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

Model Number	VAMC4444C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Rupture (2208)
Date of Event	12/20/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant captiva stent graft system was implanted in a patient for the endovascular treatment of a 72mm diameter thoracic aortic aneurysm.The patient also had a 47mm abdominal aortic pseudo-aneurysm proximal and a 24mm abdominal aortic pseudo-aneurysm proximal distal to previous open repair graft, which was not treated.Sizing sheets revealed an 11mm in length short concial proximal neck with moderate thrombus and calcification observed in the proximal pseudo-aneurysm.Severe calcification was also noted in both right and left iliac arteries.It was reported that the patient presented with a thoracic rupture and later died.The cause of the event is currently unknown.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
Additional information received; it was noted by the physician that the patient died from an apparent thoracic aorta rupture but the physician was not sure of the origin.The devices appeared on ct to have good seal and contrast continued to enter the taa sac.The possible conclusion was that the leak was coming from a collateral source of undetermined origin.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Film evaluation summary; the cause of the ruptured taa and patient death could not be determined from the films provided.A pre-implant 3d-ct film report revealed that the patient had a 72 mm max diameter fusiform taa that began 5 cm distal to the lsa, extending 17 cm distal to the lsa.The proximal neck diameter ranged from 37 ¿ 39 mm, with light scattered calcification observed.The distal seal zone diameter ranged from 40 ¿ 39 mm along a 3 cm length.Films during implant were not returned.Review of a chest cta 10 days post-implant revealed that 2 valiant stent grafts had been implanted in the patient, from just caudal to the lsa, extending across the arch and into the proximal portion of the descending thoracic, approximately 12 cm from the celiac artery origin.No stent graft issues were observed.There was ~10 cm of device overlap.The maximum diameter taa measured ~85 mm, no clear endoleak was seen, and the stent grafts were patent.Images from the rupture event were not available for return.Analysis of the returned films did not reveal any stent graft or anatomical characteristics that could explain the reported taa rupture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7233842
• Report Number: 2953200-2018-00173
• Device Sequence Number: 1317072
• Product Code: MIH
• UDI-Device Identifier: 00643169346819
• UDI-Public: 00643169346819
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 03/19/2018

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: 09/06/2019
• Device Model Number: VAMC4444C150TU
• Device Catalogue Number: VAMC4444C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Initial Date Received by Manufacturer: 01/11/2018
• Supplement Date Received by Manufacturer: 02/09/2018; 03/05/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 03/06/2018; 03/19/2018
• 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: 87 YR