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

Model Number	VAMF4242C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Vascular Dissection (3160)
Date of Event	03/23/2017
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 33.0 cm in length thoracic aortic dissection.It was reported that the patient presented emergently with an enlarging thoracic aneurysm following thoracic endovascular repair (tevar) for a type b aortic dissection (tbad).It was also reported that there was a type ii endoleak and an expanding tbad false lumen with multiple new native fenestrations in the intima.There were multiple native fenestrations in the descending thoracic aorta intima and abdominal aorta intima.The physician stated that the cause appeared to be the left subclavian artery (lsa) perfusing the false lumen after the index procedure, where an lca to lsa bypass was performed; as well as a large distal fenestration which was providing distal flow in the false lumen.Both were suspected to be contributing to the continued growth.The lsa was embolized and a distal extension was placed that extended coverage from the mid descending thoracic aneurysm to the superior mesenteric artery.This reportedly resolved the event.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the cause of the enlarging taa could not be determined from the limited films provided.The anatomy at implant is unknown, and images during implant were not provided.Review of ct¿s from 7 months post-implant revealed that the patient had been implanted with a valiant captivia stent graft system.The chest-ct¿s provided were cut-off distally across the aortic arch; therefore, only images of the ~10mm proximal portion of the stent graft(s) were seen in the returned images.Beginning just distal to the lsa contrast was seen outside the stent graft.The exact source of the contrast could not be determined from the films.It is possible that the reported type ii endoleak and the false lumen perfusion from multiple fenestrations may have all contributed to the taa expansion.Films during the intervention which reportedly resolved the event were also not available.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.
Additional Manufacturer Narrative
Corrected information: sex., date of birth, no eval explain code.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: 6495575
• Report Number: 2953200-2017-00602
• Device Sequence Number: 1331423
• Product Code: MIH
• UDI-Device Identifier: 00643169346932
• UDI-Public: 00643169346932
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2018
• Device Model Number: VAMF4242C150TU
• Device Catalogue Number: VAMF4242C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: Not provided; 05/08/2017
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 05/31/2017; 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: 58 YR
• Patient Weight: 99