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

Model Number	VAMC3838C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant captivia stent graft system was implanted in a patient for the endovascular treatment of a thoracic aortic aneurysm.It was reported that ct imaging revealed that the distal end of the stent graft was floating in the aneurysm.Another valiant stent graft was implanted down to the level of the celiac artery.This reportedly resolved the event.The physician stated that the cause of the event was due to disease progression.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the cause of the reported lack of distal stent graft apposition could not be determined from the films provided.The anatomy at implant is unknown, and earlier post-implant films were not available for review and comparison.A 3d-ct film report from 4 years post-implant revealed that a single valiant stent graft had been implanted in the patient, and there was lack of distal stent graft apposition within the descending thoracic and a likely distal type i endoleak.No other obvious stent graft issues were observed.It is possible that the events were caused by disease progression; thoracic dilatation.Images after the intervention which resolved the event were not provided.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - CW
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6592989
• Report Number: 2953200-2017-00872
• Device Sequence Number: 225816
• Product Code: MIH
• UDI-Device Identifier: 00613994797315
• UDI-Public: 00613994797315
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2017

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: 07/03/2014
• Device Model Number: VAMC3838C150TU
• Device Catalogue Number: VAMC3838C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2017
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: Not provided; 06/07/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 06/09/2017; 10/03/2017
• 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: Required Intervention
• Patient Age: 73 YR