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

Model Number NVTR-25

Device Problems Difficult to Fold, Unfold or Collapse (1254); Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/01/2022

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 (8529487).The perimeter was measured as 72.8mm.The device size was chosen based on the calcification of the valve annulus.There was tortuosity encountered when attempting to access the blood vessel to implant the valve.A prebav was performed using an 18mm non-abbott balloon.It was seen via echocardiogram that there was some valve movement after the prebav and atrial regurgitation remained mild.The device was then placed at 5mm.After it was released, the valve could not expand.The device was removed from the patient with the delivery system, and both were discarded.Another prebav was completed using a 20mm balloon.A new delivery system (8674405) and 25mm navitor valve (19429674) were chosen for implant.The valve was deployed at 5mm again.After 5-7 minutes the valve expanded to 80% and the device was released from the delivery cable.As the delivery system was being removed, the stent on the non-coronary cusp side came off and the valve popped out of the patient's annulus.A snare was opened and intended to snare the valve away from the coronary artery ostium.However, the device was difficult to ensnare so the snare procedure was aborted.It was observed that the valve traveled between 15-20mm and stopped moving at the sinotubular junction (stj).It was determined that there was no risk of coronary artery occlusion.A non-abbott valve was then chosen to implant in a valve in valve procedure.This valve also did not expand well, and it was suspected that the size of the implantation site was insufficient.The valve was recaptured three times, but the result did not change.The user was concerned that the valve would be displaced again when attempting to remove the nosecone, so the second valve was not implanted.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay.The patient was reported as stable.

Manufacturer Narrative

An event of the valve not fully expanding after the release was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and that the product met all specifications, including specifications for radial force.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to 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: 16037514
• MDR Text Key: 308374406
• Report Number: 2135147-2022-02688
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: 05415067031587
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• 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: 8602028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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
• Patient Age: 95 YR
• Patient Sex: Female
• Patient Weight: 33 KG