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

Catalog Number FNAV-DS-LG

Device Problems Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 07/14/2023

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) 2023, a 27mm navitor valve was chosen for implant using a flexnav delivery system.The valve was prepared and loaded as recommended in the instructions for use (ifu).The delivery system was inserted but was unable to be advanced pass the bifurcation.After the delivery system was removed, there was damage noted to the outer valve capsule.The blue capsule marker band was frayed.There was no issue with the 27mm navitor valve.Both the valve and delivery system were replaced with another 27mm navitor valve and flexnav delivery system, and the procedure was successfully completed without any further issues.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient status was reported as stable.

Event Description

N/a.

Manufacturer Narrative

An event of advancement difficulty through patient anatomy and catheter damage was reported.The device was returned for analysis.There were scratches and flaring of the valve capsule.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on available information, the cause of the reported event appears to be due to damage during advancement.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 17481043
• MDR Text Key: 320606726
• Report Number: 2135147-2023-03475
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031389
• UDI-Public: 05415067031389
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• 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: 9003426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2023
• 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
• Patient Age: 76 YR