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

Model Number	VAMF3430C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Multiple Organ Dysfunction Syndrome (3261)
Date of Event	04/13/2017
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 type b dissection extended from the left subclavian artery distally to the iliac artery.It was reported that the patient presented with a type b dissection that was creating malperfusion to the renal arteries, visceral arteries, and lower extremities.Upon arrival to the emergency room the patient coded.The final angiogram revealed that the valiant stent graft was successfully implanted.When the patient was being moved from the operating table to bed the patient coded again and expired.The physician stated that the cause of the death was related to the patient¿s malperfusion of all the renal arteries and visceral arteries.It was noted that, post implant, the anatomy looked great and there was blood flow to the renal and visceral arteries.The physician stated that the stent graft was not the cause, that the patient had symptoms for a week, and that he believed the malperfusion over an extended time was probably the cause of the event.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: 6553108
• Report Number: 2953200-2017-00754
• Device Sequence Number: 13605376
• Product Code: MIH
• UDI-Device Identifier: 00643169400146
• UDI-Public: 00643169400146
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 04/13/2017

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: 01/25/2018
• Device Model Number: VAMF3430C150TU
• Device Catalogue Number: VAMF3430C150TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2017
• Supplement Date Received by Manufacturer: 04/13/2017
• Initial Report FDA Received Date: 05/08/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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: 45 YR