It was reported that on (b)(6) 2022, a 27mm navitor valve was selected for an implant.The patient had a horizontal aorta with sufficient moderate calcification to allow anchoring of the device.During the procedure, the valve jumped above the aortic ring, causing an aortic leak.The valve was snared into the ascending aorta.A second 27mm navitor valve was implanted to obtain a satisfactory result; no leak was observed post-procedure.The final implant depth of the first navitor valve was 2/3mm.No interaction between the delivery system and the valves were reported.There were no difficulties in deploying the valves.The patient remained hemodynamically stable throughout the procedure.No patient consequences were reported.
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An event of device migration was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications, including meeting specifications for radial force.Possible contributing factors for valve migration are intra-procedural difficulties, implant depth, and annular calcium distribution.Information from field indicated that the valve was at the correct implant depth, there was sufficient calcium for valve anchoring, and that there was tension in the delivery system at the time of deployment due to the patient's horizontal aorta.The patient's horizontal aorta may have contributed to the reported event, however the cause of the device migration could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6: medical device code 1457 (perivalvular leak) removed.Code 4068 (central regurgitation) added.
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