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

Model Number	VAMF4444C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2016
Type of Reportable Event	Malfunction
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 was implanted in the patient for the endovascular treatment of a proximal type i endoleak.It was reported that the patient had a re-intervention.After the left carotid artery to left subclavian artery pass was performed a 44/44/150 valiant captivia stent graft was implanted.Post angiogram demonstrated that the type ia endoleak was not resolved.A reliant balloon was gently inflated and the leak showed slight improvement.The patient tolerated the procedure without any incidents.The physician will continue to monitor the patient.The physician stated that the type ia endoleak was most likely caused by disease progression and uncontrolled hypertension.
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: 6170834
• Report Number: 2953200-2016-02108
• Device Sequence Number: 828778
• Product Code: MIH
• UDI-Device Identifier: 00643169346925
• UDI-Public: 00643169346925
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/07/2016

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: 11/01/2018
• Device Model Number: VAMF4444C150TU
• Device Catalogue Number: VAMF4444C150TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: 12/07/2016
• Initial Report FDA Received Date: 12/13/2016
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR