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

Model Number	VAMF3636C150TU
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
Other relevant device(s) are: vamf3636c150tu sn (b)(4), expiration date: 2017-11-15, (b)(4).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 implanted in a patient for the endovascular treatment of a thoracic aortic dissection.It was reported that the patient returned for follow-up and the ct showed the patient developed a proximal type i endoleak.The patient has three stent grafts implanted from the original procedure.The valiant stent graft is distal and two stent grafts are proximal; however, it is unknown which device was the proximal most where the endoleak is coming from.The endoleak was on the inner curve of the arch.The physician implanted 12 endoanchors at the proximal end of the stent graft to try to resolve the endoleak.The original stent graft was at the level of the subclavian artery and the patient has a dialysis graft in the left arm so a proximal extension was not an option at this time.The procedure went well with the endoleak filling very late.Although, it was noted that the leak had appeared to resolve.The physician decided to stop and not perform any further intervention.The physician stated that the cause of the event was anatomy related (proximal neck degenerative disease since patient was treated for dissection on original procedure).No additional clinical sequelae were reported and the patient will be monitored by their physician.
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: 6592728
• Report Number: 2953200-2017-00864
• Device Sequence Number: 10954443
• Product Code: MIH
• UDI-Device Identifier: 00643169346963
• UDI-Public: 00643169346963
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 05/01/2017

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: 04/27/2017
• Device Model Number: VAMF3636C150TU
• Device Catalogue Number: VAMF3636C150TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 05/01/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 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: 64 YR