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

Model Number	VNMC2828C182TU
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intimal Dissection (1333); Death (1802); Occlusion (1984); Rupture (2208); Blood Loss (2597)
Date of Event	12/30/2018
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 implanted in a patient for the endovascular treatment of a 70mm diameter thoracic aortic aneurysm.There was a pre-operative aneurysm rupture.It was reported that during the index procedure, it was intended to implant the device from the distal edge of left common carotid to the mid descending thoracic aorta.The device was introduced and deployed precisely at the location identified.No additional runs were done prior to deployment.The graft appeared to be perfectly placed, however a post implant run was initiated and it was discovered that the left common carotid had been covered by the stent graft.Left arm access was made and a wire was placed to cross the covered portion of the left common carotid.It was reported that the wire caused a dissection plane necessitating emergent carotid/carotid-carotid/subclavian bypass.The physician commented that the coverage of the left common carotid was likely due to the patient anatomy and not a device issue.The problem was caused by the inadvertent wire placement creating a dissection plane proximal to the left common carotid.It was reported that the patient was doing well in the icu three hours post-op, was alert and moving extremities but then suddenly coded and died of a massive haemorrhage one day post the index procedure.The cause of death was reported post-implant rupture.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
It was reported that the following measurements were taken from ct - 26mm @ lcc, 23mm @ lsa and distal seal zone 23mm.It was reported that the angulation was generally unremarkable.After initial angiogram it was decided to use a 28mm device but after further study, the physician opted for the 28/28/182 instead of the 28/22/173 initially discussed.The thoracic aneurysm was 60+cmm with extravasation around the proximal and mid descending thoracic aorta.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: 8247439
• Report Number: 2953200-2019-00101
• Device Sequence Number: 1593689
• Product Code: MIH
• UDI-Device Identifier: 00763000100964
• UDI-Public: 00763000100964
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2020
• Device Model Number: VNMC2828C182TU
• Device Catalogue Number: VNMC2828C182TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/30/2018
• Supplement Date Received by Manufacturer: 12/30/2018; 01/16/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 01/16/2019; 01/29/2019
• 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: Death; Required Intervention