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

Model Number	VAMF2222C100TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	02/06/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant captivia stent graft was implanted in the patient for the emergent treatment of an endovascular transection caused by blunt trauma.However, it was reported that the patient died approximately 96 hours post implant of the stent graft.There was no evidence of stent graft failure on the follow up scan.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
Films review summary: from the films provided the cause of death could not be determined.Pre-implant films confirmed the transected thoracic aorta located in the arch ~3cm caudal to the lsa.The thoracic flow lumen diameter just past the lsa and near the transection was ~19mm, and distal to the transection along the descending thoracic ranged from 17 ¿ 15mm.No appreciable calcification, thrombus, or tortuosity was observed.Ct¿s from 5 days post-implant revealed that a single valiant stent graft had been implanted from just caudal to the lsa, extending across the arch and into the descending thoracic.The thoracic transection appeared to have been excluded, the device was patent, and no stent graft issues were observed.The cause of death was not reported, and analysis of the returned films device did not reveal any stent graft characteristics that could explain the cause of death.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7023922
• Report Number: 2953200-2017-01753
• Device Sequence Number: 1398982
• Product Code: MIH
• UDI-Device Identifier: 00643169347120
• UDI-Public: 00643169347120
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018

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: 11/08/2017
• Device Model Number: VAMF2222C100TU
• Device Catalogue Number: VAMF2222C100TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 11/13/2017
• Supplement Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 56 YR