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

Catalog Number FNAV-DS-SM

Device Problem Material Deformation (2976)

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

Event Date 12/09/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It as reported that on (b)(6) 2023, a 25mm navitor valve was chosen for implant with a small flexnav delivery system.It was reported an unknown 18f introducer sheath was used for the procedure.It was reported that while entering the system through the patient's right femoral artery, there was an "overposition of the capsule over the nose cone" causing a "tooth" deformation at the lip of the valve capsule.A decision was made to replace the delivery system for a new small flexnav delivery system.The 25mm navitor valve was successfully implanted.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay in the procedure due to this event.The patient status was reported stable and discharged.

Manufacturer Narrative

An event of material deformation was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The complaint history was reviewed, and no related incidents were found for this lot.Information from the field indicated that during insertion, the capsule was "overpositioned over the nose cone", which presented a "tooth" in the delivery system and caused a potential for vessel dissection.Based on available information, a root cause for the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Na.

• 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: 18431586
• MDR Text Key: 331931980
• Report Number: 2135147-2024-00009
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067031372
• UDI-Public: 05415067031372
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 01/10/2024

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-SM
• Device Lot Number: 8939608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2023
• 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: NAVITOR VALVE, NVTR-25
• Patient Sex: Male