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

Model Number NVTR-25

Device Problem Separation Problem (4043)

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

Event Date 10/20/2022

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, a 25mm navitor valve was selected for implantation using a small flexnav delivery system.During the procedure, while deploying the valve, the valve failed to separate from the delivery system due to a retaining tab remaining attached.It was attempted to retract the valve, but that was unsuccessful.An attempt to rotate the delivery system slightly was also unsuccessful.The delivery system was unable to be retracted from patient anatomy, and a sternotomy was performed to explant the delivery system and valve.A new 25mm epic valve was implanted successfully.The patient is reported to be stable.The patient remained hemodynamically stable throughout the procedure.No additional information was provided.

Manufacturer Narrative

An event of the valve failing to separate from the flex nav delivery system due to a retaining tab remaining attached was reported.The device was returned to abbott, and the investigation confirmed that the retainer tabs of the valve were bent.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications, including passing inspections to confirm there was no damage or bends to the valve stent.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to the labeling design or manufacturing of the device.

• 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: 15811114
• MDR Text Key: 303796579
• Report Number: 2135147-2022-02077
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: 05415067031587
• 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: 02/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NVTR-25
• Device Catalogue Number: NVTR-25
• Device Lot Number: 8649419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2022
• 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: SMALL FLEXNAV DELIVERY SYSTEM, FNAV-DS-SM, 8441478
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 73 KG