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

Model Number	VNMC4040C55TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	12/12/2018
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 navion stent graft was implanted in a patient for the endovascular treatment of a thoracic aortic ulcer.It was reported that the patient had a good 1 week post operative scan, however presented with an ascending aortic dissection at the 1 month scan.The dissection was visible proximal to and behind the implanted device.The patient has not received treatment, as the physician opted for observation.As per the physician, the cause of the event may be device oversizing, but feels the issue relates to the imh and weak tissue in the patient's anatomy.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Additional information: it was reported that the ulcer was located proximal to the lsa and the proximal end of the stent graft was implanted in zone 0 of the ascending aorta.It was reported that 10-20% stent graft oversizing was used.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: 8206317
• Report Number: 9612164-2018-03790
• Device Sequence Number: 2069306
• Product Code: MIH
• UDI-Device Identifier: 00763000101084
• UDI-Public: 00763000101084
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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: 10/07/2020
• Device Model Number: VNMC4040C55TU
• Device Catalogue Number: VNMC4040C55TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 12/31/2018
• Supplement Report FDA Received Date: 01/31/2019
• 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: Hospitalization
• Patient Age: 88 YR