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

Model Number	VAMC4238C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the reported distal type i endoleak could not be determined from the limited films provided.A video showing transverse ct slices confirmed that there was contrast outside the stent graft.Evidence of previous coiling was seen near the mid-level of the posterior taa.Beginning within the distal taa, contrast was seen outside the right/medial wall of the device, near the location where the stent grafts were angulated from vertical to a horizontal orientation.The exact source and cause of the endoleak could not be determined.Although there appeared to be adequate distal stent graft radial apposition, this may have been a distal type i endoleak possibly caused by disease progression; aortic dilatation.However, cannot rule out a type iii fabric endoleak which may have been due to stent abrasion caused by the stent graft angulation.
Event or Problem Description
A valiant stent graft system was implanted in a patient for the endovascular treatment of an 7cm diameter thoracic aortic aneurysm.It was reported that a recent ct demonstrated a distal type i endoleak and the aneurysm is currently 8.8cm in diameter.Per the physician, the cause of the distal type i endoleak is related to the patient¿s anatomy; disease progression.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - CW
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6570939
• Report Number: 2953200-2017-00791
• Device Sequence Number: 13705751
• Product Code: MIH
• UDI-Device Identifier: 00643169346703
• UDI-Public: 00643169346703
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/21/2017

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: 01/26/2017
• Device Model Number: VAMC4238C150TU
• Device Catalogue Number: VAMC4238C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: 04/21/2017
• Initial Report FDA Received Date: 05/16/2017
• 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
• Patient Age: 78 YR