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

Catalog Number NVTR-29

Device Problems Difficult to Fold, Unfold or Collapse (1254); Off-Label Use (1494)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Vascular Dissection (3160)

Event Date 01/17/2024

Event Type  Death  

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 a (b)(6) 2024, a 29mm navitor valve was chosen for implant.The patient had a bicuspid aortic valve with severe calcification.A pre-implantation balloon-aortic valvuloplasty (bav) was performed, using a 22mm non-abbott balloon.During deployment, the valve was noted to be under expanding.It was decided to release the valve while under expanded.Post-bav was performed with a 25mm non-abbott balloon, resulting in dissection of the ascending aorta.The patient had a brady-asystolic heart rhythm and remained with medical treatment for observation.The patient expired on (b)(6) 2024 due to brady-asystolic heart rhythm.

Manufacturer Narrative

An event of valve underexpansion, off-label use, and death was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Information from the field indicated that the patient had a bicuspid aortic valve with severe calcification, the valve was under expanding after a pre-implantation balloon-aortic valvuloplasty (bav) was performed, and a post-bav was performed and resulted in dissection of the ascending aorta.The patient later passed away.The event was further reviewed by an abbott senior director of medical affairs.Based on all available information, a cause for the reported valve underexpansion could not be conclusively determined.It is possible that patient condition (severe calcification) contributed to this event.However, this cannot be confirmed.The reported death appears to be related to a combination of aortic root dissection noted after post-dilation in addition to a brady/asystole rhythm, per the medical review.The reported off-label use is due to the valve being used on a patient with a bicuspid aortic valve.

• 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: 18714295
• MDR Text Key: 335489979
• Report Number: 2135147-2024-00700
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: PE
• 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
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NVTR-29
• Device Lot Number: 9116468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• 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
• Treatment: LARGE FLEXNAV DELIVERY SYSTEM FNAV-DS-LG, (B)(6)
• Patient Outcome(s): Death; Other
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 53 KG