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

Model Number	VNMC3737C182TU
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802)
Date of Event	03/14/2020
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 endovascular treatment of a unknown sized ruptured abdominal aortic aneurysm.It was reported that the aneurysm had ruptured due to a type iiia endoleak.There was thought to be a separation between the (main body and cuff) from a previous endovascular repair with a non-mdt device.The physician felt that the patient would not survive and open repair so it was decided to use the valiant navion to bridge the two non-mdt graft components.It was reported that the physician placed the graft too high and was not able to get the distal seal into the main body of the non-mdt graft.The physician tried ballooning and pulling down the navion but the internal stents of the non-mdt grafts prevented downward movement.It was then decided to proceed with a open repair.The physician was unable to get proximal control of the graft but the patient subsequently went into cardiac arrest and expired.As per the physician the cause of the event was because the previously implanted non mdt stent graft made it difficult to see the navion device and subsequently it was implanted too proximally.No additional clinical sequelae were provided and the patient is expired.
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: 9848615
• Report Number: 9612164-2020-01214
• Device Sequence Number: 2967695
• Product Code: MIH
• UDI-Device Identifier: 00763000101060
• UDI-Public: 00763000101060
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 04/30/2020

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: 08/14/2021
• Device Model Number: VNMC3737C182TU
• Device Catalogue Number: VNMC3737C182TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 04/30/2020
• 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
• Patient Age: 72 YR