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

Model Number	VAMF4040C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemothorax (1896); Rupture (2208)
Date of Event	05/12/2020
Type of Reportable Event	Death
Event or Problem Description
A valiant navion stent graft (vnmf3428c173tu) was implanted during the re-intervention of a thoracic aortic repair.The patient had an existing valiant captivia thoracic stent graft (vamf4040c150tu) implanted.It was reported approximately 8 months post the navion implant procedure, follow up ct showed an apparent hemothorax consistent with aortic rupture.The imaging was na for aortic enlargement and the max aortic diameter measured at 114mm.A stent fracture was ne due to multiple overlapping devices.No stent ring enlargement or stent ring migration was observed.It was reported on an unknown date that the patient expired, the cause of death and circumstances surrounding the death are unknown.The cause of the hemothorax and aortic rupture are undetermined.
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.

• 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: 19372179
• Report Number: 9612164-2024-02472
• Device Sequence Number: 12646826
• Product Code: MIH
• UDI-Device Identifier: 00613994797667
• UDI-Public: 00613994797667
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 05/22/2024

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: 03/16/2014
• Device Model Number: VAMF4040C150TU
• Device Catalogue Number: VAMF4040C150TU
• 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: 04/30/2024
• Initial Report FDA Received Date: 05/22/2024
• Date Device Manufactured: 03/20/2012
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 64 KG