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

Model Number	VNMF4040C62TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/13/2020
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
An endurant iis stent graft system and valiant navion stent graft were implanted in a patient for the endovascular treatment of a type iii endoleak in a non-mdt stent graft.The endurant iis stent graft system was used to re-line the non-mdt stent graft and the valiant navion was placed as a cuff out of the endurant iis to resolve the endoleak.It was reported that the patients six-month ct scan showed a type ia endoleak.Approximately three weeks later an endurant ii stent graft cuff ettf3636c70e was placed at the level of the sma and extended to the main stent graft body.There was no endoleak observed post-procedure.As per the physician, the cause of the event was due to disease progression and a failed non-mdt graft.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 ; IE
• MDR Report Key: 10032046
• Report Number: 9612164-2020-01802
• Device Sequence Number: 3116666
• Product Code: MIH
• UDI-Device Identifier: 00763000100704
• UDI-Public: 00763000100704
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2020

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: 03/03/2021
• Device Model Number: VNMF4040C62TU
• Device Catalogue Number: VNMF4040C62TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 05/07/2020
• 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