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

Model Number	VNMF4040C223TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Paraplegia (2448)
Date of Event	06/10/2020
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 stent graft was implanted in the patient for the endovascular treatment of a 223mm thoracic aortic dissection.It was noted that the device was implanted from the lsa to the mid descending thoracic aorta.It was reported that post-operatively, after csf drainage was removed a week later, the physician stated that they re-established another csf drain but the patient had paraplegia symptoms.It was noted that the index procedure was performed without issue.As per the physician the cause of the event could not be determined but that the patient had an existing aui and fem-fem and the physician thought that having the previous aaa repair may have contributed to the paraplegia.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Film analysis: the reported paraplegia event could not be assessed on the films provided; therefore the cause of the event could not be fully deter mined.Post-implant ct¿s were not provided for review and so the valiant stent grafts in vivo configuration could not be assessed.A thorough analysis of the abdominal stent graft in vivo configuration could also not be performed and so the contribution of this device to the paraplegia event.It is possible that the observed narrowing of the right iliac artery may have been a factor also.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: 10218218
• Report Number: 9612164-2020-02380
• Device Sequence Number: 14094565
• Product Code: MIH
• UDI-Device Identifier: 00763000100735
• UDI-Public: 00763000100735
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/10/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2020
• Device Model Number: VNMF4040C223TU
• Device Catalogue Number: VNMF4040C223TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/10/2020
• 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: Disability
• Patient Age: 70 YR