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

Model Number	VAMC4242C100TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802); Pain (1994); Rupture (2208)
Date of Event	01/25/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products: vamc4242c150tu, sn (b)(4), expiration date: 2017-11-03, (b)(4).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 captivia stent graft system was implanted in a patient for the endovascular treatment of a thoracic aortic aneurysm.It was reported that the patient presented emergently with pain and an enlarged aneurysm with a rupture.It was noted that there was no visible endoleak.The patient expired as a result of the rupture.The physician stated that the cause of the event could not be determined.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the aneurysm expansion leading to the rupture and patient death could not be determined from the films provided.The anatomy at implant was not provided, and earlier post-implant films were not available for review.Earlier images returned were non-contrast; therefore, no assessment of any endoleak or stent graft/vessel patency could be performed.Recent ct¿s showed no clear endoleak.However, there appeared to be a small (20 ¿ 30mm) amount of overlap between 2 devices within the 90° acute angulated portion of the descending thoracic.The amount of overlap at implant is unknown.Although no endoleak was observed, it is possible that the taa was being pressurized from this stent graft junction due to a marginal junctional overlap within the angulated section of the thoracic.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - CW
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6337341
• Report Number: 2953200-2017-00214
• Device Sequence Number: 1610368
• Product Code: MIH
• UDI-Device Identifier: 00643169347144
• UDI-Public: 00643169347144
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2017

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: 08/17/2017
• Device Model Number: VAMC4242C100TU
• Device Catalogue Number: VAMC4242C100TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: Not provided; 03/08/2017
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 03/15/2017; 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: 74 YR