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

Model Number NVTR-29

Device Problems Migration or Expulsion of Device (1395); Separation Problem (4043)

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

Event Date 12/20/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, a 29mm navitor valve was selected for implantation using a flexnav delivery system.During the procedure, as the delivery system was being retracted through the ascending aorta, it was noticed that one of the retainer tabs of the valve was not released from the delivery system.The valve then migrated out of the annulus and did not block any arteries.A second 26mm non-abbott valve was placed.Patient is reported to be stable.The patient remained hemodynamically stable throughout the procedure.Delay to procedure considered not clinically significant.There were no adverse patient effects.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

An event of device migration and one tab of the valve not disconnecting from the delivery system was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection.Operation was performed and the product met all specifications.Based on the available information, the cause of the reported event could not be conclusively determined.

• Brand Name: NAVITOR TRANSCATHETER AORTIC VALVE
• 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: 16133191
• MDR Text Key: 307032067
• Report Number: 2135147-2023-00154
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031600
• UDI-Public: 05415067031600
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NVTR-29
• Device Catalogue Number: NVTR-29
• Device Lot Number: 8646384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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
• Treatment: FLEXNAV DELIVERY SYSTEM, FNAV-DS-LG, 8709765; NAVITOR LOADING SYSTEM, NVTR-LS-LG, 8589146
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female