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

Model Number	VAMF3838C200TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Rupture (2208)
Date of Event	02/03/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The main component of the system.Other relevant device(s) are: vamc4444c200tu, sn (b)(4), expiration date: 2018-06-20, (b)(4), vamc4444c200tu, sn (b)(4), expiration date: 2017-03-22, (b)(4).Evaluation summary: the cause of the possible aneurysm rupture occurring after implant, leading to the patient¿s death, could not be determined from the pre-implant films provided.Films during and post-implant were not available for review, and no issues were reported during implant prior to the possible rupture.Pre-implant films revealed that the patient had a severely tortuous thoracic; the arch was acutely angulated ~150°, and another area of acute angulation of ~100° was seen along the descending thoracic.The patient¿s distal seal length was also short; <(><<)>20 mm.It is possible that the patient¿s severely tortuous anatomy and short distal seal may have led to the possible aneurysm rupture.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 endovascular treatment of a 65 mm max diameter thoracic aortic aneurysm.The proximal aortic neck diameter ranged from 36-33 mm along a 39 mm length.The distal aorta diameter measured ~ 39 mm.The patient has a steep and angulated aortic arch.It was reported that after the implant procedure, the patient expired due to a possible aneurysm rupture.Per the physician, the cause of the aneurysm rupture leading to patient death was unknown.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: 6365357
• Report Number: 2953200-2017-00295
• Device Sequence Number: 13461448
• Product Code: MIH
• UDI-Device Identifier: 00643169346550
• UDI-Public: 00643169346550
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/03/2017

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: 01/04/2018
• Device Model Number: VAMF3838C200TU
• Device Catalogue Number: VAMF3838C200TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Initial Date Received by Manufacturer: 02/03/2017
• Supplement Date Received by Manufacturer: 02/03/2017
• Initial Report FDA Received Date: 02/28/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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: 81 YR