MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXNAV DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Catalog Number FNAV-DS-LG

Device Problems Retraction Problem (1536); Material Deformation (2976)

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

Event Date 11/17/2023

Event Type  malfunction  

Event Description

It was reported that on(b)(6) 2023, a 29mm navitor valve was chosen for implantation utilizing a large flexnav delivery system.The navitor was advanced to the valve.During first deployment, position was too high so it was decided to recapture and reposition.During recapture, there was difficulty retracting the valve in the capsule.Both the deployment and micro adjustment wheel was used but bottomed out and were unsuccessful.Kinked portions of the valve capsule were noticed proximally and distally.The flexnav was straightened and with great caution were able to get most of the navitor valve back into the valve capsule where it was removed from the patient.Although, 5-10% of the valve remained outside the valve capsule.There was no issue with the navitor valve itself and retainer tabs remained in place.A replacement 29mm navitor valve and replacement large flexnav delivery system were used to complete the procedure.There were no reported patient consequences and the patient remained hemodynamically stable throughout the procedure.There was a delay that resulted in no patient effects.The patient is reported to be recovering.

Manufacturer Narrative

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

Manufacturer Narrative

An event of difficulty retracting the valve in the capsule and kinking in valve capsule was reported.The investigation at abbott found that the valve capsule was deformed damaged and the inner shaft was noted to contain several kinks throughout which precluded using it to perform functional testing.No other anomalies were noted with the device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Three images from field appeared to show distal end of delivery system having a valve in loaded position, the valve capsule appeared kinked and deformed.Information from field indicated that the valve position was too high and there was difficulty retracting the valve in the capsule.The cause of the reported retraction problem could not be conclusively determined, however the damage noted to the valve capsule is consistent with difficulty retracting the valve.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: FLEXNAV DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18310676
• MDR Text Key: 330668989
• Report Number: 2135147-2023-05448
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031389
• UDI-Public: 05415067031389
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/12/2024

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 Catalogue Number: FNAV-DS-LG
• Device Lot Number: 8857582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2023
• 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: 29 MM NAVITOR VALVE NVTR-29 SERIAL: (B)(6).
• Patient Age: 88 YR
• Patient Sex: Male