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

Model Number	VAMC4242C200TU
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	11/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant stent graft system was implanted in a patient for endovascular treatment of a thoracic aortic aneurysm.It was reported that during the removal of the second valiant stent graft delivery system there was left iliac limb perforation.The physician implanted another manufacturer¿s covered stent in the left common iliac artery extending into the external iliac artery.The perforation was excluded and resolved.Per the physician, the cause of the event is related to the patient¿s anatomy;the patient¿s artery had contracted/spasmed when the delivery system was being removed from the patient.No additional clinical sequelae were reported and the patient is fine.

• 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: 7069041
• Report Number: 2953200-2017-01891
• Device Sequence Number: 16580617
• Product Code: MIH
• UDI-Device Identifier: 00643169346734
• UDI-Public: 00643169346734
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2017

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: 01/07/2018
• Device Model Number: VAMC4242C200TU
• Device Catalogue Number: VAMC4242C200TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 11/29/2017
• 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: 69 YR