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

Catalog Number	23AGFN-756
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 23mm sjm regent mechanical heart valve with flex cuff was selected for implant.During the procedure, the holder handle fully inserted into the orifice at a 90 degree angle.It was noted after implanting the valve, that one of the leaflets was unable to close/coapt properly.Device was replaced with another 23mm sjm regent mechanical heart valve with flex cuff.The patient remained stable throughout the procedure.There was no clinical significant delay as the result of this event.
Additional Manufacturer Narrative
An event of one of the leaflets of a valve being unable to close/co-apt properly was reported.The device was returned to abbott for analysis and the investigation found that both leaflets were intact and undamaged and that the valve rotated freely.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The root 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.
Event or Problem Description
It was reported that (b)(6) 2023, a 23mm sjm regent mechanical heart valve with flex cuff was selected for implant.During the procedure, the holder handle fully inserted into the orifice at a 90 degree angle.It was noted after implanting the valve, that one of the leaflets was unable to close/coapt properly.Device was replaced with another 23mm sjm regent mechanical heart valve with flex cuff.The patient remained stable throughout the procedure.There was no clinical significant delay as the result of this event.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17475007
• Report Number: 2135147-2023-03464
• Device Sequence Number: 15307508
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: 05414734006095
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: 8301131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown