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

Model Number	VNMF3131C229TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Dyspnea (1816)
Date of Event	12/08/2019
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 system was implanted in a patient for the endovascular treatment of a 200mm diameter thoracic aortic dissection.It was reported that the patient presented with abdominal pain and a type a dissection which extended to the descending thoracic aorta was diagnosed.The patient was prepped for repair and during ct scan, it was noted that the visceral vessels were not patent.It was decided to place a stent graft in the descending aorta to re-establish flow to the visceral vesselsand ivus was used to obtain the true lumen.The valiant navion was placed distal to the subclavian artery and post angiogram still showed no flow to the visceral vessels.Stents were then placed in the celiac and sma to successfully re-establish flow.Lactate levels were elevated post-op but began to decrease two days later and so the patient was extubated and seemed alert and orientated.The next day, the patient became short of breath while sitting and died.The physician said that the ascending aorta had ruptured and that it had been planned to repair this the next day after the patient died.As per the physician, the cause of the event was anatomy related due to the complex thoracic dissection.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
It was reported that the physician had intended to repair the type a dissection during the index procedure and repair the type b dissection at a later time.However, the patient was complaining of severe abdominal pain and so the physician decided to repair the descending dissection first, to re-establish blood flow to the bowel.The navion stent graft was placed in the true lumen, at the intended target.However, it was noted that the dissection would not be resolved until the type a dissection was repaired.It was noted that the patient was recovering well from the bowel ischemia.The patient was scheduled for repair of the type a because their bowel was stable.The planned surgery was to repair the ascending aorta and place a surgical graft to the navion to complete the repair.It was reported that the patient death was not related to the stent graft.According to the physician, the cause of death was related to the rupture of the ascending dissection.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: 9465604
• Report Number: 9612164-2019-05158
• Device Sequence Number: 4130527
• Product Code: MIH
• UDI-Device Identifier: 00763000100612
• UDI-Public: 00763000100612
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/10/2020

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: 03/04/2021
• Device Model Number: VNMF3131C229TU
• Device Catalogue Number: VNMF3131C229TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 12/14/2019
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/10/2020
• 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: Death
• Patient Age: 73 YR