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

Model Number VAMF3434C150TE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Paralysis (1997); Shock (2072); Vascular Dissection (3160)

Event Date 03/20/2024

Event Type  Death  

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.

Event Description

A valiant captivia stent graft (vamf3434c150te) was implanted during the endovascular treatment of a pau.The penetrating ulcer was situated 33mm from the left subclavian.It was reported during the index procedure, vamf3434c150te was successfully positioned and ct scan revealed no endoleaks. clinical f eedback indicated that the patient developed hemiplegia 2 days post-surgery.Following symptomatic treatment, a cta re-examination taken 7 days post the index procedure which confirmed the presence of reverse tear type a dissection. considering the patient¿s age, no further treatment was given.The patient suffered sudden shock one day later and despite rescue efforts expired.Per the physician the cause of the type a dissection was device related where the proximal bare stent caused the reverse tear type a dissection.

Manufacturer Narrative

Film evaluation summary: the reported dissection was confirmed on the films received, however the cause of this event could not be fully determined.The reported hemiplegia and patient death could not be assessed.It is possible that the proximal bare stent contributed to the type a dissection as it was observed from the films that the proximal bare stent was adjacent to the dissected area.It is also possible that unknown patient co-morbidities may have been a factor in the occurrence of the retrograde type a dissection.Analysis of the returned films did not reveal any obvious out of specification stent graft integrity issues.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 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: 19086973
• MDR Text Key: 339898084
• Report Number: 9612164-2024-01740
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 04/11/2024

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
• Device Operator: Health Professional
• Device Model Number: VAMF3434C150TE
• Device Catalogue Number: VAMF3434C150TE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/11/2024
• Date Device Manufactured: 09/30/2022
• 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): Death
• Patient Age: 74 YR
• Patient Sex: Male