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

Catalog Number	19AGFN-756
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023 a 19mm sjm regent heart valve was implanted in a patient.During the procedure the valve lobe fell off when the valve was rotated.The two leaflets dislodged as one piece and was recovered from the patient.Therefore, the surgeon removed the sutures and replaced another 19mm sjm regent heart valve that successfully completed the procedure.The patient is stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant informationna.
Event or Problem Description
It was reported that on (b)(6) 2023 a 19mm sjm regent heart valve was implanted in a patient.During the procedure the valve lobe fell off when the valve was rotated.The two leaflets dislodged as one piece and was recovered from the patient.Therefore, the surgeon removed the sutures and replaced another 19mm sjm regent heart valve that successfully completed the procedure.The patient is stable.
Additional Manufacturer Narrative
The reported event of a dislodged leaflets was confirmed.Both leaflets were dislodged from the orifice and returned with the valve.One of the dislodged leaflets was found to be improperly inserted into the orifice in an upside-down position.No other damages or anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Two photographs from field appeared to show a mechanical valve having one leaflet dislodged from orifice while the other one was out of place within valve.The cause of the leaflet dislodgment could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Information from field indicated that the valve was in open position when rotated.Please note that per the instructions for use, "precautions: to avoid structural damage, the valve must be rotated in the fully closed position.".

• 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: 18121752
• Report Number: 2135147-2023-04982
• Device Sequence Number: 12483828
• Product Code: LWQ
• UDI-Device Identifier: 05414734005852
• UDI-Public: 05414734005852
• 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): 12/07/2023

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: 19AGFN-756
• Device Lot Number: C00006491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• 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