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	03/30/2017
Type of Reportable Event	Serious Injury
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 implanted in a patient for the endovascular treatment of a thoracic penetrating aortic ulcer.It was reported that a follow-up ct showed a proximal type i endoleak and the pau has grown to 6.2cm.The patient has a bovine arch and the original graft covered the subclavian.A carotid subclavian bypass was done at the original procedure.The subclavian was coiled.There was 18mm from the brachiocephalic to the proximal edge of the 36x36x200.The decision was made to place a valiant captivia to seal the type i endoleak.The graft was placed at the intended location and a reliant balloon was used.The type i endoleak was still filling at the end of the procedure.The physician ballooned multiple times with no success.It was noted that the patient was able to move their extremities at the end of the procedure.The patient was stable and otherwise symptom free.The physician stated that the cause of the event was due to disease progression vs graft not opposing wall due to bare stents on previous placed graft.No additional clinical sequelae were reported and the patient is will be monitored by the 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: 6575890
• Report Number: 2953200-2017-00800
• Device Sequence Number: 10919721
• Product Code: MIH
• UDI-Device Identifier: 00643169346567
• UDI-Public: 00643169346567
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2017

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: 05/06/2016
• Device Model Number: VAMF3636C200TU
• Device Catalogue Number: VAMF3636C200TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 04/24/2017
• Initial Report FDA Received Date: 05/18/2017
• 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: 70 YR