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

Model Number	VAMF4040C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/18/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The main component of the system.Other relevant devices are: (b)(4), s/n: (b)(4); use by date: (b)(6) 2019; upn # (b)(4).The main component of the system.Other relevant devices are: (b)(4), s/n: (b)(4); use by date: (b)(6) 2018; upn # (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant captivia stent graft system was implanted in a patient for the emergent endovascular treatment of a ruptured 36mm diameter thoracic aortic aneurysm.A valiant captivia 36x36x200 stent graft was placed proximally and a 40x40x200 was placed distally.However, it was reported that, during delivery of a third valiant captivia (40x40x150), the patient lost a-line pressure.The physician then removed the 40x40x150 without attempting deployment, and placed a reliant balloon in the thoracic aorta to occlude blood flow.Despite attempts to resuscitate, the patient died.Per the physician, the cause of the event was anatomical due to the rupture of the tortuous thoracic aorta.No other 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: 7085954
• Report Number: 2953200-2017-01930
• Device Sequence Number: 19147415
• Product Code: MIH
• UDI-Device Identifier: 00643169346949
• UDI-Public: 00643169346949
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2017

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: 08/17/2018
• Device Model Number: VAMF4040C150TU
• Device Catalogue Number: VAMF4040C150TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2017
• Initial Report FDA Received Date: 12/06/2017
• 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: 67 YR