MAUDE Adverse Event Report: ABBOTT MEDICAL REGENT HEART VALVE WITH FLEX CUFF; HEART-VALVE, MECHANICAL

Catalog Number 23AGFN-756

Device Problems Improper or Incorrect Procedure or Method (2017); Physical Resistance/Sticking (4012)

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

Event Date 10/02/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, a 23mm sjm regent heart valve with flex cuff was chosen for implant.The valve was implanted and was confirmed to be well seated.Before the patient was taken off pump, it was noticed the leaflets were sticking and not opening properly.It was decided to remove the device.A replacement 23mm sjm regent heart valve with flex cuff was successfully implanted.The patient is reported to be stable and recovering.There was no adverse patient effect.The patient remained hemodynamically stable throughout the procedure.

Manufacturer Narrative

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

Manufacturer Narrative

An event of the valve leaflets opening and closing abnormally was reported.The device was received for examination and no anomalies were found.The valve was sent for functional testing which confirmed that the valve functioned normally, with the leaflets moving with no asynchronous motion.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• 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: 18007852
• MDR Text Key: 326770060
• Report Number: 2135147-2023-04652
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: 05414734006095
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: C00012474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2023
• 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
• Patient Age: 49 YR
• Patient Sex: Male