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	01/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant stent graft system was implanted in a patient for the endovascular treatment of a 4.7 cm in diameter thoracic aorta aneurysm.It was reported that the patient returned for follow up.The ct revealed that here was a distal type i endoleak.The physician elected to treat the patient by implanting two thoracic aortic stent graft extensions and the endoleak was resolved.Per the physician, the cause of the event was due to loss of apposition to the aortic wall that may have been due to aortic dilatation at that location.No additional clinical sequelae were reported and the patient is fine.
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: 6298934
• Report Number: 2953200-2017-00147
• Device Sequence Number: 13566672
• Product Code: MIH
• UDI-Device Identifier: 00643169346963
• UDI-Public: 00643169346963
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2017

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: 11/15/2017
• Device Model Number: VAMF3636C150TU
• Device Catalogue Number: VAMF3636C150TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2017
• Supplement Date Received by Manufacturer: 01/26/2017
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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: 72 YR