
DMP 
Data Management Plan 
DT 
Destination Therapy 
EDC 
Electronic Data Capture 
EPPY 
Events Per Patient Year 
eGFR 
Estimated Glomerular Filtration Rate 
FDA 
Food and Drug Administration 
GI 
Gastrointestinal 
HIE 
Hypoxic-ischemic injury 
HM3 
HeartMate 3 
ICF 
Informed Consent Form 
ICH 
Intracranial Hemorrhage 
IFU 
Instructions for Use 
INR 
International Normalized Ratio 
INTERMACS 
Interagency Registry for Mechanically Assisted Circulatory Support 
IRB 
Institutional Review Board 
LA 
Left Atrium 
LAA 
Left Atrial Appendage 
LDH 
Lactate dehydrogenase 

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Abbreviation 
Term 
LV 
Left Ventricle 
LVAD 
Left Ventricular Assist Device 
LVAS 
Left Ventricular Assist System 
LVEDD 
Left Ventricular End Diastolic Diameter 
LVEF 
Left Ventricular Ejection Fraction 
LVESD 
Left Ventricular End Systolic Diameter 
MCS 
Mechanical Circulatory Support 
MCSD 
Mechanical Circulatory Support Device 
MI 
Myocardial Infarction 
MOMENTUM3 Multi-center Study of MagLev Technology in Patients Undergoing 
MCS Therapy With HeartMate 3™ IDE Study 
MR 
Mitral Regurgitation 
MRI 
Magnetic Resonance Imaging 
MRS 
Modified Rankin Score 
MFDS 
Ministry of Food and Drug Safety 
NYHA 
New York Heart Association 
PAD 
Diastolic Pulmonary Artery Pressure 
PAS 
Systolic Pulmonary Artery Pressure 
PAM 
Mean Pulmonary Artery Pressure 
PMS 
Post Market Surveillance 
PR 
Pulmonary Regurgitation 
PRBC 
Packed Red Blood Cells 
PCWP 
Pulmonary Capillary Wedge Pressure 
RAP 
Right Atrial Pressure 
RHF 
Right Heart Failure 
RVAD 
Right Ventricular Assist Device 
SAE 
Serious Adverse Event 
SOC 
Standard of Care 
TE 
Thromboembolism 
tPA 
Tissue Plasminogen Activator 
TR 
Tricuspid Regurgitation 
UNOS 
United Network for Organ Sharing 
VAD 
Ventricular Assist Device 
VT 
Ventricular Tachycardia 
 
 
 

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APPENDIX II: DEFINITIONS 
ADVERSE EVENTS 
 
1. Bleeding 
An episode of SUSPECTED INTERNAL OR EXTERNAL BLEEDING that results in one or more 
of the following: 
a. Death, 
b. Reoperation, 
c. Hospitalization, 
d. Transfusion of red blood cells as follows: 
 If transfusion is selected, then apply the following rules:  
During first 7 days Post-implant 
• 
≥ 50 kg: ≥ 4U packed red blood cells (PRBC) within any 24 hour period during first 7 
days post-implant. 
• 
<50 kg: ≥20 cc/kg packed red blood cells (PRBC) within any 24 hour period during the 
first 7 days post-implant 
After 7 days Post-implant* 
• 
Any transfusion of packed red blood cells (PRBC) after 7 days following implant with the 
investigator recording the number of units given.  (Record number of units given per 24 
hour period). 
Note:  Hemorrhagic stroke is considered a neurological event and not as a separate bleeding 
event. 
*Any transfusion of ≥ 2U packed red blood cells (PRBC) after 7 days following implant will be 
considered a serious bleed 
 
2. Cardiac Arrhythmias 
Any documented arrhythmia that results in clinical compromise (e.g., diminished VAD flow, 
oliguria, pre-syncope or syncope) that requires hospitalization or occurs during a hospital stay.  
Cardiac arrhythmias are classified as 1 of 2 types: 
1) Sustained ventricular arrhythmia requiring defibrillation or cardioversion. 
2) Sustained supraventricular arrhythmia requiring drug treatment or cardioversion. 
 
3. Pericardial Fluid Collection 
Accumulation of fluid or clot in the pericardial space that requires surgical intervention or 
percutaneous catheter drainage.  This event will be subdivided into those with clinical signs of 
tamponade (e.g. increased central venous pressure and decreased cardiac/VAD output) and 
those without signs of tamponade. 
 
4. Device Thrombosis 
Device thrombosis is an event in which the pump or its conduits contain a thrombus that results 
in or could potentially induce circulatory failure. Suspected device thrombus is an event in which 

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clinical or MCSD parameters suggest thrombus on the blood contacting components of the 
pump, cannulae, or grafts. Signs and symptoms should include at least 2 of the 3 following 
criteria: 
• 
Presence of hemolysis 
• 
Worsening heart failure or inability to decompress the left ventricle 
• 
Abnormal pump parameters 
Suspected pump thrombus should be accompanied by 1 or more of the following events or 
interventions: 
• 
Treatment with intravenous anticoagulation (e.g., heparin), intravenous thrombolytics 
(e.g., tPA), or intravenous antiplatelet therapy (e.g., eptifibatide, tirofiban) 
• 
Pump replacement 
• 
Pump explant 
• 
Urgent transplant (UNOS status 1A) 
• 
Stroke 
• 
Arterial non-CNS thromboembolism 
• 
Death 
Confirmed device thrombus is an event in which thrombus is confirmed by Abbott returned 
product analysis to be found within the blood contacting surfaces of device inflow cannula or 
outflow conduit or grafts. This can also be reported via direct visual inspection or by 
incontrovertible contrast radiographic evidence or by the absence of an appropriate Doppler 
flow signal that results in or could potentially induce circulatory failure or result in 
thromboembolism. 
 
5. Hemolysis* 
A plasma-free hemoglobin value that is greater than 40 mg/dl, concomitant with a rise in serum 
LDH above three times the upper limit of normal, in association with clinical signs associated 
with hemolysis (e.g., anemia, low hematocrit, hyperbilirubinemia) occurring after the first 72 
hours post-implant.  
*Hemolysis in the presence of worsening heart failure or inability to decompress the left ventricle 
or abnormal pump parameters should be reported as suspected device thrombosis, not as 
hemolysis  
 
6. Hepatic Dysfunction 
An increase in any two of the following hepatic laboratory values (total bilirubin, aspartate 
aminotransferase/AST and alanine aminotransferease/ALT) to a level greater than three times 
the upper limit of normal for the hospital, beyond 14 days post-implant (or if hepatic dysfunction 
is the primary cause of death).   
 
7. Hypertension 
Blood pressure elevation of a mean arterial pressure greater than 110 mm Hg, despite anti-
hypertensive therapy.    

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8. Major Infection 
A clinical infection accompanied by pain, fever, drainage and/or leukocytosis that is treated by 
anti-microbial agents (non-prophylactic).  A positive culture from the infected site or organ 
should be present unless strong clinical evidence indicates the need for treatment despite 
negative cultures.  The general categories of infection are listed below: 
Localized Non-Device Infection 
Infection localized to any organ system or region (e.g. mediastinitis) without evidence of 
systemic involvement (see sepsis definition), ascertained by standard clinical methods and 
either associated with evidence of bacterial, viral, fungal or protozoal infection, and/or requiring 
empirical treatment.  
Percutaneous Site and/or Pocket Infection 
A positive culture from the skin and/or tissue surrounding the drive line or from the tissue 
surrounding the external housing of a pump implanted within the body, coupled with the need to 
treat with antimicrobial therapy, when there is clinical evidence of infection such as pain, fever, 
drainage, or leukocytosis. 
Internal Pump Component, Inflow or Outflow Tract Infection 
Infection of blood-contacting surfaces of the LVAD documented by positive site culture. 
Sepsis 
Evidence of systemic involvement by infection, manifested by positive blood cultures and/or 
hypotension. 
 
9. Myocardial Infarction 
Two categories of myocardial infarction will be identified: 
Peri-Operative Myocardial Infarction 
The clinical suspicion of myocardial infarction together with CK-MB or Troponin > 10 times the 
local hospital upper limits of normal, found within 7 days following VAD implant together with 
ECG findings consistent with acute myocardial infarction.  (This definition uses the higher 
suggested limit for serum markers due to apical coring at the time of VAD placement, and does 
not use wall motion changes because the apical sewing ring inherently creates new wall motion 
abnormalities.)  
Non-Perioperative Myocardial Infarction 
The presence at > 7 days post-implant of two of the following three criteria:   
a) Chest pain which is characteristic of myocardial ischemia,  
b) ECG with a pattern or changes consistent with a myocardial infarction, and  
c) Troponin or CK (measured by standard clinical pathology/laboratory medicine methods) 
greater than the normal range for the local hospital with positive MB fraction (≥ 3% total CK).  

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This should be accompanied by a new regional LV or RV wall motion abnormality on a 
myocardial imaging study. 
 
10. Neurologic Dysfunction 
Any new, temporary or permanent, focal or global neurological deficit, ascertained by a standard 
neurological history and examination administered by a neurologist or other qualified physician 
and documented with appropriate diagnostic tests and consultation note; or an abnormality 
identified by surveillance neuroimaging. The examining physician will classify the event as 
defined below:  
• 
Transient ischemic attack*, defined as an acute transient neurological deficit conforming 
anatomically to arterial distribution cerebral ischemia, which resolves in < 24 hours and 
is associated with no infarction on brain imaging (head CT performed >24 hours after 
symptom onset; or MRI) 
• 
Ischemic Stroke*: a new acute neurologic deficit of any duration associated with acute 
infarction on imaging corresponding anatomically to the clinical deficit, or a clinically 
covert ischemic stroke seen by surveillance imaging, without clinical findings of stroke or 
at the time of event recognition. 
• 
Hemorrhagic Stroke*: a new acute neurologic deficit attributable to intracranial 
hemorrhage (ICH), or a clinically covert ICH seen by surveillance imaging, without 
clinical findings of ICH at the time of event recognition. 
• 
Encephalopathy: Acute new encephalopathy** due to hypoxic-ischemic injury (HIE), or 
other causes, manifest as clinically evident signs or symptoms, or subclinical 
electrographic seizures found by complete neurological diagnostic evaluation to be 
attributable to acute global or focal hypoxic, or ischemic brain injury not meeting one of 
ischemic stroke or ICH events as defined above. 
• 
Seizure of any kind 
• 
Other neurological event (non-CNS event): examples include neuro muscular 
dysfunction or critical care neuropathy 
 
*Modified Rankin Score will be used to classify the severity of all strokes 
**Acute encephalopathy is a sign or symptom of some underlying cerebral disorder and is 
manifest as depressed consciousness with or without any associated new global or multifocal 
neurologic deficits in cranial nerve, motor, sensory, reflexes and cerebellar function. 
 
11. Psychiatric Episode 
Disturbance in thinking, emotion or behavior that causes substantial impairment in functioning or 
marked subjective distress requiring intervention.  Intervention is the addition of new psychiatric 
medication or hospitalization.  Suicide is included in this definition. 
 
12. Renal Dysfunction 
Two categories of renal dysfunction will be identified: 

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Acute Renal Dysfunction 
Abnormal kidney function requiring dialysis (including hemofiltration) in Subjects who did not 
require this procedure prior to implant, or a rise in serum creatinine of greater than 3 times 
baseline or greater than 5 mg/dL sustained for over 48 hours. 
Chronic Renal Dysfunction 
An increase in serum creatinine of 2 mg/dl or greater above baseline, or requirement for 
hemodialysis sustained for at least 90 days. 
 
13. Respiratory Failure 
Impairment of respiratory function requiring reintubation, tracheostomy or (the inability to 
discontinue ventilatory support within six days (144 hours) post-VAD implant.  This excludes 
intubation for reoperation or temporary intubation for diagnostic or therapeutic procedures. 
 
14. Right Heart Failure 
Symptoms and signs of persistent right ventricular dysfunction requiring RVAD implantation or 
requiring inhaled nitric oxide or inotropic therapy for a duration of more than 1 week at any time 
after LVAD implantation. 
 
15. Arterial Non-CNS Thromboembolism 
An acute systemic arterial perfusion deficit in any non-cerebrovascular organ system due to 
thromboembolism confirmed by one or more of the following:  
• 
Standard clinical and laboratory testing 
• 
Operative findings 
• 
Autopsy findings 
 
This definition excludes neurological events. 
 
16. Venous Thromboembolism Event 
Evidence of venous thromboembolic event (e.g. deep vein thrombosis, pulmonary embolism) by 
standard clinical and laboratory testing.  
 
17. Wound Dehiscence 
Disruption of the exposed surfaces of a surgical incision, excluding infectious etiology, and 
requiring surgical repair. 
 
18. Other 
An event that causes clinically relevant changes in the Subject’s health (e.g. cancer). 
 
 

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MODIFIED RANKIN SCORE 
 
 
Score 
Definition 
0 
No observed neurological symptoms  
1 
No significant neurological disability despite symptoms; able to carry 
out all usual duties and activities  
2 
Slight neurological disability; unable to carry out all previous activities, 
but able to look after own affairs without assistance  
3 
Moderate neurological disability; requiring some help, but able to walk 
without assistance  
4 
Moderate severe neurological disability; unable to walk without 
assistance and unable to attend to own bodily needs without 
assistance  
5 
Severe neurological disability; bedridden, incontinent and requiring 
constant nursing care and attention as a result of a neurological deficit  
6 
Death  
 
 

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DEVICE MALFUNCTIONS 
A Device Malfunction occurs when any component of the MCS system ceased to operate to its 
designated performance specifications or otherwise fails to perform as intended. Performance 
specifications include all claims made in the Instructions for Use.  
Internal Component Malfunction: Malfunction of any device system component that is implanted 
within the patient. A malfunction to these components may require further surgery to repair or 
replace.  
External Component Malfunction: Malfunction of a device system component that is used 
external to the patient and can be replaced or repaired without the need for further surgery. 
 

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NEW YORK HEART ASSOCIATION (NYHA) CLASSIFICATION 
 
 
NYHA Classification 
Definition 
I 
Cardiac disease without resulting limitations of physical activity. 
Ordinary physical activity does not cause undue fatigue, palpitations, 
dyspnea or anginal pain. 
II 
Cardiac disease resulting in slight limitation of physical activity. 
Subjects are comfortable at rest. Ordinary physical activity results in 
fatigue, palpitation, dyspnea or anginal pain. 
IIIA 
Cardiac disease resulting in marked limitations of physical activity. 
Subjects are comfortable at rest. Less than ordinary physical activity 
causes fatigue, palpitation, dyspnea, or anginal pain. 
IIIB 
Cardiac disease resulting in marked limitations of physical activity. 
Subjects are comfortable at rest. Mild physical activity causes fatigue, 
palpitation, dyspnea, or anginal pain. 
IV* 
Cardiac disease resulting in inability to carry on any physical activity 
without discomfort. Symptoms of cardiac insufficiency or of the anginal 
syndrome may be present even at rest. If any physical activity is 
undertaken, discomfort is increased. 
 
*For all post-enrollment NYHA assessments, any patient who is inotrope dependent will be 
considered NYHA Class IV.

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INTERMACS PROFILE 
 
INTERMACS 
Profile* 
Definition 
1 
Critical cardiogenic shock describes a patient who is “crashing and burning”, in which a patient 
has life-threatening hypotension and rapidly escalating inotropic pressor support, with critical 
organ hypoperfusion often confirmed by worsening acidosis and lactate levels.  
2 
Progressive decline describes a patient who has been demonstrated “dependent” on inotropic 
support but nonetheless shows signs of continuing deterioration in nutrition, renal function, 
fluid retention, or other major status indicator. Patient profile 2 can also describe a patient with 
refractory volume overload, perhaps with evidence of impaired perfusion, in whom inotropic 
infusions cannot be maintained due to tachyarrhythmias, clinical ischemia, or other 
intolerance.  
3 
Stable but inotrope dependent describes a patient who is clinically stable on mild-moderate 
doses of intravenous inotropes (or has a temporary circulatory support device) after repeated 
documentation of failure to wean without symptomatic hypotension, worsening symptoms, or 
progressive organ dysfunction (usually renal). It is critical to monitor nutrition, renal function, 
fluid balance, and overall status carefully in order to distinguish between a patient who is truly 
stable at Patient Profile 3 and a patient who has unappreciated decline rendering this person a 
Patient Profile 2. This patient may be either at home or in the hospital.  
4 
Resting symptoms describes a patient who is at home on oral therapy but frequently has 
symptoms of congestion at rest or with ADL. He or she may have orthopnea, shortness of 
breath during ADL such as dressing or bathing, gastrointestinal symptoms (abdominal 
discomfort, nausea, poor appetite), disabling ascites or severe lower extremity edema. This 
patient should be carefully considered for more intensive management and surveillance 
programs, by which some may be recognized to have poor compliance that would compromise 
outcomes with any therapy.  
5 
Exertion Intolerant describes a patient who is comfortable at rest but unable to engage in any 
activity, living predominantly within the house or housebound. This patient has no congestive 
symptoms, but may have chronically elevated volume status, frequently with renal dysfunction, 
and may be characterized as exercise intolerant.  
6 
Exertion Limited also describes a patient who is comfortable at rest without evidence of fluid 
overload, but who is able to do some mild activity. Activities of daily living are comfortable and 
minor activities outside the home such as visiting friends or going to a restaurant can be 
performed, but fatigue results within a few minutes of any meaningful physical exertion. This 
patient has occasional episodes of worsening symptoms and is likely to have had a 
hospitalization for heart failure within the past year.  
7 
Advanced NYHA Class 3 describes a patient who is clinically stable with a reasonable level of 
comfortable activity, despite history of previous decompensation that is not recent. This patient 
is usually able to walk more than a block. Any decompensation requiring intravenous diuretics 
or hospitalization within the previous month should make this person a Patient Profile 6 or 
lower.   
 
 
 
 

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6-MINUTE WALK TEST 
 
Purpose 
The purpose of the 6-Minute Hallway Walk test (6MWT) is to walk as far as possible for 6-minutes, 
without running or jogging, as a way of measuring functional status. 
 
Preparing for the test 
1. Establish a 30-meter walking course in an enclosed corridor, preferably free of distractions and close 
to a wall so that if needed, the Subject may rest against it during the test (note: a treadmill is not an 
acceptable alternate method for this PMS).   
2. Mark the course at 3-meter intervals using a method unnoticeable to the Subject.   
3. Place noticeable markers at either end of the 30-meter course to indicate the turnaround points.  
4. The distance covered during the preceding walk test will not be revealed to the Subject during the 
PMS.  
5. A warm up prior to the test should not be performed. 
 
Explaining the test procedure to the Subject 
1. Clearly explain to the Subject what is required of him/her using the following instructions verbatim: 
THE PURPOSE OF THIS TEST IS TO WALK AS FAR AS POSSIBLE FOR SIX-MINUTES.  YOU 
WILL START FROM THIS POINT AND FOLLOW THE HALLWAY TO THE MARKER AT THE END, 
THEN TURN AROUND AND WALK BACK.  WHEN YOU ARRIVE BACK AT THE STARTING 
POINT, YOU WILL GO BACK AND FORTH AGAIN.  YOU WILL GO BACK AND FORTH AS MANY 
TIMES AS YOU CAN IN THE SIX-MINUTE PERIOD.  IF YOU NEED TO, YOU ARE PERMITTED 
TO SLOW DOWN, TO STOP, AND TO REST AS NECESSARY.  YOU MAY LEAN AGAINST THE 
WALL WHILE RESTING, BUT RESUME WALKING AS SOON AS YOU ARE ABLE.  HOWEVER, 
THE MOST IMPORTANT THING ABOUT THE TEST IS THAT YOU COVER AS MUCH GROUND 
AS YOU POSSIBLY CAN DURING THE SIX MINUTES.  I WILL KEEP TRACK OF THE NUMBER 
OF LAPS YOU COMPLETE AND I WILL LET YOU KNOW WHEN THE SIX MINUTES ARE UP.  
WHEN I SAY STOP, PLEASE STAND RIGHT WHERE YOU ARE. 
DO YOU HAVE ANY QUESTIONS ABOUT THE TEST? 
PLEASE EXPLAIN TO ME WHAT YOU ARE GOING TO DO. 
 
2. The Subject will re-state the instructions.  If the Subject does not seem to understand, repeat the 
entire instructions. 
 
Conducting the test 
1. Position the Subject at the starting line.   
2. Repeat the sentence: 
THE MOST IMPORTANT THING ABOUT THE TEST IS THAT YOU COVER AS MUCH 
GROUND AS YOU POSSIBLY CAN DURING THE SIX MINUTES. 
ARE YOU READY?  
START NOW, OR WHENEVER YOU ARE READY.   
 
3. Start the timer as soon as the Subject takes the first step.   

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4. During the test, the walking pace of the Subject should not be influenced.  The test supervisor 
must walk behind the Subject – do not walk with, rush up behind, or rush past the Subject. 
5. Each time the Subject returns to the starting line, record the lap. 
6. While walking, encourage the Subject at one-minute intervals with the following phrases: 
 
1 minute: 
YOU ARE DOING WELL.  YOU HAVE 5 MINUTES TO GO.  
2 minutes: 
KEEP UP THE GOOD WORK.  YOU HAVE 4 MINUTES TO GO. 
3 minutes: 
YOU ARE DOING WELL.  YOU ARE HALFWAY DONE. 
4 minutes: 
KEEP UP THE GOOD WORK.  YOU HAVE ONLY 2 MINUTES LEFT. 
5 minutes: 
YOU ARE DOING WELL.  YOU HAVE ONLY ONE MINUTE TO GO. 
 
7. The Subject should be spoken to only during the 1-minute encouragements; no response should 
be made to the Subject’s questions about the time and distance elapsed.   
a. If the Subject is not concentrating on the walking, the Subject can be reminded at a 1-minute 
mark: 
THIS IS A WALKING TEST, TALKING WILL UTILIZE YOUR ENERGY RESERVE AND 
INTERFERE WITH YOUR PERFORMANCE. 
When only 15 seconds remain, state: 
IN A MOMENT I AM GOING TO TELL YOU TO STOP.  WHEN I DO, STOP RIGHT WHERE 
YOU ARE AND I WILL COME TO YOU.   
 
8. When the timer reads 6-minutes, instruct the Subject to STOP and walk over to him/her. Consider 
bringing a chair if the Subject appears exhausted.  Mark the spot where the Subject stopped.   
  
If the Subject wishes to stop walking during the test 
If the Subject is slowing down and expresses that he/she wants to pause, keep the timer running 
and state: 
REMEMBER, IF YOU NEED TO, YOU MAY LEAN AGAINST THE WALL UNTIL YOU CAN 
CONTINUE WALKING AGAIN. 
 
If the Subject wishes to stop before the 6-minutes are complete and refuses to continue (or you 
decide that he/she should not continue), provide a chair for the Subject to sit on and discontinue 
the test.  Record the distance completed, the time the test was stopped and the reason for pre-
maturely stopping.   
 
Immediately after the test 
1. Total the number of completed laps and add the additional distance covered in the final partial 
lap.  Record the distance walked to the nearest meter. 
2. Observe the Subject sitting in a chair for at least 10 minutes after the test is completed.  
 
 

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APPENDIX III: CONTACT INFORMATION 
Contact information for each participating clinical site is available under separate cover by contacting the 
Sponsor at: 
 
Evonne Poon 
Clinical Project Manager 
3 Fraser Street #23-28 
DUO Tower 
Singapore 189352  
Ph: +65 6914 8433  
Email: evonnesueyin.poon@abbott.com  
 
 

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APPENDIX IV: ANTICIPATED ADVERSE EVENTS 
1. Incidence of anticipated adverse events with the HM3, HM2 and HVAD at 2 years from Pivotal 
Trials and Real-World Data from the INTERMACS Database 
 
Anticipated  
Adverse Events 
% of Subjects with Events 
HEARTMATE 3 
HEARTMATE II 
HVAD 
All-cause Death 
HM3 CE MARK5: 24% 
MOMENTUM 311: 19% 
INTERMACS 201912: 
16.0% 
ENDURANCE: 32.2% 
MOMENTUM 311: 19.7% 
INTERMACS 2019: 28.0% 
ENDURANCE13: 39.2% 
INTERMACS 2019: 
28.0% 
Bleeding 
HM3 CE MARK: 50% 
MOMENTUM 3: 43.7% 
ENDURANCE: 60.4% 
MOMENTUM 3: 55.0% 
ENDURANCE: 60.1% 
Stroke  
HM3 CE MARK: 24% 
MOMENTUM 3: 9.9% 
INTERMACS 2019: 7.0% 
ENDURANCE: 12.1% 
MOMENTUM 3: 19.4% 
INTERMACS 2019: 18% 
ENDURANCE: 29.7% 
INTERMACS 2019: 
22.0% 
Infection 
INTERMACS 2019: 41.0% 
INTERMACS 2019: 51.0% 
INTERMACS 2019: 
55.0% 
Driveline 
HM3 CE MARK: 24% 
MOMENTUM 3: 23.3% 
ENDURANCE: 15.4% 
MOMENTUM 3: 19.4% 
ENDURANCE: 19.6% 
Sepsis 
HM3 CE MARK: 22% 
MOMENTUM 3: 15.1% 
ENDURANCE: 15.4% 
MOMENTUM 3: 14.9% 
ENDURANCE: 23.6% 
Suspected/Confirmed PT 
HM3 CE MARK: 0.0% 
MOMENTUM 3: 1.4% 
ENDURANCE: 10.7%a 
MOMENTUM 3: 13.9% 
ENDURANCE: 6.4% a 
Cardiac Arrhythmia 
HM3 CE MARK b: 34% 
MOMENTUM 3: 35.9% 
ENDURANCE: 40.9% 
MOMENTUM 3: 41.0% 
ENDURANCE: 37.8% 
 
Right Heart Failure 
HM3 CE MARK: 14% 
MOMENTUM 3: 34.2% 
INTERMACS 2019: 37.0% 
ENDURANCE: 26.8% 
MOMENTUM 3: 28.3% 
INTERMACS 2019: 34.0% 
ENDURANCE: 38.5% 
INTERMACS 2019: 46% 
Renal Dysfunction 
HM3 CE MARK b: 10% 
MOMENTUM 3: 14.2% 
ENDURANCE: 12.1% 
MOMENTUM 3: 11.1% 
ENDURANCE: 14.9% 
 
Hepatic Dysfunction 
HM3 CE MARK b: 2.0% 
MOMENTUM 3: 4.9% 
ENDURANCE: 8.1% 
MOMENTUM 3: 5.3% 
ENDURANCE: 4.7% 
 
Respiratory Failure 
HM3 CE MARK b: 16.0% 
MOMENTUM 3: 21.6% 
ENDURANCE: 25.5% 
MOMENTUM 3: 19.4% 
ENDURANCE: 29.1% 
 
Hypertension 
HM3 CE MARK b: 2.0% 
MOMENTUM 3 d: 8.2% 
ENDURANCE: 16.8% 
MOMENTUM 3 d: 9.3% 
ENDURANCE: 15.9% 
 
Pericardial Fluid 
Collection 
HM3 CE MARK b: 2.0% 
MOMENTUM 3 d: 4.9% 
ENDURANCE c: 6.0% 
MOMENTUM 3 d: 8.7% 
ENDURANCE c: 2.7% 
 
MI 
HM3 CE MARK b: 0.0% 
MOMENTUM 3 d: 1.2% 
ENDURANCE c: 0% 
MOMENTUM 3 d: 1.0% 
ENDURANCE c: 1.4% 
 
Hemolysis 
HM3 CE MARK: 0.0% 
MOMENTUM 3 d: 1.2% 
ENDURANCE: 8.7% 
MOMENTUM 3 d: 1.6% 
ENDURANCE: 8.1% 
 

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Arterial Non-CNS TE 
HM3 CE MARK b: 0.0% 
MOMENTUM 3 d: 1.0% 
ENDURANCE: 6.7% 
MOMENTUM 3 d: 2.0% 
ENDURANCE: 6.1% 
 
Venous TE 
HM3 CE MARK b: 0.0% 
MOMENTUM 3 d: 3.9% 
ENDURANCE c: 3.4% 
MOMENTUM 3 d: 2.8% 
ENDURANCE c: 2.7% 
 
PT – pump thrombosis; TE – thromboembolic events; MI – myocardial infarction; Non-CNS – non central nervous system. 
 
Pivotal study sample size: HM3 CE MARK: 50 patients implanted with the HM3; MOMENTUM 3: 1028 (8 patients died post 
randomization; data reported are from 515 HM3 and 505 HM2 patients); ENDURANCE: 446 (1 patient did not receive either 
device; data reported are from 296 HVAD and 149 HM2 patients).  
 
a Pump thrombosis requiring pump exchange. 
 
b, c, d From clinicaltrials.gov (NCT02170363, NCT01166347 and NCT02224755). 
 
 
2. Device issues identified and addressed during MOMENTUM3 IDE study 
 
Outflow graft twist 
 
At the time this issue was identified, 35 of 5607 (0.62%) devices implanted worldwide were reported to 
have this issue. The outflow graft (OG) twist resulted in low blood flow and/or formation of thrombus 
within the OG. There were three deaths that were attributed to this issue. On May 22nd, 2018, the FDA 
categorized this as a Class I recall event. Analysis done by the Sponsor suggested that, over time, 
normal motion such as the heart beating, respiration and patient activity can cause small rotations 
between the OG bend relief component and the outflow graft metallic connector underneath. These 
forces, known as “in vivo loads”, are believed to cause the OG twisting. Additionally, it was determined 
that the twisting may occur more easily if the screw ring is not firmly hand tightened during implant. In 
response to the identification of this issue, initially a clip was designed to secure the OG to the pump 
housing and then later the pump housing design was modified to prevent the OG twist from occurring. 
   
HM3 Driveline Communication Fault 
On June 7, 2017, the Sponsor notified the MOMENTUM 3 DSMB chair and investigators of limited 
reports of errors in communication between the System Controller and pump of the HM3 LVAS.  The root 
cause of the errors was traced to manufacturing variances from a single supplier that could lead to 
crystallization within the pump electronics.   
The specifications and manufacturing processes for the HM3 pump have been updated to ensure this 
issue did not occur in future lots. In addition, the Sponsor retrieved potentially impacted HM3 implant kits 
from hospital shelves. The units that were removed from investigational sites were replaced with product 
not impacted by this field advisory. 
To date, there have been no adverse effects related to this issue; however, it may lead to frequent 
advisory alarms that may need to be silenced.  In the notification to investigators, the Sponsor provided 
recommendations for managing patients with advisory alarms.  The Sponsor has received 
acknowledgment forms from all investigators indicating that they were made aware of the issue and the 
associated recommendations. 
 
 

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APPENDIX V: CASE REPORT FORMS 
Final draft CRFs will be sent under a separate cover. 
 
 

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APPENDIX VI: INFORMED CONSENT FORM 
A template informed consent form will be provided under a separate cover. 
 
 
 
 

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APPENDIX VII: MONITORING PLAN 
A copy of the Monitoring Plan can be obtained upon request from the Sponsor Clinical Project Manager 
for the post market surveillance. 
 
 

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APPENDIX VIII: REVISION HISTORY 
This PMS plan may be amended as appropriate by the Sponsor. Rationale will be included with each 
amended version in the revision history table below. The version number and date of amendments will 
be documented. 
 
IRB and relevant Regulatory Authorities, if applicable, will be notified of amendments to the PMS plan. 
 
Amendment 
Number 
Version 
Date 
Details 
Rationale 
Not Applicable 
A 
02/DEC/2020 
First release of PMS plan 
NA 
 
 
 

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APPENDIX IX: PMS PLAN SUMMARY 
Post Market 
Surveillance 
Study Name and 
Number 
Hong Kong and Taiwan HM3 PMS 
CRD_1022 
Title 
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in 
Hong Kong and Taiwan 
Primary Objective 
The primary objective of this prospective, post-market surveillance study is to 
assess the use of the HM3 LVAS in the setting of Hong Kong and Taiwanese 
standard-of-care for advanced heart failure patients implanted with this device.  
Secondary objective of this PMS is to assess the adverse events occurring during 
the surveillance period.   
Assessments will include: 6-minute walk test, New York Heart Association heart 
failure severity classification, EQ-5D-5L quality of life questionnaire, rates of 
survival, transplant, pump explant or exchange, device malfunctions, reoperations, 
rehospitalizations and incidence of adverse events including, but not limited to, 
neurological dysfunction, bleeding, device thrombosis, and infection.  
Device Under 
Investigation 
HeartMate 3™ Left Ventricular Assist System  
Number of 
Subjects Required 
for Inclusion in 
Post market 
surveillance 
All consecutive patients at the participating sites with a planned HM3 implant, that 
meet the HM3 commercially approved labelling indications are eligible to 
participate in this PMS. We expect approximately 30 patients will be enrolled 
during the surveillance period. 
Post market 
surveillance 
Design 
Prospective, single arm, open-label, multi-center, post market surveillance study 
Subject Follow-up 
Surveillance visits will occur at:  
• 
Baseline/Enrollment (prior to HM3 implant) 
• 
HM3 Implant  
• 
Month 1 ± 7 days 
• 
Month 3 ± 30 days 
• 
Month 6 ± 30 days 
• 
Month 12 ± 30 days 
• 
Month 24 ± 60 days 
Note: 
− 
The follow-up visits are relative to the date of HM3 implant. 
− 
A month is defined as 30 days. 
− 
the patients will be followed until they experience an outcome or the 24 
month follow-up visit is completed, whichever comes first. 
 

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APPENDIX X: REFERENCES 
1 
Colombo, P. C. et al. Comprehensive Analysis of Stroke in the Long-Term Cohort of the 
MOMENTUM 3 Study. Circulation 139, 155-168, doi:10.1161/CIRCULATIONAHA.118.037231 
(2019). 
2 
Schmitt, F. et al. 3 Tesla MRI: successful results with higher field strengths. Der Radiologe 44, 
31-47 (2004). 
3 
Cleveland, J. C., Goldstein, D. J., Uriel, N., Mehra, M. R. & Investigators, M. Forward 
"MOMENTUM" in left ventricular assist systems: advanced engineering meets biology. Journal of 
thoracic disease 9, E653-E655, doi:10.21037/jtd.2017.06.72 (2017). 
4 
Bourque, K. et al. Design Rationale and Preclinical Evaluation of the HeartMate 3 Left Ventricular 
Assist System for Hemocompatibility. ASAIO J 62, 375-383, 
doi:10.1097/MAT.0000000000000388 (2016). 
5 
Schmitto, J. D. et al. Long-term evaluation of a fully magnetically levitated circulatory support 
device for advanced heart failure—two-year results from the HeartMate 3 CE Mark Study. 
European Journal of Heart Failure 21, 90-97, doi:10.1002/ejhf.1284 (2019). 
6 
Schmitto, J. D. et al. Long-term evaluation of a fully magnetically levitated circulatory support 
device for advanced heart failure-two-year results from the HeartMate 3 CE Mark Study. Eur J 
Heart Fail 21, 90-97, doi:10.1002/ejhf.1284 (2019). 
7 
Garbade, J. et al. Postmarket Experience With HeartMate 3 Left Ventricular Assist Device: 30-
Day Outcomes From the ELEVATE Registry. Ann Thorac Surg 107, 33-39, 
doi:10.1016/j.athoracsur.2018.07.092 (2019). 
8 
Heatley, G. et al. Clinical trial design and rationale of the Multicenter Study of MagLev 
Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 
(MOMENTUM 3) investigational device exemption clinical study protocol. J Heart Lung 
Transplant 35, 528-536, doi:10.1016/j.healun.2016.01.021 (2016). 
9 
Mehra, M. R. et al. A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure. 
The New England journal of medicine 376, 440-450, doi:10.1056/NEJMoa1610426 (2017). 
10 
Mehra, M. R. et al. Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart 
Failure. The New England journal of medicine 378, 1386-1395, doi:10.1056/NEJMoa1800866 
(2018). 
11 
Mehra, M. R. et al. A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report. 
The New England journal of medicine 380, 1618-1627, doi:10.1056/NEJMoa1900486 (2019). 
12 
Teuteberg, J. J. et al. The Society of Thoracic Surgeons Intermacs 2019 Annual Report: The 
Changing Landscape of Devices and Indications. Ann Thorac Surg 109, 649-660, 
doi:10.1016/j.athoracsur.2019.12.005 (2020). 
13 
Rogers, J. G. et al. Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure. The 
New England journal of medicine 376, 451-460, doi:10.1056/NEJMoa1602954 (2017). 
14 
Milano, C. A. et al. HVAD: The ENDURANCE Supplemental Trial. JACC Heart Fail 6, 792-802, 
doi:10.1016/j.jchf.2018.05.012 (2018).