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

Model Number	VNMC3737C52TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intimal Dissection (1333); Death (1802); Perforation of Vessels (2135)
Date of Event	06/08/2020
Type of Reportable Event	Death
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 used in the endovascular treatment of a 79mm thoracic aortic aneurysm.It was noted that the patients proximal thoracic aortic diameter was 32mm.It was reported that during the index procedure, the physician rapidly paced the patient's blood pressure to 180 and deployed the stent graft to the intended location to cover the aneurysm.The patient briefly lost her pulse and chest compressions were given.The patient recovered but the physician placed the patient on a pump to help her recover and the device was removed and a 16fr sheath placed in the left femoral access for haemostasis.The patient responded and was taken off the pump and angioram performed showed no endoleak.However, a small, non flow limiting dissection could be seen at the aortic bifurcation.When the 16fr sheath was attempted to be moved, the left common iliac separated form the aortic bifurcation and the patient ruptured.There was no wire access from the left as the pigtail was being used for angiogram and attempts to reengage the wire to place an occlusive balloon were unsuccessful.The patient died.The cause of the event was anatomy related due to the ruptured left iliac transection.No additional clinical sequelae were reported.

• Brand Name: VALIANT NAVION
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• MDR Report Key: 10194019
• Report Number: 9612164-2020-02314
• Device Sequence Number: 19603422
• Product Code: MIH
• UDI-Device Identifier: 00763000101046
• UDI-Public: 00763000101046
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

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: 10/29/2020
• Device Model Number: VNMC3737C52TU
• Device Catalogue Number: VNMC3737C52TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 06/25/2020
• 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: Death
• Patient Age: 48 YR
• Patient Weight: 60