BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM TRIFECTA VALVE

    MDR report key: 19945405 · Received August 8, 2024

    Report

    Report Number
    2135147-2024-03873
    Event Type
    Death
    Date Received
    August 8, 2024
    Date of Event
    January 1, 2009
    Report Date
    August 8, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF TRIFECTA VALVE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING SMOKING, RENAL IMPAIRMENT, HYPERTENSION, DIABETES, LIVER DISEASE, CHRONIC LUNG DISEASE, PRIOR MYOCARDIAL INFARCTION, PRIOR HEART FAILURE, STROKE, ATRIAL FIBRILLATION, PRIOR CARDIAC SURGERY, PRIOR PERCUTANEOUS CORONARY INTERVENTION AND PRIOR TRANSCATHETER AORTIC VALVE INTERVENTION. SOME OF THE COMPLICATIONS REPORTED WERE PATIENT DEATH, SURGICAL INTERVENTION (PACEMAKER), UNEXPECTED MEDICAL INTERVENTION (BLOOD TRANSFUSION), BLEEDING, ATRIAL FIBRILLATION, STROKE AND RESPIRATORY FAILURE. 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: DEATH DATE IS ESTIMATED B3: DATE OF EVENT IS ESTIMATED D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: ARTICLE TITLE: AGE-SPECIFIC OUTCOMES OF BIOPROSTHETIC VS. MECHANICAL AORTIC VALVE REPLACEMENT: BALANCING REOPERATION RISK WITH ANTICOAGULATION BURDEN.

    Description of Event or Problem · 0

    THE ARTICLE, "AGE-SPECIFIC OUTCOMES OF BIOPROSTHETIC VS. MECHANICAL AORTIC VALVE REPLACEMENT: BALANCING REOPERATION RISK WITH ANTICOAGULATION BURDEN", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY THAT COMPARED THE OUTCOMES OF BIOPROSTHETIC VS. MECHANICAL AVR IN PATIENTS OLDER AND YOUNGER THAN 50. DEVICES INCLUDED IN THE STUDY WERE ST. JUDE MECHANICAL VALVE, MEDTRONIC ATS, LIVANOVA PLC CARBOMEDICS SORIN, CRYOLIFE ON-X, EDWARDS LIFESCIENCES MAGNA, ABBOTT TRIFECTA, LIVANOVA PERCEVAL, AND MEDTRONIC HANCOCK. THE ARTICLE CONCLUDED THAT OUTCOMES OF MECHANICAL AND BIOPROSTHETIC VALVE REPLACEMENT WERE COMPARABLE IN PATIENTS OLDER THAN 50 YEARS. USING BIOPROSTHETIC VALVES IN PATIENTS YOUNGER THAN 50 YEARS WAS ASSOCIATED WITH A GREATER RATE OF VALVE REINTERVENTION, WITH NO BENEFICIAL EFFECT ON THE RISK OF BLEEDING OR STROKE. [THE PRIMARY AND CORRESPONDING AUTHOR WAS AMR ARAFAT, ADULT CARDIAC SURGERY DEPARTMENT, PRINCE SULTAN CARDIAC CENTER, RIYADH 12233, SAUDI ARABIA, WITH CORRESPONDING EMAIL: [email protected]] THE TIME LINE OF THE STUDY WAS FROM 2009 TO 2020, WITH PHONE FOLLOW-UP IN JUNE 2021. A TOTAL OF 292 PATIENTS WERE INCLUDED IN THE STUDY, HOWEVER, THE NUMBER OF PATIENTS WHO RECEIVED AN ABBOTT DEVICE WAS NOT REPORTED. THE AVERAGE AGE FOR EACH GROUP WERE AS FOLLOWS: GROUP 1A = 64 YEARS; GROUP 2A = 58 YEARS; GROUP 1B = 38.5 YEARS; AND GROUP 2B = 31 YEARS. THE MAJORITY GENDER WAS MALE ACROSS ALL FOUR GROUPS. COMORBIDITIES INCLUDED SMOKING, RENAL IMPAIRMENT, HYPERTENSION, DIABETES, LIVER DISEASE, CHRONIC LUNG DISEASE, PRIOR MYOCARDIAL INFARCTION, PRIOR HEART FAILURE, STROKE, ATRIAL FIBRILLATION, PRIOR CARDIAC SURGERY, PRIOR PERCUTANEOUS CORONARY INTERVENTION, PRIOR TRANSCATHETER AORTIC VALVE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770958 SJM TRIFECTA VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death