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

Model Number	VNMC4343C95TU
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Renal Failure (2041); Injury (2348)
Date of Event	10/23/2019
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 was implanted in a patient as a proximal extension, for the endovascular treatment of an thoracoabdominal aortic aneurysm.The mid to distal descending thoracic aorta measuring 80mm at its greatest dimension.The patient was also treated for a infrarenal and external aneurysm measuring 60mm at its greatest dimension.The case was a physician sponsored ide.It was reported that during the implant procedure, the device was implanted successfully.However, during removal of the delivery system, it became caught on a suprarenal stent and was kinked.This was resolved by ballooning the stent graft and relining it with another navion device.The investigator assessed the cause of the event was possible due to be an operator error and not a device malfunction.Three adverse events have been further reported: intra-abdominal hemorrhage which is confirmed as resolved with sequelae, acute kidney injury which is reported as ongoing and left kidney infarct which is also ongoing.Per the investigator the cause of these adverse events is not known the relationship of these events to the navion device.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Additional information received: it was confirmed that an additional valiant navion stent graft and two endurant ii stent graft limbs were also implanted during the procedure.It was reported that the physician does not believe the navion or endurant devices themselves had anything to do with the adverse outcomes.The physician stated that the event was more of a byproduct of a wire perforation at the index procedure and the other events were sequelae from the original complication.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: 9352846
• Report Number: 9612164-2019-04828
• Device Sequence Number: 19530654
• Product Code: MIH
• UDI-Device Identifier: 00763000101138
• UDI-Public: 00763000101138
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

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: 07/30/2021
• Device Model Number: VNMC4343C95TU
• Device Catalogue Number: VNMC4343C95TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/12/2019
• 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