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

Model Number	VAMF3636C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Vascular Dissection (3160)
Date of Event	09/24/2017
Type of Reportable Event	Death
Event or Problem Description
A valiant stent graft system was implanted in the patient for the treatment of a penetrating aortic ulcer near the left subclavian artery.Prior to the index procedure the physician performed a great vessel debranching by placing a graft off the ascending arch and bypassing the innominate artery and left carotid artery.This was achieved via a sternotomy and implantation of a non-medtronic graft.It was reported that the patient had a cardiac arrest and was resuscitated.An emergency ct performed showed a retrograde type a dissection that appears to have originated at a piece of plaque on the lesser curve.The patient was taken to or immediately to perform an ascending repair, however the patient¿s chest was full of blood and arrested again and expired.Per the physician, the cause of the event cannot be determined as no autopsy was performed therefore unable to determine if the dissection happened due to the graft, surgical procedure before implant or anything other condition.No additional clinical sequelae were reported.

• 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: 6960664
• Report Number: 2953200-2017-01594
• Device Sequence Number: 719118
• Product Code: MIH
• UDI-Device Identifier: 00643169346963
• UDI-Public: 00643169346963
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2017

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: 08/17/2019
• Device Model Number: VAMF3636C150TU
• Device Catalogue Number: VAMF3636C150TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2017
• Initial Report FDA Received Date: 10/19/2017
• 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; Required Intervention
• Patient Age: 66 YR