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

Model Number	VAMF3636C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/01/2025
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 was implanted during the endovascular treatment of a taa.It was noted that the patient had a hemothorax and a mycotic aneurysm.The implantation proceeded without issue, and the prosthesis was ballooned along its entire length.Following the procedure, the patient was initially stable with no leakage observed.The patient subsequently reported pain, prompting a repeat computed tomography scan performed three days later, which revealed a type iii endoleak.Another prosthesis was placed which resolved the endoleak.Per the physician the cause of the endoleak could not be determined.
Additional Manufacturer Narrative
Film analysis the reported endoleak was confirmed in the imaging provided; however, the exact cause and subtype of endoleak could not be definitively determined.Lack of pre-implant ct; s did not allow for assessment of the pre-implant anatomy.Endoleak interrogation via selective angiograms (i.E., injecting contrast from different levels within the stent graft) to help determine the source and rule out other potential endoleak sources was not available for review.Proximal (type ia) and distal (type ib) endoleaks are unlikely, as adequate proximal and distal seal zones were observed.A type iiia endoleak caused by stent graft separation is also unlikely, given that only one stent graft was implanted in the descending thoracic aorta within the images where the endoleak was identified.While type iiib fabric endoleak is less likely to occur so soon after the index procedure, it cannot be ruled out; however, analysis of the returned films did not reveal any obvious anatomical factors (e.G., calcification) that could have contributed an acute type iii endoleak.Retrograde flow from patent intercostal arteries may have been present.Additionally, no obvious out of specification stent graft integrity issues were identified.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: 22335607
• Report Number: 9612164-2025-03171
• Device Sequence Number: 9126112
• Product Code: MIH
• UDI-Device Identifier: 00643169346963
• UDI-Public: (01)00643169346963(17)250913(21)V31243671
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: 09/13/2025
• Device Model Number: VAMF3636C150TU
• Device Catalogue Number: VAMF3636C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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 Sex: Unknown