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

Model Number	VAMC3232C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Perforation of Vessels (2135)
Date of Event	01/02/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Off-label, unapproved or contraindicated use (type a dissection) 18-failure to follow instructions (deployed antegrade through direct exposure of descending thoracic aorta).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
A valiant stent graft system was implanted in the patient for the emergent endovascular treatment of a thoracic aortic type a dissection.The type a dissection caused near occlusion of the celiac artery, superior mesenteric artery, right renal artery, and left common iliac artery.The patient entered surgery with end organ compromise.The devices were deployed antegrade through direct exposure of the descending thoracic aorta.It was reported that, during the index procedure, the physician implanted the first valiant stent graft and then elected to implant a second valiant stent graft to gain additional proximal coverage.The distal end of the second valiant stent graft was then sewn to the proximal edge of the thoracic aorta.However, after the aortic clamp to the body was removed, the physician observed that the descending thoracic aorta was exposed, that the second valiant stent graft was protruding from the aorta, and that there was insufficient blood flow.The physician elected to explant the valiant stent grafts, implanted a dacron graft, and completed the procedure.However, the patient did not recover and expired on the operating table.Per the physician, the cause of the event was unknown but the end organ compromise and deep hypothermic circulatory arrest time likely impacted the patient¿s ability to recover.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 - CW
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6251915
• Report Number: 2953200-2017-00055
• Device Sequence Number: 874071
• Product Code: MIH
• UDI-Device Identifier: 00643169346581
• UDI-Public: 00643169346581
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2017

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: 10/03/2018
• Device Model Number: VAMC3232C150TU
• Device Catalogue Number: VAMC3232C150TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2017
• Supplement Date Received by Manufacturer: 01/02/2017
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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: 53 YR