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

Model Number	VAMF4242C150TU
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	05/08/2018
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 an unknown size thoracic aortic aneurysm.It was reported that during the index procedure, the physician attempted to insert the device but once at the aortic arch it would not pass over the arch, even after several attempts.During this process the iliac vein tore and the device was removed to get control of the iliac vein.He then attempted to pass the device again but it would still not pass.Another longer stent graft was then used which was successfully deployed and implanted to complete the procedure.As per the physician, the cause of the event was anatomy related.No additional clinical sequelae were reported and the patient is fine.

• 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: 7552087
• Report Number: 2953200-2018-00784
• Device Sequence Number: 16651478
• Product Code: MIH
• UDI-Device Identifier: 00643169346932
• UDI-Public: 00643169346932
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2018
• Device Model Number: VAMF4242C150TU
• Device Catalogue Number: VAMF4242C150TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 05/30/2018
• 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