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

Model Number	VAMF3232C150TU
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	03/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the reported migration leading proximal type i endoleak and aneurysm enlargement cannot be conclusively determined from the films provided.Pre-implant anatomy information, films at implant, and earlier post-implant films were not returned for review and comparison.The stent graft location at implant was unknown.It was unclear if the stent graft migrated since implant.The films provided showed that there was a possible proximal type i endoleak due to lack of proximal stent graft seal to the inner curvature of the aortic arch.The stent graft was acutely angulated near the second stent ring.It is likely that the aorta surrounding the proximal stent graft may have dilated due to disease progression.Thoracic vessel dilatation combined with acute angulation in the stent graft may have contributed to the events.
Event or Problem Description
A valiant captivia stent graft system was implanted in a patient for the endovascular treatment of a 5.8 cm thoracic aortic aneurysm.It was reported that, a ct taken, revealed that the valiant device appeared to be 26mm back from the innominate artery causing a type ia endoleak and aneurysm growth.No clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received.The physician elected to implant an additional valiant device and extended coverage up to the origin of the left common carotid artery.The event was resolved after the intervention was performed.Per the physician, the cause of the event was unknown.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.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: 6451001
• Report Number: 2953200-2017-00504
• Device Sequence Number: 16338730
• Product Code: MIH
• UDI-Device Identifier: 00613994797704
• UDI-Public: 00613994797704
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2017

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: 10/18/2014
• Device Model Number: VAMF3232C150TU
• Device Catalogue Number: VAMF3232C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: Not provided; 04/10/2017
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 05/04/2017; 10/02/2017
• 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: 60 YR