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

Model Number	VNMF4040C183TU
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Death (1802); Ruptured Aneurysm (4436)
Date of Event	10/09/2020
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 navion stent graft was implanted in the emergent endovascular treatment of a 80mm ruptured thoracic aortic aneurysm.The patient was hypotensive and was taken directly to or.The patient had extremely calcified access bilaterally, which included a total occlusion of the left proximal femoral and a focal stenosis of the right external iliac.The aneurysm began approximately 2.5cm from the left subclavian with the distal landing zone beginning approximately 175mm from the left subclavian.The proximal and distal landing zones measured 35mm.During the index procedure, open cutdown was performed in the right femoral artery to aid delivery of the valiant navion's delivery system.Prior to its insertion, the right external iliac artery was predilated with an 8mmx 40mm non mdt balloon and a 16fr sheath.The valiant navion device was then introduced over a stiff wire.After multiple attempts the device would not track through the native femoral artery.A non mdt balloon expandable stent was then implanted in the area of the right femoral stenosis.The device then tracked through the non- mdt stent and was advanced to the intended target.There was high resistance on the delivery system during deployment which made the delivery system and device shift forward.After accounting for the proximal migration and repositioning to the intended location, the remainder of the device was deployed.After relaxing pressure on the delivery system the proximal free flo stent was attempted to be released via the tip capture mechanism.The appropriate steps we followed however the leading edge of the device failed to deploy.Troubleshooting steps were completed <(>&<)> the stiff wire was pulled back to relax the delivery system, which released strain on the tip of the catheter.This resolved the issue and the device then fully deployed at the intended zone.The patient survived the procedure but expired the following day.The cause of death was the ruptured 80mm aneurysm and the patient being continuously hypotensive throughout the procedure.As per the physician the cause of the event can not be determined.No additional clinical sequelae were provided and the patient is expired.
Additional Manufacturer Narrative
Updated post completion of investigation.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: 10755651
• Report Number: 9612164-2020-04144
• Device Sequence Number: 19094650
• Product Code: MIH
• UDI-Device Identifier: 00763000100728
• UDI-Public: 00763000100728
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: 12/17/2021
• Device Model Number: VNMF4040C183TU
• Device Catalogue Number: VNMF4040C183TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/02/2020
• 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: Death