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

Model Number NVTR-25

Device Problems Improper or Incorrect Procedure or Method (2017); Contamination /Decontamination Problem (2895)

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

Event Date 12/13/2022

Event Type  malfunction  

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 chosen for implant using a small flexnav delivery system.During the procedure, the user had to reposition the valve several times due to the calcium on the aortic ring.The valve was deployed and re-sheathed a total of four times.The valve was removed and attempted to reassemble.When the valve was being cleaned in physiological serum and reassembled outside of the patient, a white tissue was noticed in the serum.It was unknown whether the tissue was from the patient or the navitor valve.A replacement 25mm navitor valve was then chosen for implant.The replacement valve was successfully implanted.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay.The patient was reported as stable.No additional information was provided.

Manufacturer Narrative

An event of white tissue on the valve could not be confirmed.The device was returned to abbott for investigation, the valve was grossly examined, and there was no evidence of foreign material found on the valve.One picture was received from the field which appeared to show the white tissue in the serum.The field indicated the valve was resheathed four times which is against the ifu.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications which include the inspection of the valve.Based on the available information, the root cause of the reported incident of white tissue on the valve could not be conclusively determined but it could be from the patient.Per the instructions for use, implantation precautions: "do not re-sheath the valve more than two times prior to final valve release.Additional re-sheath attempts may compromise product performance.".

• 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: 16116104
• MDR Text Key: 308448399
• Report Number: 2135147-2023-00081
• 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: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NVTR-25
• Device Catalogue Number: NVTR-25
• Device Lot Number: 19499499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2022
• 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