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

Model Number	VAMF3838C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant stent graft system was implanted in a patient for the endovascular treatment of a 70mm thoracic aortic aneurysm.It was re ported that a type ia endoleak was observed following a ct scan carried out 5 months later.The physician has reported that that cause of the event cannot be determined.No additional clinical sequelae were reported, and the patient is being monitored.
Additional Manufacturer Narrative
Film evaluation summary; the exact cause of the proximal type i endoleak leading to the taa expansion could not be determined from the films provided.The anatomy at implant is unknown and earlier post-implant films were not available for comparison.Review of a ct film report 5 months post-implant revealed that the patient had been implanted with 2 valiant stent grafts, the taa maximum diameter measured 85mm, and there was a likely proximal type i endoleak.The proximal device was positioned 4mm caudal to the left carotid artery, and 15mm from the innominate.Near the proximal graft margin (fabric) the thoracic diameter was 34mm, and 20mm caudal near the level of the lsa a likely proximal type i endoleak was visible.The stent graft od near the lsa was 35mm and the thoracic diameter at that same level measured 39mm, and 30mm caudal to the lsa the taa diameter measured 85mm.It is possible that disease progression (thoracic aorta dilatation) may have contributed to the proximal type i endoleak.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7474967
• Report Number: 2953200-2018-00632
• Device Sequence Number: 1963793
• Product Code: MIH
• UDI-Device Identifier: 00643169346956
• UDI-Public: 00643169346956
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2019
• Device Model Number: VAMF3838C150TU
• Device Catalogue Number: VAMF3838C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR