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

Model Number	VNMC4646C218TU
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During tevar procedure medtronic valiant navion device malfunctioned during deployment.Portion of handle disassembled, deployment was successful.From the operative note: next, the proximal device a medtronic nevi on a 46 x 46 x 218 mm, was advanced from the left femoral access over the double curve lunderquist wire into the proximal descending thoracic aorta and on sheath successfully.However, with release of the proximal constraining mechanism of the covered seal portion of the device the device was not successfully released.Therefore, the back portion of the delivery system was manually exposed and with multiple movements forward and backward of the inner cannula of the delivery system ultimately the proximal covered seal portion of the device was able to be successfully deployed.The entire delivery system was then successfully removed over the lunderquist wire and a 20 french sheath was advanced over the lunderquist wire into the left common femoral artery.

• Brand Name: VALIANT NAVION
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC VASCULAR; 3850 brickway blvd; santa rosa CA 95403
• MDR Report Key: 8935021
• Report Number: 8935021
• Device Sequence Number: 13607438
• Product Code: MIH
• UDI-Device Identifier: 00763000101190
• UDI-Public: (01)00763000101190(17)210403
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2019
• Report Date (Section F): 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VNMC4646C218TU
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 67
• Date Report Sent to FDA: 08/07/2019