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

Model Number	VNMF3434C174TU
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Film evaluation summary: the reported stent graft kink was confirmed; however, the exact cause could not be determined from the limited films provided.Ct¿s prior to implant were not available for review; therefore a complete assessment of the patient¿s anatomy could not be performed.Images during implant as well as additional ct¿s post-implant were also not available.The returned comparative images at 1-month & 7-months post-implant appear to show that there has been a slight decrease in the taa diameter, with a change in the stent graft appearance which is now more angulated & gothic-shaped.This has resulted in the stent graft becoming kinked, has led to an increase of the linear overlap between the kinked stents along the inner curvature, and also may have resulted in a slight reduction of the flow lumen diameter at the kinked location.It appears that the mid-length of the device at the level of the top of the arch has shifted more superiorly within the unapposed taa, while the proximal and distal graft margins appeared to have remained in their approximate same implanted position, thereby resulting in the stent graft kink.It is also possible that the stent graft interaction with the elephant trunk may have also contributed to the kink.Outside physician film review: i have had an opportunity to review the images for the patient.Clearly there has been some regression of the taa size that may be resulting on remodeling of the graft.Looking at the ascending as well, it appears to have been forced upwards as a result of the remodeling.The graft does not appear to have changed positions and looks circumstantially apposed.Would recommend either taking pressure gradients or exercise abi's.If there is no gradient, would recommend re-scanning in 6-months.(b)(6).If information is provided in the future, a supplemental report will be issued.
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 an unknown size thoracic aortic aneurysm.It was reported that when the patient returned for follow-up on an unknown date it was noted that the aneurysm had decreased in size but the stent graft was now kinking.It was reported that there has been no clinical decline for the patient and they remained asymptomatic.It was reported that in this case the device was used in a staged repair and landed into the elephant trunk.It was reported that is thought that aneurysm remodeling had occurred since the aneurysm has now decreased in size, and because the elephant trunk is now noted to be floppy the stent graft is now kinking slightly.As per the physician the cause of the event can not be determined.No additional clinical sequalae were reported and the patient will be monitored.

• 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: 9631321
• Report Number: 9612164-2020-00417
• Device Sequence Number: 3414380
• Product Code: MIH
• UDI-Device Identifier: 00763000100643
• UDI-Public: 00763000100643
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/20/2020

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: 01/08/2021
• Device Model Number: VNMF3434C174TU
• Device Catalogue Number: VNMF3434C174TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR