Medtronic Signia SDR Product Surveillance Registry

Study Overview
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Brief Summary
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The purpose of the registry is to confirm the safety and performance of the Signia™ Small Diameter Reload (SDR) when used in surgical procedures in a real-world setting in patients receiving surgery for indicated thoracic, abdominal, and pediatric applications, intraoperatively.

Official Title
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Medtronic Signia Small Diameter Reload Product Surveillance Registry

Conditions
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Minimally Invasive Surgical Procedures, Surgical Procedures, Operative

Intervention / Treatment
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* Other: N/A observational registry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements Patient has, or is intended to receive or be treated with, an eligible Medtronic product Patient is consented within the enrollment window of the therapy received, as applicable Exclusion Criteria: Patient who is, or is expected to be, inaccessible for follow-up Patient is excluded by local law Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the PSR results
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Thoracic Adult<br>Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients. | Other: N/A observational registry<br>* N/A observational registry<br>|
| Abdominal Adult<br>Use of Signia SDR for the transection of renal arteries and veins in adult patients. | Other: N/A observational registry<br>* N/A observational registry<br>|
| Abdominal Pediatric<br>Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients. | Other: N/A observational registry<br>* N/A observational registry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intraoperative hemostatic intervention |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of repeat hospital admission for primary procedure-related complications |  | 30 days | 
| Intraoperative assessments: Assessment of staple line integrity using a five-point Likert scale | Range from 1 (no bleeding) to 5 (significant bleeding requiring intervention) | 30 days | 
| Intraoperative assessments: Incidence of staple line bleeding (measured as > 50cc) |  | 30 days | 
| Intraoperative assessments: Additional intervention(s) to treat staple line failure | Additional interoperative interventions to treat staple line failure (Applying additional stapler reloads, Applying compression greater than what is considered typical, Over-sewing with suture, Placing clips, Use of energy, Use of seatbelt, Other) | 30 days | 
| Post-operative assessments: Additional intervention(s) to treat staple-line failure | Additional postoperative interventions to treat staple line failure (Applying additional stapler reloads, Applying compression greater than what is considered typical, Over-sewing with suture, Placing clips, Use of energy, Use of seatbelt, Other) | 30 days |