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

Catalog Number	21AGFN-756
Medical Device Problem Codes	Incomplete Coaptation (2507); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
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 21mm sjm regent heart valve with flex cuff was chosen for implant during an aortic valve replacement.Once the valve was placed, it was observed that one of the leaflets did not open completely due to interference from the myocardium.The holder handle was fully inserted into the orifice at a 90 degree angle.There was some resistance felt when rotating.The valve was in the semi-open position during rotation.On second attempt when the valve was rotated with the valve rotator, there was resistance again, and one of the leaflets dislodged as one piece.The piece was recovered from the patient.The valve was removed and replaced with a 19mm sjm regent heart valve with flex cuff.The patient remained hemodynamically stable throughout the procedure.There were no adverse patient effects reported.The patient status was reported as stable.
Additional Manufacturer Narrative
An event of one of the leaflets not opening completely due to interference from the myocardium and leaflet let dislodgement was reported.The investigation at abbott confirmed that one leaflet was dislodged from the orifice.The recessed pivot was received fractured and the butterfly recessed was chipped.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.One image from field appeared to show mechanical valve having one leaflet dislodged and placed on the side in a jar.While the root cause of the leaflet dislodgement could not be conclusively determined, there was no evidence of material defect in the carbon coating that may have caused or contributed to the dislodged leaflet.The damage noted to the valve may have been caused by some external force applied to the valve which overstressed the carbon material.It was reported that the valve was in the semi-open position during rotation and there was some resistance felt when rotating.Please note that per the instructions for use, "valve rotation: 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." and "caution: to avoid structural damage, the aortic 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: 18038612
• Report Number: 2135147-2023-04781
• Device Sequence Number: 7480856
• Product Code: LWQ
• UDI-Device Identifier: 05414734005975
• UDI-Public: 05414734005975
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

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: 21AGFN-756
• Device Lot Number: C00009502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• 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: 65 YR
• Patient Sex: Female