BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MECHANICAL HEART VALVE

    MDR report key: 19634452 · Received June 28, 2024

    Report

    Report Number
    2135147-2024-03137
    Event Type
    Injury
    Date Received
    June 28, 2024
    Date of Event
    July 1, 2020
    Report Date
    June 28, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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: CLINICAL OUTCOMES OF PERCUTANEOUS TRANSCATHETER RELEASE OF STUCK MECHANICAL MITRAL VALVE WITH CEREBRAL EMBOLIC PROTECTION SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF CLINICAL OUTCOMES OF PERCUTANEOUS TRANSCATHETER RELEASE OF STUCK MECHANICAL MITRAL VALVE WITH CEREBRAL EMBOLIC PROTECTION WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING DIABETES, SYSTEMIC HYPERTENSION, SMOKING HISTORY, ATRIAL FIBRILLATION, CORONARY ARTERY DISEASE, PRIOR PERCUTANEOUS CORONARY INTERVENTION, PRIOR CORONARY ARTERY BYPASS GRAFT, PRIOR STROKE, PRIOR TRANSIENT ISCHEMIC ATTACK, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, AND CHRONIC KIDNEY DISEASE. SOME OF THE COMPLICATIONS REPORTED WERE UNEXPECTED MEDICAL INTERVENTION, HOSPITALIZATION, STROKE, STUCK LEAFLETS, REGURGITATION, THROMBUS, PANNUS 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, "CLINICAL OUTCOMES OF PERCUTANEOUS TRANSCATHETER RELEASE OF STUCK MECHANICAL MITRAL VALVE WITH CEREBRAL EMBOLIC PROTECTION", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY ON THE MID-TERM OUTCOME OF THE PERCUTANEOUS TRANSCATHETER RELEASE OF STUCK MECHANICAL VALVE (PETROS) WITH CEREBRAL EMBOLIC PROTECTION (CEP). MECHANICAL VALVES INCLUDED IN THIS STUDY WERE ATS-AP, CARBOMEDICS, ST. JUDE/ABBOTT, ON-X, MILTONIA, TTK CHITRA, OMNICARBON, AND MEDTRONIC HALL. THE ARTICLE CONCLUDED TRANSCATHETER RELEASE OF THE STUCK MITRAL MECHANICAL VALVE WITH CEREBRAL EMBOLIC PROTECTION IS AN ALTERNATIVE THERAPY WITH PROMISING MID-TERM OUTCOMES WHERE SURGERY OR FIBRINOLYSIS IS NOT POSSIBLE OR IN FAILED FIBRINOLYSIS SUBSETS. [THE PRIMARY AND CORRESPONDING AUTHOR WAS VASU NANDHAKUMAR, INSTITUTE OF CARDIO-VASCULAR DISEASES, THE MADRAS MEDICAL MISSION HOSPITAL, 4A, DR. J. JAYALALITHA NAGAR, MOGAPPAIR, CHENNAI, TAMIL NADU 600037, INDIA, WITH CORRESPONDING EMAIL [email protected]]. THE TIME FRAME OF THE STUDY WAS FROM JULY 2020 TO DECEMBER 2023. A TOTAL OF 24 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 3 (12.5%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 49.38 YEARS AND THERE WAS NO MAJORITY GENDER (# MALES = 12 OUT OF 24). THE AVERAGE WEIGHT WAS 62.54 KG. COMORBIDITIES INCLUDED DIABETES, SYSTEMIC HYPERTENSION, SMOKING HISTORY, ATRIAL FIBRILLATION, CORONARY ARTERY DISEASE, PRIOR PERCUTANEOUS CORONARY INTERVENTION, PRIOR CORONARY ARTERY BYPASS GRAFT, PRIOR STROKE, PRIOR TRANSIENT ISCHEMIC ATTACK, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, AND CHRONIC KIDNEY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821254 UNKNOWN MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| L| R| S