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); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a 19mm sjm regent heart valve w/ flex cuff was chosen for a procedure.During procedure, after placement, attempted rotation was difficult, and when a bit of force was applied to rotate, the pivot guard was fractured.The valve was explanted and a new 19mm non-abbott valve was used instead.There was an extension of the procedure time, but it did not affect the patient's prognosis.The patient¿s current status was reported stable.
Additional Manufacturer Narrative
An event of difficulty rotating the valve and fracture in the pivot guard was reported.Information from the field indicated that pivot guard fractured when a bit of force was applied to rotate the valve.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the reported damage is consistent with applying external force to rotate the valve.The reported difficulty rotating the valve could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that per the instructions for use, using the valve holder/rotator and the flexible valve holder handle model 905-hh, or the rigid valve holder handle model 905-rhh, rotate the valve in situ to the desired position.The valve should rotate freely.If resistance is noted, the valve holder/rotator may not be properly seated in the valve, the valve may not be in the fully closed position, or the valve may be oversized.If the valve does not rotate freely, do not force valve rotation.
Event or Problem Description
N/a.

• 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): ABBOTT MEDICAL REG# 2648612; lot 20 b st caguas; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22145134
• Report Number: 2135147-2025-02946
• Device Sequence Number: 7390351
• Product Code: LWQ
• UDI-Device Identifier: 05415067042934
• UDI-Public: (01)05415067042934(17)261102
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/10/2025

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: 8207023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2021
• 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: 62 YR
• Patient Sex: Unknown
• Patient Weight: 52 KG