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

Model Number VAMC3232C150TE

Device Problems Leak/Splash (1354); Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Date 03/06/2024

Event Type  Injury  

Event Description

A valiant captivia stent graft was implanted in the endovascular treatment of a thoracic dissection and aneurysm.1 year and 5 months later a valiant navion ((b)(6)) stent graft was implanted to treat a type ia endoleak.The taa diameter was 68mm.During the intervention procedure, a carotid subclavian bypass on the left with 6 mm ring-reinforced ptfe prosthesis, followed by the implant of the valiant navion and plug closure of the subclavian artery from the brachial left was performed and a non mdt stent was placed at the outlet of the common carotid artery on the left, vascular suture of the brachial artery on the left.Per the physician the cause of the type ia endoleak was probably due to the very narrow landing zone distal to the left subclavian artery.Four years post the implant of the a valiant navion stent graft ,a follow up ct showed contrast medium exit from the navion graft m aterial, in the sense of a material defect (graft tear).Per the physician the cause of the suspected type iiib endoleak is possibly device related.It is suspected that the type iiib endoleak in the valiant navion stent graft may have been caused by the stent struts from the previously implanted valiant captivia.No additional clinical sequalae were provided and the patient will be monitored.

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

B5; additional information received; corelab review of ct imaging from approximately 4 years since the navion implantation identified a type iiib endoleak and stent ring enlargement of +2.9mm on device vnmc3737c182te (v29789816).No fracture or stent ring migration were noted.Aortic enlargement of +5.4mm was observed when compared to previous imaging from 2 days after implantation.The maximum aortic diameter was noted to measure 78.9mm.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 - CW
• 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: 18977161
• MDR Text Key: 338553203
• Report Number: 9612164-2024-01453
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 04/12/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2020
• Device Model Number: VAMC3232C150TE
• Device Catalogue Number: VAMC3232C150TE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/12/2024
• Date Device Manufactured: 02/20/2018
• 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: 62 YR
• Patient Sex: Female