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

Model Number	VAMF3636C100TU
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2021
Type of Reportable Event	Death
Event or Problem Description
Valiant navion stent grafts (vnmc3737c90tu & vnmc3737c182tu) were implanted, during the reintervention of a prior thoracic aortic repair.The patient had 2 existing valiant captivia stent grafts implanted 5 years previoulsy.It was reported, core lab review of ct imaging taken approximately 2 years post.The navion implant, identified a new type ii endoleak.The max aortic diameter was noted, as 71.Mm.The imaging was na for aortic enlargement.No stent ring enlargement or stent ring migration was observed.The imaging was noted, as non evaluable for stent fractures.It was noted, on image review unable to fully identify navion devices, but largest strut measured and sre for both 37x37 devices. it was reported, the patient expired on an unknown date.The cause of the type ii endoleak and death is undetermined.
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: vamf3636c150tu, serial/lot #: (b)(6), ubd: 09-mar-2016, udi#: (b)(4).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 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: 19094726
• Report Number: 9612164-2024-01752
• Device Sequence Number: 7607342
• Product Code: MIH
• UDI-Device Identifier: 00643169347052
• UDI-Public: 00643169347052
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2015
• Device Model Number: VAMF3636C100TU
• Device Catalogue Number: VAMF3636C100TU
• 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: 04/04/2024
• Initial Report FDA Received Date: 04/12/2024
• Date Device Manufactured: 12/11/2013
• 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: Death
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 71 KG