WARNING LETTER
SynCardia Systems LLC
MARCS-CMS 537226 —
April 03, 2018
Recipient:
SynCardia Systems LLC
United States
Issuing Office:
Los Angeles District Office
United States
Office of Medical Device and Radiological Health Operations
Division 3 West
19701 Fairchild
Irvine, CA 92612
WARNING LETTER
CMS #537226
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
April 3, 2018
Michael P. Garippa, President and CEO
SynCardia Systems, LLC
1992 E. Silverlake Road
Tucson, AZ 85713
Dear Mr. Garippa:
During an inspection of your firm located in Tuczon, AZ, from August 14 through August 18, 2017, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the SynCardia Temporary Total Artificial Heart (TAH-t) System. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
Our inspection revealed that your SynCardia Temporary Total Artificial Heart (TAH-t) System device is misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information regarding the device that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting. Significant deviations include, but are not limited to:
1.    Failure to report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).
For example, your SynCardia TAH-t post-approval study identified a patient (ID
(b)(4)
) with the cause of death listed as device malfunction. The male patient’s age was listed between 60-69 years with an implant date in January 2016 and death 1 month later. However, your firm has not yet submitted an MDR for the event that occurred in March 2016. Your firm’s response noted that it relies on its customers to provide reports of patient death associated with your firm’s devices. This is not adequate. As a manufacturer, your firm is responsible to evaluate each device associated event for reportability and accordingly submit a report within the 30-calendar day timeframe. Further, your firm failed to provide documentation that demonstrates that it made a reasonable effort to obtain additional information regarding the device associated event.
We reviewed your firm’s responses dated September 11, 2017 and October 10, 2017, as well as the emails dated (October 16 and 24, 2017) to the FDA 483 and conclude that the adequacy of your firm’s responses cannot be determined at this time. For example, your firm provided evidence of the revised procedures titled “Customer Experience Procedure,
(b)(4)
, Release Date September 22, 2017” and “Electronic Medical Device Reporting Procedure,
(b)(4)
, Release Date September 22, 2017” incorporating a process for identifying and evaluating an adverse event occurring without a customer complaint as potentially reportable to FDA. Also, your firm did not provide documentation or evidence of the implementation of corrective actions to ensure that all adverse events are handled as appropriately as required.
2.    Failure to adequately develop, maintain and implement written MDR procedures as required by 21 CFR 803.17.
For example, after reviewing your firm’s MDR procedure titled “Electronic Medical Device Reporting Procedure”,
(b)(4)
, no release date, the following issues were noted:
1.
There is no evidence that your firm’s MDR procedures have been implemented. For example, there is no effective or release date for the MDR procedure.
2.
Your firm’s MDR procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example, your procedure does not reference a process for identifying and evaluating adverse events occurring without a customer complaint as potentially reportable to FDA.
3.
Your firm’s MDR procedure does not describe how it will address documentation and record-keeping requirements, including documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable. For example, your firm became aware of a death in March of 2016 of a male patient (ID
(b)(4)
) and failed to file an MDR report. Further, your firm did not provide any documentation of why an MDR report was not submitted to the FDA.
We reviewed your firm’s responses dated September 11, 2017 and October 10, 2017, as well as the emails dated (October 16 and 24, 2017) to the FDA 483 and conclude that the adequacy of your firm’s response cannot be determined at this time. For example, your firm provided evidence of the revised MDR procedure titled “Electronic Medical Device Reporting Procedure,
(b)(4)
, Release Date September 22, 2017”, as well as training documentation. However, your firm has not provided evidence of retrospective review of adverse events as this corrective action is targeted for completion on December 1, 2017. Based on the submitted information, the issues noted above under 2(2) and 2(3) are still noted.
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, you may contact the Reportability Review Team by email at
ReportabilityReviewTeam@fda.hhs.gov
.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility.  It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.  The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.  Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
If you have any questions regarding any issues in this letter, please contact Compliance Officer Dr. Raymond W. Brullo, at (949) 608-2918 or at
raymond.brullo@fda.hhs.gov
. Your firm’s response to this letter should be sent to the following email address:
oradevices3firmresponse@fda.hhs.gov
. Refer to case #
(b)(4)
when replying.
Sincerely,
/S/
Shari J. Shambaugh
Program Division Director
Content current as of:
04/17/2018