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

Model Number	VNMF4646C62TU
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Off label use due to use of device in abdominal area.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 53mm diameter abdominal aortic aneurysm.It was noted that the patient had previously had a gore stent graft implanted which had migrated due to disease progression.It was observed that the aorta measured 41mm just below the renals.Mild vessel calcification was noted.It was reported that during deployment of the cuff, the graft migrated proximally about 2cm covering both renal arteries.At this point the bare stents had not been deployed and so the graft was able to be pulled down to below the renals to allow renal perfusion.A second valiant navion covered seal 46mm graft was placed below the renal arteries to bridge the gap between the first navion and the original gore graft.6 heli-fx endoanchors were placed to prevent the stent graft from riding up.On final angiogram, both renal arteries were perfused and no endoleak was seen.Post op day one the patient has good kidney function and doing well per the physician.As per the physician, the cause of the event is unknown but commented the cuff performed differently than expected by jumping up to 2cm with downward pressure.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
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: 8543381
• Report Number: 2953200-2019-00541
• Device Sequence Number: 16235125
• Product Code: MIH
• UDI-Device Identifier: 00763000100780
• UDI-Public: 00763000100780
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2020
• Device Model Number: VNMF4646C62TU
• Device Catalogue Number: VNMF4646C62TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR