BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MECHANICAL HEART VALVE

    MDR report key: 19838466 · Received July 26, 2024

    Report

    Report Number
    2135147-2024-03620
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    January 1, 1989
    Report Date
    May 8, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT IS ESTIMATED. D4 - THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED LITERATURE ATTACHMENT: MECHANICAL OR BIOLOGICAL PROSTHESIS FOR AORTIC VALVE REPLACEMENT IN PATIENTS AGED 45 TO 74 YEARS. SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF THE LONG-TERM OUTCOMES OF PATIENTS UNDERGOING AORTIC VALVE REPLACEMENT WITH BIOLOGICAL OR MECHANICAL AORTIC VALVE PROSTHESES WERE REPORTED IN A RESEARCH ARTICLE "MECHANICAL OR BIOLOGICAL PROSTHESIS FOR AORTIC VALVE REPLACEMENT IN PATIENTS AGED 45 TO 74 YEARS", IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HYPERTENSION, DIABETES, ATRIAL FIBRILLATION, CHRONIC KIDNEY DISEASE, HEART FAILURE, PERIPHERAL VASCULAR DISEASE, PRIOR STROKE, CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, CORONARY ARTERY BYPASS GRAFT. SOME OF THE COMPLICATIONS REPORTED WERE SURGICAL OPERATION (REDO), HOSPITALIZATION, STROKE, BLEEDING THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 0

    CORRECTION: B3 EVENT DATE CORRECTED. B3 - DATE OF EVENT IS ESTIMATED. D4 - THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. LITERATURE ATTACHMENT: MECHANICAL OR BIOLOGICAL PROSTHESIS FOR AORTIC VALVE REPLACEMENT IN PATIENTS AGED 45 TO 74 YEARS.

    Description of Event or Problem · 0

    THE ARTICLE, "MECHANICAL OR BIOLOGICAL PROSTHESIS FOR AORTIC VALVE REPLACEMENT IN PATIENTS AGED 45 TO 74 YEARS", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, MULTICENTER STUDY COMPARING THE LONG-TERM OUTCOMES OF PATIENTS UNDERGOING AORTIC VALVE REPLACEMENT WITH BIOLOGICAL OR MECHANICAL AORTIC VALVE PROSTHESES. DEVICES INCLUDED IN THE STUDY WERE PERIMOUNT, TRIFECTA, MAGNA, MITROFLOW, CARPENTIER-EDWARDS, HANCOCK, MOSAIC, EPIC, BIOCOR, PERCEVAL, EDWARDS-INSPIRIS, INTACT, INTUITY, ST. JUDE MECHANICAL VALVE, CARBOMEDICS, ON-X, MEDTRONIC HALL, STARR-EDWARDS, BAXTER-MIRA, AND ATS. THE ARTICLE CONCLUDED THE ARTICLE CONCLUDED THAT COMPARED TO BIOPROSTHESES, MECHANICAL AORTIC VALVES ARE ASSOCIATED WITH A LOWER ADJUSTED RISK OF LONG-TERM MORTALITY IN PATIENTS AGED 70 YEARS OR YOUNGER. PATIENTS <70 YEARS OLD UNDERGOING SURGICAL AORTIC VALVE REPLACEMENT (SAVR) SHOULD BE INFORMED OF THE POTENTIAL SURVIVAL BENEFIT OF MECHANICAL VALVE SUBSTITUTES. [THE PRIMARY AND CORRESPONDING AUTHOR IS HARTZELL SCHAFF, DEPARTMENT OF CARDIOVASCULAR SURGERY, MAYO CLINIC, ROCHESTER, MN, WITH CORRESPONDING EMAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS FROM JANUARY 1989 TO DECEMBER 2019. A TOTAL OF 5762 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 1920 (33.3%) RECEIVED AN ABBOTT DEVICE (TRIFECTA, N=625; EPIC/BIOCOR, N=294; AND SJM MHV, N=1001). THE AVERAGE AGE WAS 65 YEARS AND THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED HYPERTENSION, DIABETES, ATRIAL FIBRILLATION, CHRONIC KIDNEY DISEASE, HEART FAILURE, PERIPHERAL VASCULAR DISEASE, PRIOR STROKE, CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, CORONARY ARTERY BYPASS GRAFT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946461 UNKNOWN MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ ABBOTT MEDICAL UNK MECHANICAL HEART VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R| S| H