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

Model Number	VAMF2626C150TU
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Stroke/CVA (1770); Death (1802); Occlusion (1984)
Date of Event	03/06/2017
Type of Reportable Event	Death
Event or Problem Description
A valiant stent graft system was implanted in a patient for the emergent endovascular treatment of a ruptured thoracic ulcer bleeding into the airway.During the initial emergent implantation, the valiant stent graft was unbeknownst and inadvertently implanted covering both subclavian arteries.There was an unknown aberrant right subclavian distal to the left subclavian artery.At the time of implant the patient was unstable and could not tolerate a carotid to subclavian bypass, but would be scheduled for a later date.It was reported that the unbeknownst covering of both subclavian arteries resulted in a cva/stroke and the patient expired eight days later.Per the physician, the causes of the events were related to the patient¿s anatomy.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
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: 6488076
• Report Number: 2953200-2017-00578
• Device Sequence Number: 11062592
• Product Code: MIH
• UDI-Device Identifier: 00643169347014
• UDI-Public: 00643169347014
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/21/2017

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: 04/28/2018
• Device Model Number: VAMF2626C150TU
• Device Catalogue Number: VAMF2626C150TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2017
• Supplement Date Received by Manufacturer: 03/21/2017
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 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: Death
• Patient Age: 57 YR