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

Catalog Number UNK FLEXNAV DS

Device Problems Retraction Problem (1536); Material Deformation (2976); Positioning Problem (3009)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2024, a 29mm navitor valve was selected for implant with an unknown flexnav delivery system.The patient presented with low blood pressure.The patient's native annulus measured 28.8mm diameter and it was noted there was slight calcification.A pre-dilation with balloon aortic valvuloplasty (pre-bav) procedure was completed with a 25mm balloon.During anchoring attempts, it was noted the valve kept diving into the left ventricle.It was thought this was due to the low calcification and pre-bav.The navitor valve was recaptured two times and on the third attempt, it was noticed the flexnav catheter was damaged due to the retraction attempt.Details of the damage are unavailable.A decision was made to remove the valve and delivery system.A 29mm non-abbott valve was implanted instead.No adverse patient consequences were reported.

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• 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: 19013021
• MDR Text Key: 339206359
• Report Number: 2135147-2024-01416
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/01/2024

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: UNK FLEXNAV DS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• 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