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

Model Number	VAMF3636C200TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hematoma (1884); Pain (1994)
Date of Event	11/06/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
This is a system report.The section d information is for the primary device, which was in use with the following: brand name valiant captivia - cw; product id vamc3834c150tu (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 during the endovascular treatment of a 200mm thoracic aortic dissection.The patient was previously diagnosed with a type b dissection 2 months prior to the index procedure.During a prior hospitalization, the patient developed a bowel obstruction requiring surgical intervention.Following recovery, the patient underwent tevar.The index procedure went well, and the two valiant captivia stent grafts were implanted with no issues and the patent was discharged.8 days post index procedure the patient experienced extreme pain that disrupted sleep.Subsequent ct imaging revealed an ascending hematoma.Emergency intervention to repair the ascending aortic arch was performed the following the morning.The ascending arch was repaired however, the patient suffered cardiac arrest upon waking and could not be resuscitated, resulting in death 9 days post index procedure.Per the physician the cause of the ascending hematoma is undetermined.
Additional Manufacturer Narrative
The physician believes the patient had some sort connective tissue disease that was undiagnosed and believes that the patient's death was not related to the stent graft.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.
Additional Manufacturer Narrative
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: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• 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: 20734560
• Report Number: 9612164-2024-05435
• Device Sequence Number: 12886607
• Product Code: MIH
• UDI-Device Identifier: 00643169346567
• UDI-Public: 00643169346567
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup,Followup
• Report Date (Section B): 01/31/2025

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 Expiration Date: 04/05/2026
• Device Model Number: VAMF3636C200TU
• Device Catalogue Number: VAMF3636C200TU
• 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: 11/12/2024
• Supplement Date Received by Manufacturer: 11/22/2024; 01/31/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 11/25/2024; 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2024
• 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: Required Intervention; Death
• Patient Age: 65 YR
• Patient Sex: Male