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

Model Number	VNMC4640C200TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/24/2020
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
A valiant navion stent graft was implanted in the endovascular treatment of a 50mm thoracic aortic aneurysm.It was reported that a ct performed on an unknown date revealed that the patient had a gutter endoleak from the snorkel's placed at the original implant of the grafts.Intervention was performed three months after the index procedure where the physician extended the original snorkels and implanted a vnmc4646c95tu stent graft.As per the physician the cause of the event was the gutter leaks from the snorkels at the time of original implantation.No additional clinical sequelae were provided and the patient is fine.
Additional Manufacturer Narrative
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: 10032314
• Report Number: 9612164-2020-01805
• Device Sequence Number: 3116669
• Product Code: MIH
• UDI-Device Identifier: 00763000101275
• UDI-Public: 00763000101275
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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: 09/25/2021
• Device Model Number: VNMC4640C200TU
• Device Catalogue Number: VNMC4640C200TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 07/02/2020
• 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: 79 YR