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

Catalog Number NVTR-23

Device Problems Difficult to Fold, Unfold or Collapse (1254); Migration or Expulsion of Device (1395); Perivalvular Leak (1457); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/10/2024

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 10 january 2024, a 23mm navitor valve (sn: (b)(6) was chosen for implant, using a small flexnav delivery system (lot: 8892912) for a transcatheter aortic valve implantation.This was a valve-in-valve procedure where the navitor valve was to be implanted into a previously implanted 21mm non-abbott valved graft.During initial placement of the valve, there was difficulty crossing the aortic arch, but was successful.It was believed to be difficult due to the location where the surgical aortic root valved graft was sewn to the native aorta.The patient had a somewhat tortuous anatomy.Physician proceeded to deploy valve approximately 0-1 mm below the base of the previously implanted surgical valve.High gradient and valve underexpansion were present, so a post balloon aortic valvuloplasty (bav) was performed.The stent frame of the valve became supra annular after balloon expansion due to the stent frame shortening the valve above the annulus as it expanded.Physician decided to snare the valve and implant a second valve.A new 23mm navitor valve (sn: (b)(6) was prepared with a new small flexnav delivery system (lot: 8684036).Physician continued to have difficulty crossing arch again, which ultimately caused a tear at the anastomosis of the native aorta and graft from aortic root replacement.The valve was deployed in the aortic arch in hopes to seal the tear.Physician requested a third 23mm navitor valve (sn: (b)(6) and small flexnav delivery system (lot: 8684036) to attempt to seal the tear but was unable to deploy that valve, potentially from the curvature in the valve capsule while trying to deploy in the aortic arch.Team agreed not to open patient¿s chest and subsequently the patient expired on the day of procedure due to bleeding out in the chest cavity.The patient was considered to be extreme risk prior to procedure and was not an open-heart surgery candidate.

Manufacturer Narrative

An event of off-label use, improper or incorrect procedure or method, valve underexpansion, device migration, and paravalvular leak was reported.Possible contributing factors for valve migration are intra-procedural difficulties, implant depth, annular calcium distribution, and deployment or retraction difficulties.Possible causes for paravalvular leak are sizing of the valve, implant depth, calcium distribution, deployment difficulties and inadequate radial forces.Information from the field indicated that the valve was chosen for a valve-in-valve procedure, paravalvular leak and valve underexpansion was present after deployment, the stent frame shortened above the valve after balloon expansion, and the valve was snared.The implant depth was 0-1mm from the base of the surgical aortic valve, there was no calcium at the location due to the procedure (valve in valve), and there were no deployment or retraction difficulties.It was noted that it is believed the migration is due to the post-dilatation.Based on the available information, the root cause of the migration appears to be related to procedural conditions (post-dilatation).The root causes of the valve underexpansion and paravalvular leak could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Please note per the instructions for use (ifu), "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." additionally, the ifu states, "the safety, effectiveness, and durability of a navitor/navitor titan valve implanted within a surgical or transcatheter bioprosthesis have not been demonstrated." information from the field indicates that it is unknown if the physician was aware of these warnings.The deviations from the ifu and its associated potential adverse events will be addressed in the letter requested by the account.

• 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: 18624269
• MDR Text Key: 334335679
• Report Number: 2135147-2024-00453
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NVTR-23
• Device Lot Number: 8815806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• 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: 1ST FLEXNAV DS, FNAV-DS-SM, LOT 8892912; 1ST NAVITOR VALVE, NVTR-23, SN (B)(6).; 2ND FLEXNAV DS, FNAV-DS-SM, LOT 8684036; 2ND NAVITOR VALVE, NVTR-23,(B)(6).; 3RD FLEXNAV DS, FNAV-DS-SM, LOT 8684036; 3RD NAVITOR VALVE, NVTR-23, SN (B)(6).
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 57 KG