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

Model Number	VNMC4337C200TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	07/16/2019
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 navion stent graft system was implanted in a patient for the endovascular treatment of a thoracic aortic dissection, from the lsa to the abdominal aorta.It was reported that during the implant procedure, a 37/90 valiant navion stent graft was implanted at the lcc and was then extended with a 43/37/200 valiant navion, with perfect overlap.It was reported that the physicians were then concerned that the 37/90 valiant navion was encroaching on the lcc, and they decided to place an 8/29 balloon-expandable bare stent for access.It was reported that on the day after the procedure, the patient presented emergently with an rtad.An open repair was performed as treatment.As per the physician, the cause of the event could not be determined.No additional clinical sequelae were reported and the patient is fine.

• 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: 8854090
• Report Number: 9612164-2019-03191
• Device Sequence Number: 2548151
• Product Code: MIH
• UDI-Device Identifier: 00763000101268
• UDI-Public: 00763000101268
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 08/02/2019

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: 01/02/2021
• Device Model Number: VNMC4337C200TU
• Device Catalogue Number: VNMC4337C200TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/02/2019
• 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: 60 YR