MAUDE Adverse Event Report: ABBOTT MEDICAL NAVITOR; 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 Problems Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/22/2022

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 2022, a 27mm navitor valve was chosen for implant using a large flexnav delivery system.The patient perimeter was sized at 73mm.A pre-dilatation balloon aortic valvuloplasty (bav) was performed with a 22mm unknown manufacturer balloon.The valve was attempted to implant at a depth of 3mm in the non-coronary sinus.When the valve was 80% deployed, the depth in the left sinus was at 6mm.The user paused and removed the tension from the guide before releasing the valve.When the valve was released, the valve began slipping from the non-coronary sinus to the ascending aorta resulting in severe aortic insufficiency (iao).The patient experienced hypotension due to iao during the procedure.A snare was used to raise the migrated valve into the ascending aorta to leave the coronary arteries free.A 23mm non-abbott valve was then implanted without problems.There was no clinically significant delay in the procedure patient was reported as stable.

Manufacturer Narrative

An event of a valve migrating and embolizing the ascending aorta 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 that the product met all specifications, including specifications for radial force.Information from the field indicated that the at 80% of the implant, the projection was changed to see the depth in the left sinus and it was 6mm.The field indicated that the user paused and removed the tension from the guide before releasing the valve.Based on the available information, the root cause of the reported event of valve migration could not be conclusively determined but could have been related to the amount of tension in the delivery system.There is no indication of a product quality issue with respect to the labeling design or manufacturing of the device.Please note, per the navitor transcatheter aortic valve implantation system instructions for use, "post-implantation precautions: 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.

• 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: 15964793
• MDR Text Key: 305335128
• Report Number: 2135147-2022-02505
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: 05415067031594
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• 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: 03/07/2023
• 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
• Patient Age: 87 YR
• Patient Sex: Female