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

Model Number	VAMF4040C200TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant stent graft system was implanted in a patient for the endovascular treatment of a 60mm diameter thoracic aortic aneurysm.It was reported that approximately three years later, the patient returned for follow up and a ct scan identified a type ia endoleak.The physician scheduled the patient for a proximal extension endograft to satisfy the neck growth and seal the endoleak.It was reported the patients¿ torturous anatomy in the descending thoracic aorta would not allow the extension to be advanced into the proper position for deployment.The effort was abandoned and femoral cut-downs repaired without patient injury.The issue has not been resolved.Per the physician, the cause of the event was due to the patients¿ torturous anatomy and disease pr ogression.Itwas reported disease progression contributed to a proximal neck dilation of the thoracic aorta beyond the dimensions of the graft.No additional clinical sequelae were reported and the patient will be monitored.

• 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: 7840767
• Report Number: 2953200-2018-01254
• Device Sequence Number: 1565232
• Product Code: MIH
• UDI-Device Identifier: 00643169346543
• UDI-Public: 00643169346543
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 09/03/2018

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: 12/18/2016
• Device Model Number: VAMF4040C200TU
• Device Catalogue Number: VAMF4040C200TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 09/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 70