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

Model Number	VAMC3636C100TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	05/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant stent graft was implanted for the endovascular treatment of a thoracic aortic aneurysm.An endarterectomy was performed prior to implanting the stent graft due to calcified iliac arteries.During the procedure, after the delivery system was removed, the patient¿s blood pressure began to fall.An angiogram revealed the appearance of a small blush in the left external iliac artery, which the physician considered to be a perforation.The physician elected to implant two covered stents in the left iliac artery and the event was resolved.Per the physician, the cause of the vessel perforation was due to the patient anatomy of heavily calcified iliac arteries.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the reported left external iliac artery perforation occurring during implant could not be determined from the pre-implant films provided.Films during implant and post-implant were not available for review, and the stent graft in-vivo configuration could not be determined from the films provided.A 3-d ct film report noted that the patient had a 5.6cm max diameter taa within the descending thoracic aorta, a 3.8cm ulcer near the level of the lsa, as well as a 5cm diameter infrarenal aaa.The common and external iliac arteries were non-tortuous but extensively calcified bilaterally.The left common iliac artery diameter ranged from 12 ¿ 13 ¿ 10mm along the 45mm length.The left external iliac artery diameter was 8mm and the left access vessel diameter was 7.3mm and calcified.It is likely that the perforation was anatomy related; severely calcified iliac arteries.
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: 6592938
• Report Number: 2953200-2017-00868
• Device Sequence Number: 369470
• Product Code: MIH
• UDI-Device Identifier: 00643169347175
• UDI-Public: 00643169347175
• 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,Followup
• Report Date (Section B): 06/06/2017

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: 03/09/2019
• Device Model Number: VAMC3636C100TU
• Device Catalogue Number: VAMC3636C100TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: Not provided; 06/06/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 06/09/2017; 10/03/2017
• 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: Required Intervention
• Patient Age: 78 YR