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

Catalog Number PRT-NG-27

Device Problems Perivalvular Leak (1457); Off-Label Use (1494); Malposition of Device (2616)

Patient Problem Heart Block (4444)

Event Date 02/02/2024

Event Type  Injury  

Event Description

Clinical information: (b)(6).It was reported that on (b)(6) 2024, a 27mm navitor valve was chosen for implant using a flexnav delivery system during a transcatheter aortic valve implantation.A 25mm non-abbott surgical aortic valve was previously implanted, so the navitor valve implantation was an off-label valve-in-valve procedure.There was no calcification extending beneath the aortic annular plane in the interventricular septum.During the procedure, the navitor valve was successfully implanted.There were no deployment or retraction difficulties.The final implant depth on the non-coronary cusp (ncc) was 3mm and on the left coronary cusp (lcc) was 8mm, which was an acceptable depth for the physician.A post-implant balloon aortic valvuloplasty (bav) was performed with a 23mm non-abbott balloon due to residual gradient of 15mmhg indicating a perivalvular leak.The post implant mean aortic valve gradient was 11mmhg, and there was no perivalvular leak.On (b)(6) 2024, the patient experienced a first degree heart block on electrocardiogram (ecg).No treatment was required.The patient status was reported as stable.

Manufacturer Narrative

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

Manufacturer Narrative

An event of perivalvular leak and first degree heart block was reported.It was also reported that a post-implant balloon aortic valvuloplasty was performed and post implant mean aortic valve gradient was 11 mmhg, and there was no perivalvular leak.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 available information, the cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Information from field indicated that a 25 mm non-abbott surgical aortic valve was previously implanted, and this was a valve in valve procedure.Please note that per the instructions for use, "the navitor¿ valve is designed to be implanted in the native calcific aortic heart valve without open heart surgery and without concomitant surgical removal of the failed native valve.".

Event Description

Clinical information: crd_1003 - vantage, patient site id: (b)(6).It was reported that on (b)(6) 2024, a 27mm navitor valve was chosen for implant using a flexnav delivery system during a transcatheter aortic valve implantation.A 25mm non-abbott surgical aortic valve was previously implanted, so the navitor valve implantation was an off-label valve-in-valve procedure.There was no calcification extending beneath the aortic annular plane in the interventricular septum.During the procedure, the navitor valve was successfully implanted.There were no deployment or retraction difficulties.The final implant depth on the non-coronary cusp (ncc) was 3mm and on the left coronary cusp (lcc) was 8mm, which was an acceptable depth for the physician.A post-implant balloon aortic valvuloplasty (bav) was performed with a 23mm non-abbott balloon due to residual gradient of 15mmhg indicating a perivalvular leak.The post implant mean aortic valve gradient was 11mmhg, and there was no perivalvular leak.On (b)(6) 2024, the patient experienced a first degree heart block on electrocardiogram (ecg).No treatment was required.The patient status was reported as stable.

• 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: 18798299
• MDR Text Key: 336508564
• Report Number: 2135147-2024-00897
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P190023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PRT-NG-27
• Device Lot Number: 8489944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2022
• 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: 84 YR
• Patient Sex: Male
• Patient Weight: 75 KG