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

Catalog Number	19AGFN-756
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Liver Damage/Dysfunction (1954)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023, a 19mm sjm regent heart valve was implant in a patient.Perioperatively, anticoagulant drug lovenox was given to the 49-year-old patient.Treatment was interrupted for 48 hours following hepatic cytolysis.Ultrasound checks were carried out for 7 days postoperatively and showed nothing and patient patient continue to have anticoagulant.The patient have any hematologic disorders or systemic illness that could contribute to a hypercoagulability.On (b)(6) 2023, it was reported that thrombosis was detected on the valve following an ultrasound check.Evidence of dysfunction of the mechanical valve with an average gradient of 67 mmhg and iao 2/4 whereas the previous ultrasounds were unremarkable on the valvular level.Transesophageal echocardiography (tee) and cine-angiography showed one wing to be immobile and another blocked in an intermediate position.The device was explanted and a non-abbott device was implanted.The patient is stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of thrombus on the valve was confirmed.The investigation found that there was adherent calcified thrombus on the inflow and outflow surface of the mechanical heart valve leaflets and in the pivot recesses.The leaflets were immobile.There was an adherent clot on the sewing cuff.No inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that the patient was prescribed an anticoagulant and was compliant, with no disorders or medication which could have contributed to hypercoagulability.Treatment was interrupted for 48 hours following hepatic cytolysis.Their inr at the time of the event was normal due to the progressive dose introduction of avk treatment for 4 days with coumadin.The thrombus noted on the valve could have contributed to the immobility of the valve leaflets.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 17927521
• Report Number: 2135147-2023-04491
• Device Sequence Number: 6311863
• Product Code: LWQ
• UDI-Device Identifier: 05414734005852
• UDI-Public: 05414734005852
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: 31210388
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female