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

Model Number	VAMF4040C200TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 selected for the endovascular treatment of a 6.6 cm in diameter thoracic aortic aneurysm.It was reported that a recent ct revealed a proximal type i endoleak.Per the physician, the cause of the proximal type i endoleak related to the patient¿s anatomy, diseased thoracic aorta multiple thoracic aortic aneurysms.No additional clinical sequelae were reported and the patient will be monitored by the physician.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the proximal type i endoleak could not be determined from the films provided.The anatomy at implant is unknown, and earlier post-implant films were not available for review and comparison.Ct¿s from 4 years post-implant revealed that a single valiant captivia stent graft had been implanted; the proximal extent of the device was positioned ~7cm caudal to the lsa.The device extended across the arch and into the proximal section of the descending thoracic.The proximal od measured ~42mm, the thoracic aortic diameter measured ~50mm at that same level, and there appeared to be a proximal type i endoleak.The taa was aneurysmal nearly the complete length of the thoracic stent graft, and measured a maximum diameter of ~7cm near the distal end of the device.The thoracic was also aneurysmal and acutely angulated distal to the device.It is possible that the endo leak was anatomy related; disease progression (neck dilatation) and morphology changes.
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: 6583375
• Report Number: 2953200-2017-00827
• Device Sequence Number: 1134358
• Product Code: MIH
• UDI-Device Identifier: 00613994797988
• UDI-Public: 00613994797988
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2015
• Device Model Number: VAMF4040C200TU
• Device Catalogue Number: VAMF4040C200TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Initial Date Received by Manufacturer: 04/26/2017
• Supplement Date Received by Manufacturer: Not provided; 05/25/2017
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 06/06/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR