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

Model Number NVTR-27

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/09/2023

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) 2023, a 27mm navitor valve was chosen for implant.The annulus perimeter was measured to be 77mm and it was noted that the patient had a horizontal aorta.A pre-dilation was performed using a 23mm non-abbott balloon.The valve was partially deployed and re-captured three times due to difficulty positioning the valve in the patient anatomy and instability of the pig-tail catheter.On the third attempt at positioning, the valve was deployed at 1mm and released at 3mm above the annulus.After it was released, the valve migrated above the aortic annulus.The valve was not blocking the coronary arteries but, a lasso (snare) was used to raise the valve further so it would not block the coronary arteries in the future.A second 27mm navitor valve was then implanted and released in an optimal position.A minimal residual leak was present after the valve-in-valve procedure was performed and the coronary arteries were not blocked.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient was discharged to home.No additional information was provided.

Manufacturer Narrative

An event of device migration was reported.A returned device assessment could not be performed as the device remains implanted and 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 information received, the cause of the reported incident could not be conclusively determined.Please note per the instructions for use, " once the valve is fully deployed, repositioning and retrieval of the valve is not possible.Attempted retrieval (e.G., use of a guidewire, snare, or forceps) may cause aortic root, coronary artery, and/or myocardial damage." also- " caution: do not re-sheath the valve more than two times.If additional positioning attempts are needed, completely re-sheath the valve and remove the valve from the patient.Use a new valve and delivery system to complete the procedure.".

• 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: 16668673
• MDR Text Key: 312587726
• Report Number: 2135147-2023-01456
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8688087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 06/13/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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