MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT CAPTIVIA - FF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Model Number	VAMF3232C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/15/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name valiant captivia - cw; product id vamc3632c150tu (serial: (b)(6)); product type: 0180-aortic stent graft; implant date (b)(6) 2024; explant date brand name valiant captivia - cw; product id vamc3636c150tu (serial: (b)(6)); product type: 0180-aortic stent graft; implant date (b)(6) 2024; explant date 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.
Event or Problem Description
Valiant captivia stent grafts were implanted in the emergent endovascular treatment of a ruptured thoracic aneurysm.It was reported that during the procedure, the patient received open debranching and surgical graft repair followed immediately by e ndovascular stent graft implantation.The valiant captivia stent grafts deployed as expected.The patient coded and expired on the table at the conclusion of the surgical procedure.Per the physician, it is unknown what was the cause of the death and whether the devices or procedure contributed.

• Brand Name: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 20368956
• Report Number: 9612164-2024-04526
• Device Sequence Number: 6859741
• Product Code: MIH
• UDI-Device Identifier: 00643169346987
• UDI-Public: 00643169346987
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2024

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 Expiration Date: 01/01/2026
• Device Model Number: VAMF3232C150TU
• Device Catalogue Number: VAMF3232C150TU
• 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: 09/15/2024
• Initial Report FDA Received Date: 10/04/2024
• Date Device Manufactured: 01/02/2024
• 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: SEE H11...
• Outcome Attributed to Adverse Event: Death
• Patient Age: 49 YR
• Patient Sex: Male