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

Model Number	VNMC4343C55TU
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2019
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 navion stent graft system was implanted in a patient for the endovascular treatment of a thoracic aortic ulcer.It was reported that after deployment of the stent graft in the ascending aorta, when the physician was attempting to remove the delivery system, the stent graft was pulled distally.After several attempts, the physician was able to remove the delivery system without pulling the stent graft any further distally.The stent graft position was further distal than initially intended, but the physician was satisfied with the final location.Three stent grafts in total were deployed in the ascending aorta during the procedure.As per the physician, the cause of the event could not be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information received: it was reported during the index procedure that difficulty was encountered when advancing the delivery catheter beyond the arch into the ascending aorta due to significant tortuosity of the aortic arch.It was noted the physician had to use a force greater than anticipated to remove the device due to tortuosity.No difficulty was encountered deploying the stent graft or retracting the tip into the outer sheath but the delivery system appeared to become caught on the stent graft making it difficult to remove.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT NAVION
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8411371
• Report Number: 2953200-2019-00357
• Device Sequence Number: 19375704
• Product Code: MIH
• UDI-Device Identifier: 00763000101121
• UDI-Public: 00763000101121
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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: 10/07/2020
• Device Model Number: VNMC4343C55TU
• Device Catalogue Number: VNMC4343C55TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR