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

Model Number	VNMF3434C97TU
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Ischemia (1942); Occlusion (1984)
Date of Event	12/10/2019
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 system was implanted in a patient for the endovascular treatment of a thoracic aortic ulcer.It was reported that during the index procedure, the angiogram was performed to mark the level of the left carotid.While positioning and deploying the device, the patient awoke and moved and the left carotid was unintentionally covered by the stent graft.A cutdown of the carotid was performed to expose it and a covered stent was placed as a snorkel to re-establish flow to the vessel.The left arm was repaired with a vein graft.On waking the patient coded, cpr was performed and they recovered by the left arm was ischemic.A carotid to brachial bypass was the performed to fix the blood flow to the arm and on last update the patient is alert and moving their extremities.As per the physician, the cause of the event is anatomy related for the ischemic arm and because the patient awoke during placement of the valiant navion.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
It was reported that the procedure was performed with the patient awake, due to their medical condition.During deployment of the device, the patient was stimulated when the stent graft was inserted into their groin, which caused the patient to move.This movement caused the marks on the screen, which indicated the intended landing zone, to be inaccurate.The physician deployed the stent graft as per the screen markings, however due to the inaccuracy the stent graft was inaccurately deployed.The left brachial artery was damaged by the placement of a sheath in the artery.The subclavian was covered and the patient's arm became ischemic due to lack of blood flow and arterial damage.The carotid-brachial bypass was preformed to bypass the injury and re-establish flow to the arm.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: 9465778
• Report Number: 9612164-2019-05159
• Device Sequence Number: 14219592
• Product Code: MIH
• UDI-Device Identifier: 00763000100636
• UDI-Public: 00763000100636
• 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,Followup
• Report Date (Section B): 01/10/2020

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: 11/21/2020
• Device Model Number: VNMF3434C97TU
• Device Catalogue Number: VNMF3434C97TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/14/2019
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/10/2020
• 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: 66 YR