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

Model Number	VAMF3838C100TU
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	04/11/2018
Type of Reportable Event	Serious Injury
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 planned for implantation in a patient for the endovascular treatment of a 50 mm diameter a penetrating descending aortic aneurysm.An endurant stent graft system was also used for the treatment of an abdominal aortic aneurysm.The patients access vessels ranged in diameter between 6.2-7.2 mm.It was reported that during the index procedure the valiant device was attempted to be delivered but was unable to pass due to the narrow and calcified access vessels.The valiant was tried bare-back with no success.18 and 20f dilators were then used to attempt delivery of device again via an aortic bifurcate but this was unsuccessful.Angiography then showed perforation of the external iliac and distal common femoral arteries.This perforation required surgical bypass repair and additionally the aneurysm was successfully treated.The pau remains untreated.As per the physician, the cause of the event was anatomy related due to the narrow and calcified access vessels.No additional clinical sequelae were reported and the patient will be monitored.

• Brand Name: VALIANT CAPTIVIA
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7494084
• Report Number: 2953200-2018-00663
• Device Sequence Number: 194158
• Product Code: MIH
• UDI-Device Identifier: 00643169347045
• UDI-Public: 00643169347045
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2018

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: 07/05/2019
• Device Model Number: VAMF3838C100TU
• Device Catalogue Number: VAMF3838C100TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/08/2018
• 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