BEUDAMED
    FDA Adverse Event Death Summary report: N

    REGENT HEART VALVE

    MDR report key: 19316157 · Received May 14, 2024

    Report

    Report Number
    2135147-2024-02187
    Event Type
    Death
    Date Received
    May 14, 2024
    Date of Event
    January 1, 2003
    Report Date
    May 14, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF THE CLINICAL PERFORMANCE OF MECHANICAL AORTIC VALVE PROSTHESES. DEVICES INCLUDED ON-X, CARBOMEDICS, BICARBON, STANDARD REGENT, OPEN PIVOT, MASTERS, OR ADVANTAGE VALVE MODELS WERE REPORTED IN A RESEARCH ARTICLE "COMPARATIVE LONG-TERM CLINICAL PERFORMANCE OF MECHANICAL AORTIC VALVE PROSTHESES" IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING MYOCARDIAL INFARCTION, HEART FAILURE, ATRIAL FIBRILLATION, PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, PERCUTANEOUS CORONARY INTERVENTION, HYPERLIPIDEMIA, HYPERTENSION, ENDOCARDITIS, PERIPHERAL VASCULAR DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, DIABETES, STROKE, CANCER, HEPATIC DISEASE, ALCOHOL DEPENDENCE, CONCOMITANT CORONARY ARTERY BYPASS GRAFT. SOME OF THE COMPLICATIONS REPORTED WERE DEATH, SURGICAL INTERVENTION (VALVE EXPLANT/REINTERVENTION), HOSPITALIZATION, HEART FAILURE, BLEEDING, STROKE, TRANSIENT ISCHEMIC ATTACK, EMBOLISM; 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. B2: ESTIMATED DATE. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED LITERATURE ATTACHMENT: "COMPARATIVE LONG-TERM CLINICAL PERFORMANCE OF MECHANICAL AORTIC VALVE PROSTHESES".

    Description of Event or Problem · 0

    THE ARTICLE, "COMPARATIVE LONG-TERM CLINICAL PERFORMANCE OF MECHANICAL AORTIC VALVE PROSTHESES", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, MULTICENTER STUDY TO INVESTIGATE THE CLINICAL PERFORMANCE OF MECHANICAL AORTIC VALVE PROSTHESES. DEVICES INCLUDED ON-X, CARBOMEDICS, BICARBON, STANDARD REGENT, OPEN PIVOT, MASTERS, OR ADVANTAGE VALVE MODELS. THE ARTICLE CONCLUDED THAT IN THIS COHORT STUDY OF MECHANICAL VALVE SURGICAL AORTIC REPLACEMENT OUTCOMES IN SWEDEN, THE RATE OF ALL-CAUSE MORTALITY WAS HIGHER IN THE BICARBON GROUP THAN IN THE CARBOMEDICS, REGENT, AND STANDARD MODEL GROUPS. THESE FINDINGS WARRANT FURTHER RESEARCH ON THE LONG-TERM CLINICAL PERFORMANCE OF THE BICARBON VALVE. [THE PRIMARY AND CORRESPONDING AUTHOR WAS MICHAEL DISMORR,MD, PHD, DEPARTMENT OF MOLECULAR MEDICINE AND SURGERY, KAROLINSKA INSTITUTET, SE-171 76 STOCKHOLM, SWEDEN, WITH CORRESPONDING EMAIL: [email protected]] THE TIME FRAME OF THE STUDY WAS FROM 01 JANUARY 2003 TO 31 DECEMBER 2018. A TOTAL OF 5224 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 1394 (26.7%) RECEIVED AN ABBOTT DEVICE (REGENT - 567, MASTERS - 827). THE AVERAGE AGE WAS 56.8 YEARS AND THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED MYOCARDIAL INFARCTION, HEART FAILURE, ATRIAL FIBRILLATION, PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, PERCUTANEOUS CORONARY INTERVENTION, HYPERLIPIDEMIA, HYPERTENSION, ENDOCARDITIS, PERIPHERAL VASCULAR DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, DIABETES, STROKE, CANCER, HEPATIC DISEASE, ALCOHOL DEPENDENCE, CONCOMITANT CORONARY ARTERY BYPASS GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384141 REGENT HEART VALVE HEART-VALVE, MECHANICAL LWQ ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death