MAUDE Adverse Event Report: ABBOTT MEDICAL NAVITOR; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number NVTR-27

Device Problems Migration or Expulsion of Device (1395); Perivalvular Leak (1457); Central Regurgitation (4068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: NAVITOR
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15992059
• MDR Text Key: 305581940
• Report Number: 2135147-2022-02590
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: 05415067031594
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NVTR-27
• Device Catalogue Number: NVTR-27
• Device Lot Number: 8564286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention