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

Model Number	VNMC3737C182TU
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: it was confirmed that the trigger on the device appeared to fully engaged when attempting to deploy.It was also confirmed that no cause of the event has been established as per the physician.Device evaluation summary: the delivery system returned with the external slider and rapid release trigger in the home position.There was no damage observed to the delivery system.There was no restriction observed retracting the graft cover using the external slider and the trigger.The handle was disassembled, and the trigger mechanism removed and dissembled.There was no anomaly observed to the clips which would have contributed to the difficulties encountered by the physician.The reported deployment/expansion issues were not confirmed through analysis.If information is provided in the future, a supplemental report will be issued.
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 286mm thoracic aortic dissection.It was reported that during the index procedure the blue screw gear was rotated to deploy the device vnmc3737c182tu.It was reported that the blue slider would rotate but did not move or deploy the device.It was also reported that the slider made clicking noise when rotated.The trigger was noted to have been forward during the rotations.The physician was able to use the quick release trigger to deploy the device.The cause of the event is unknown.No additional clinical sequelae were reported and the patient is fine.

• 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: 9557049
• Report Number: 9612164-2020-00105
• Device Sequence Number: 11323998
• Product Code: MIH
• UDI-Device Identifier: 00763000101060
• UDI-Public: 00763000101060
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/26/2020

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 Expiration Date: 09/23/2021
• Device Model Number: VNMC3737C182TU
• Device Catalogue Number: VNMC3737C182TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1