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

Catalog Number	19AGFN-756
Medical Device Problem Codes	Fracture (1260); Incomplete Coaptation (2507); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
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) 2024, a 19mm regent aortic mechanical heart valve was chosen for implantation.Before implantation, a resection was performed which completely decalcified the leaflet.Using the sizing ring, the annulus was measured to be 19mm.When the suture was passed through the sewing cuff and knotted, it was noticed that the ring was fractured and a disc was stuck.The valve was removed.There had been resistance while rotating.Holder handle was fully inserted into the orifice at a 90 degree angle.All pieces of the fractured ring were removed from the anatomy.The physician decided to enlarge the aortic ring via the yang technique and implant a replacement 23mm regent aortic valve.There were no adverse patient consequences or clinically significant delay.The patient remained hemodynamically stable throughout the procedure.The patient remained on cardiopulmonary bypass throughout the procedure without intervention.There was a reported delay that resulted in no patient consequences.
Event or Problem Description
It was reported that on (b)(6) 2024, a 19mm regent aortic mechanical heart valve was chosen for implantation.Before implantation, a resection was performed which completely decalcified the leaflet.Using the sizing ring, the annulus was measured to be 19mm.When the suture was passed through the sewing cuff and knotted, it was noticed that the ring was fractured and a disc was stuck.The valve was removed.There had been resistance while rotating.Holder handle was fully inserted into the orifice at a 90 degree angle.All pieces of the fractured ring were removed from the anatomy.The physician decided to enlarge the aortic ring via the yang technique and implant a replacement 23mm regent aortic valve.There were no adverse patient consequences or clinically significant delay.The patient remained hemodynamically stable throughout the procedure.The patient remained on cardiopulmonary bypass throughout the procedure without intervention.There was a reported delay that resulted in no patient consequences.
Additional Manufacturer Narrative
An event of the orifice being fractured and the disk being stuck was reported.The investigation found that the orifice was fractured near the one pivot guard of the valve.The piece of the orifice that had fractured was returned and was of an irregular shape.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.While the root cause of the leaflet dislodgement could not be conclusively determined, there was no evidence of the material defect in the carbon coating that may have caused or contributed to the damaged orifice.The damage may have been caused by some external force applied to the valve which overstressed the carbon material.Please note per the instructions for use, " 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.".

• 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: 18915823
• Report Number: 2135147-2024-01152
• Device Sequence Number: 17835008
• Product Code: LWQ
• UDI-Device Identifier: 05414734005852
• UDI-Public: (01)05414734005852(17)280506(10)C00011803
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

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: 19AGFN-756
• Device Lot Number: C00011803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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: 64 YR
• Patient Sex: Female