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

Model Number	19AGFN-756
Medical Device Problem Codes	Fracture (1260); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 19mm regent heart valve with flex cuff was selected for procedure.It was noted during procedure when attempting to rotate the valve, that a leaflet dislodgement occurred and an orifice fracture occurred.There was no resistance felt when rotating the valve and no instruments encounter the valve at the time of dislodgment/fracture.Nothing else other than the holder handle used to position or rotate the valve.The holder handle fully inserted into the orifice at a 90 degree angle.The valve was in a closed position when it was rotated and the leaflet dislodged/fractured.The leaflet was able to be retrieved, but it's noted that there are remains of the valve that remain in the heart.The physician did not try to reinsert the dislodged leaflet.The decision was made to remove and replace the 19mm regent heart valve with flex cuff with another one of the same size to complete the procedure.However, it was noted that halfway through implantation, the disc of the replacement valve ruptured.The disc completely detached when the sutures were tied.The patient was stable and fully recovered at the time of report.
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The event was reported by accident.There is no reported issue/malfunction with the device or patient effect due to the device.This event is being downgraded.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that pieces of the fractured 19mm regent heart valve with flex cuff orifice remained in the left ventricular outflow tract.The dislodged leaflet was able to be completely recovered from the patient.A correction needs to be made as there was actually no complication with the replacement 19mm regent heart valve with flex cuff.The replacement valve was implanted with no issues and remains implanted.The patient was not taken off bypass and placed back on bypass due to this event.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2648612; lot 20 b st caguas; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22159807
• Report Number: 2135147-2025-02988
• Device Sequence Number: 7292590
• Product Code: LWQ
• UDI-Device Identifier: 05415067042934
• UDI-Public: (01)05415067042934(17)290818
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/21/2025

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 Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: C00023195
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 06/15/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2024
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 84 KG