MAUDE Adverse Event Report: COVIDIEN SURGICAL TRI-STAPLE 2.0; STAPLE, IMPLANTABLE

Model Number	SIG30AVM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a gastric bypass, the patient experienced staple line bleeding from the four reloads after firing.Five days after the procedure, blood in the stool was observed.The patient required extended hospitalization for five days and was admitted to the intensive care unit.No intervention was performed to address the staple line bleeding.
Additional Manufacturer Narrative
D10 concomitant product: egia60amt, egia60amt egia 60 artic med thick sulu (lot#p5c1345); egia45avm, egia45avm egia 45 artic vasc med sulu (lot#p5c1325); egia60avm, egia60avm egia 60 artic vasc med sulu (lot#p5d1081).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: TRI-STAPLE 2.0
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22922564
• Report Number: 1219930-2025-03825
• Device Sequence Number: 18430969
• Product Code: GDW
• UDI-Device Identifier: 10884521543669
• UDI-Public: (01)10884521543669(17)300131(10)N5B1411Y(20)03
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SIG30AVM
• Device Catalogue Number: SIG30AVM
• Device Lot Number: N5B1411Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/29/2025
• Date Device Manufactured: 02/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H11
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female