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

Model Number	VAMF3030C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/01/2017
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 selected for the endovascular treatment of a thoracic ulcer.It was reported that the patient returned for a routine follow up.A ct revealed a small proximal type i endoleak.The physician elected to model the valiant stent graft with a balloon and the proximal type i endoleak was resolved.Per the physician, the exact cause of the proximal type i endoleak is cannot be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex.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: 6488094
• Report Number: 2953200-2017-00579
• Device Sequence Number: 16443610
• Product Code: MIH
• UDI-Device Identifier: 00643169346994
• UDI-Public: 00643169346994
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 03/21/2017

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: 02/19/2017
• Device Model Number: VAMF3030C150TU
• Device Catalogue Number: VAMF3030C150TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2017
• Supplement Date Received by Manufacturer: 03/21/2017
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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