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

Model Number	VNMC3434C223TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	12/13/2019
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 an acute incidence of spinal cord ischemia occurred.The ischemia was resolved after raising the patient's blood pressure and a spinal drain.The patient is doing well and is symptom free.The cause of the event is unknown.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film analysis: the exact cause of the acute spinal cord ischemia occurring during implant, which later resolved after raising the patient¿s blood pressure and adding a drain, could not be determined from the pre-implant ct¿s returned.Images during implant were not returned, and post-implant ct¿s showing the stent graft in-vivo configuration also were not available.Analysis of the returned films did not reveal any anatomical characteristics that could explain the reported event.It is unknown if the widespread thrombus observed within the thoracic, or some other anatomical/physiological factor, may have led to the ischemia.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: 9568537
• Report Number: 9612164-2020-00167
• Device Sequence Number: 16597837
• Product Code: MIH
• UDI-Device Identifier: 00763000101039
• UDI-Public: 00763000101039
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 02/10/2020

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: 09/18/2021
• Device Model Number: VNMC3434C223TU
• Device Catalogue Number: VNMC3434C223TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/10/2020
• 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: Other; Required Intervention
• Patient Age: 76 YR