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

Model Number	VAMF3636C200TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exact date of event is unknown.
Event or Problem Description
A valiant captivia stent graft system was implanted in a patient for the endovascular treatment of a 6cm diameter thoracic aortic aneurysm.It was reported there appeared to be a type ib endoleak on ct scan.The physician brought the patient back to or and angiography did show an endoleak but it¿s source was not determined.The physician placed a valiant main 2cm distal to original valiant device this resolved the endoleak.The physician is still unsure if it was a type ib or type iii.The physician stated that the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is fine.
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: 6635784
• Report Number: 2953200-2017-00964
• Device Sequence Number: 13096
• Product Code: MIH
• UDI-Device Identifier: 00643169346567
• UDI-Public: 00643169346567
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/30/2018
• Device Model Number: VAMF3636C200TU
• Device Catalogue Number: VAMF3636C200TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 10/04/2017
• 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: 80 YR