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

Catalog Number NVTR-29

Device Problems Migration or Expulsion of Device (1395); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Premature Separation (4045)

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

Event Date 02/12/2024

Event Type  Injury  

Event Description

It was reported that on 12 february 2024, a 29mm navitor valve was chosen for a procedure in a patient with bicuspid aortic valve (bav) type 1 using a 19f flexnav delivery system.The annular dimensions of the native valve were area 515mm2, perimeter 80.8mm, diameter average 25.5mm and there were 851mm agatston units of calcium to allow anchoring of the device.During procedure, the retainer tabs detached inside the delivery system and the valve was implanted after five recaptures.After the release, the valve was embolized.The valve was snared and pulled back to ascending aorta, and a new 26mm non-abbott valve chosen and implanted.The physician mentioned the cause of migration was retainer tabs detached inside the delivery system.The patient was reported stable and discharged from the hospital.

Manufacturer Narrative

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

• 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: 18954014
• MDR Text Key: 338306490
• Report Number: 2135147-2024-01305
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031600
• UDI-Public: 05415067031600
• Combination Product (y/n): N
• Reporter Country Code: KZ
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NVTR-29
• Device Lot Number: 9009567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2023
• 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
• Patient Age: 64 YR