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

Model Number VAMF2424C100TE

Device Problem Leak/Splash (1354)

Patient Problem Chest Pain (1776)

Event Date 04/23/2024

Event Type  Injury  

Event Description

A valiant captivia stent graft ((b)(6)) was implanted during the emergent endovascular treatment of a 60mm thoracic aortic pseudoaneurysm in the descending aorta.The proximal diameter at the lsa was 21mm and 40mm in length.Thrombus/calcification was present at the proximal and distal implantation site.The patient had presented with chest pain one day before the index procedure.It was reported one day post the index procedure, the patient reported chest pain.Ct identified a type iiib endoleak suspected to be caused by a defect in the graft fabric.Intervention was performed where an additional valiant captivia stent graft ((b)(6)) was implanted within the existing valiant captivia stent graft, effectively resolving the type iiib endoleak.Per the physician the cause of the type iiib endoleak was due to a defect in the stent graft fabric.No additional clinical sequelae were provided, and the patient is fine.

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.

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
• Type of Device: 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: 19190146
• MDR Text Key: 341118136
• Report Number: 9612164-2024-01999
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VAMF2424C100TE
• Device Catalogue Number: VAMF2424C100TE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/01/2024
• Date Device Manufactured: 06/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 74 KG