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

Model Number	VNMF4040C103TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Death (1802)
Date of Event	06/08/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant stent graft was implanted in the patient for the endovascular treatment of a 60mm abdominal aortic aneurysm.It was reported that during the index procedure, the patient had a challenging location of the aneurysm as it was right on the aortic arch making it difficult to advance wires and the device into the planned proximal landing zone at the lcca.Two valiant navion stent grafts were placed but it was still considered that they weren't far enough proximally to obtain a good seal.The physician attempted to snare the distal tip of the wire from the groin to create a better route to navigate the anatomy.After several attempts with the snare they were unsuccessful.The physician then placed another valiant navion device proximal to the most proximal device to obtain the seal.There were several times where the interventional wire had to be repositioned over the arch in order to advance the devices.It was reported that a week post index procedure, the sales rep contacted the physician to enquire about the patient's condition.The physician explained that the patient suffered an embolic stroke and did not wake from the procedure and later died.As per the physician, the cause of the stroke event was unclear but likely was procedural related but not device related.No additional clinical sequelae were reported.

• 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: 10217747
• Report Number: 9612164-2020-02377
• Device Sequence Number: 14094564
• Product Code: MIH
• UDI-Device Identifier: 00763000100711
• UDI-Public: 00763000100711
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 07/01/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/22/2021
• Device Model Number: VNMF4040C103TU
• Device Catalogue Number: VNMF4040C103TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 07/01/2020
• 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: Death; Life Threatening