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

Model Number	VAMF3232C200TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the possible proximal type i endoleak could not be conclusively determined from the 3 still cta images provided.Pre-implant anatomy information, films at implant, and additional post-implant films were not provided.The complete stent graft in-vivo configuration and complete anatomy information could not be assessed.
Event or Problem Description
A valiant stent graft system was implanted in the patient for the endovascular treatment of a 60 mm diameter thoracic aortic aneurysm.It was reported that approximately one month post index procedure a ct revealed that the valiant stent graft had a proximal type i endoleak.No treatment was performed and the event was not resolved.Per the physician the cause of the event was due to the patient anatomy of an angulated aortic neck.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.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: 6136916
• Report Number: 2953200-2016-02043
• Device Sequence Number: 19101265
• Product Code: MIH
• UDI-Device Identifier: 00643169347137
• UDI-Public: 00643169347137
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 11/09/2016

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: 04/25/2018
• Device Model Number: VAMF3232C200TU
• Device Catalogue Number: VAMF3232C200TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Initial Date Received by Manufacturer: 11/09/2016
• Supplement Date Received by Manufacturer: 11/09/2016
• Initial Report FDA Received Date: 11/30/2016
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 62