BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN MECHANICAL HEART VALVE

    MDR report key: 19367214 · Received May 21, 2024

    Report

    Report Number
    2135147-2024-02308
    Event Type
    Death
    Date Received
    May 21, 2024
    Date of Event
    January 28, 2012
    Report Date
    May 21, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. B2 - DATE OF DEATH IS ESTIMATED. THE ADDITIONAL PATIENT EFFECTS REPORTED IN THE ARTICLES ARE CAPTURED UNDER A SEPARATE MEDWATCH REPORT. SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF COMPARISON BETWEEN MINI-STERNOTOMY AND FULL STERNOTOMY FOR AORTIC VALVE REPLACEMENT: A 10-YEAR RETROSPECTIVE STUDY WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING ATRIAL FIBRILLATION, DIABETES, HYPERTENSION, MYOCARDIAL INFARCTION. SOME OF THE COMPLICATIONS REPORTED WERE DEATH, SURGICAL INTERVENTION (PACEMAKER, REDO-STERNOTOMY TO DRAIN EXCESS BLEEDING), HOSPITALIZATION, BLEEDING, STROKE, MYOCARDIAL INFARCTION, DEEP STERNAL WOUND INFECTION, CARDIAC TAMPONADE 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.

    Description of Event or Problem · 0

    THE ARTICLE, "COMPARISON BETWEEN MINI-STERNOTOMY AND FULL STERNOTOMY FOR AORTIC VALVE REPLACEMENT: A 10-YEAR RETROSPECTIVE STUDY", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY TO COMPARE THE CLINICAL OUTCOMES OF MINI-STERNOTOMY AND CONVENTIONAL STERNOTOMY. DEVICES INCLUDED IN THE STUDY WERE PERIMOUNT MAGNA EASE, ST. JUDE/ABBOTT MECHANICAL VALVE, AND CARBOMEDICS MECHANICAL VALVE. THE ARTICLE CONCLUDED THAT MINI-STERNOTOMY IS A SAFE OPTION FOR AVR. THE SAME NUMBER OF COMPLICATIONS WERE OBSERVED BETWEEN THE TWO GROUPS; HOWEVER, THERE WAS A REDUCTION IN THE DURATION OF HOSPITAL STAY AND INTENSIVE CARE UNIT (ICU) STAY AMONGST THE MINI-STERNOTOMY GROUP. [THE PRIMARY AND CORRESPONDING AUTHOR WAS AHMAD FARAZ, GENERAL SURGERY, ULSTER HOSPITAL, DUNDONALD, GBR, WITH CORRESPONDING EMAIL: [email protected]] THE TIME FRAME OF THE STUDY WAS FROM 28 JANUARY 2012 TO 27 NOVEMBER 2021. A TOTAL OF 371 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH IT WAS NOT CONFIRMED HOW MANY RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 59.14 YEARS FOR THE MINI-STERNOTOMY GROUP AND 62.34 YEARS FOR THE FULL STERNOTOMY GROUP. THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED ATRIAL FIBRILLATION, DIABETES, HYPERTENSION, MYOCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501961 UNKNOWN MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death