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

Catalog Number	VAMF3838C100TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/19/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A valiant captivia stent graft (vamf3838c100tu, sn (b)(6))was implanted during an endovascular procedure.It was reported that approximately 2 years and 1 month post-index procedure, a type ia endoleak was identified.Approximately one month later, , an intervention was performed to treat the endoleak.It was reported that during the procedure, which involved a valiant captivia stent graft of the same model (sn (b)(6)), resistance was felt during insertion of the delivery system into the patient.The physician reported difficulty advancing the delivery system into the vessel and did not feel comfortable applying additional force.Upon inspection, a gap was observed in the delivery system between the nose cone and the graft cover.No damage to the device or the device's packaging was noted prior to use.A new valiant captivia stent graft of the same model (sn (b)(6)) was used as a replacement and was successfully implanted, resolving the type ia endoleak.Per the physician, the cause of the positioning difficulty/gap was attributed to a defective device and there was no vessel calcification, thrombus or tortuosity that may have contributed to the this event.No cause for the endoleak was provided.No additional sequelae were reported, and the patient is doing well.
Additional Manufacturer Narrative
Additional information received: the cause of the type ia endoleak, as reported by the physician, was due to disease progression.Correction to b5: the previously reported sentence: "it was reported that during the procedure, which involved a valiant captivia stent graft of the same model (sn (b)(6)), resistance was felt during insertion of the delivery system into the patient" should read " it was reported that during the procedure, which involved a valiant captivia stent graft of the same model (sn v31338943), resistance was felt during insertion of the delivery system into the patient" instead 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: 22575526
• Report Number: 9612164-2025-03592
• Device Sequence Number: 21196627
• Product Code: MIH
• UDI-Device Identifier: 00643169347045
• UDI-Public: (01)00643169347045(17)240905
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 07/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2024
• Device Catalogue Number: VAMF3838C100TU
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female