BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MECHANICAL HEART VALVE

    MDR report key: 11877244 · Received May 25, 2021

    Report

    Report Number
    2648612-2021-00051
    Event Type
    Injury
    Date Received
    May 25, 2021
    Report Date
    July 7, 2021
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, A PATIENT WAS IMPLANTED WITH A 21MM SJM MECHANICAL HEART VALVE. AN EVENT OF DYSPNEA, CHEST PAIN, LEFT MAIN CORONARY ARTERY BIFURCATION EMBOLISM, ANTERIOR ST-ELEVATION MYOCARDIAL INFARCTION, FLASH ACUTE PULMONARY EDEMA, SINGLE LEAFLET MOTION, AND THROMBOSIS WAS REPORTED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    THE ARTICLE, "PROSTHETIC AORTIC VALVE THROMBOSIS COMPLICATED BY LEFT MAIN CORONARY ARTERY BIFURCATION EMBOLISM: CASE REPORT AND REVIEW OF LITERATURE", WAS REVIEWED. THIS RESEARCH ARTICLE IS A CASE STUDY OF A (B)(6)-YEAR-OLD FEMALE PATIENT WHO EXPERIENCED A NON-ST-ELEVATION MYOCARDIAL INFARCTION DUE TO LEFT MAIN CORONARY ARTERY BIFURCATION SUBOCCLUSION CAUSED BY MECHANICAL AORTIC VALVE LEAFLET THROMBOEMBOLISM. 8 YEARS-AGO THE PATIENT UNDERWENT MECHANICAL AORTIC VALVE(MAV) REPLACEMENT WITH A 21MM SJM MECHANICAL VALVE FOR SYMPTOMATIC BICUSPID AORTIC VALVE REGURGITATION. THE PATIENT RECENTLY PRESENTED TO THE HOSPITAL DUE TO SUDDEN ONSET OF DYSPNEA AND CHEST PAIN. A SIGNIFICANTLY ELEVATED HIGH-SENSITIVE TROPONIN SUGGESTED A NON-T-ELEVATION MYOCARDIAL INFARCTION(NSTEMI) AND THE PATIENT WAS TREATED WITH THERAPEUTICALLY DOSED LOW-MOLECULAR-WEIGHT HEPARIN. CORONARY ANGIOGRAM SHOWED A LEFT MAIN CORONARY ARTERY(LMCA) BIFURCATION EMBOLISM WITH SUBTOTAL OCCLUSION OF DISTAL LMCA EXTENDING TO BOTH OSTIAL LEFT ANTERIOR DESCENDING(LAD) AND OSTIAL LEFT CIRCUMFLEX CORONARY ARTERY (LCX). ADDITIONAL CINEFLUOROSCOPY REVEALED SINGLE MAV LEAFLET MOTION, SUSPICIOUS OF MAV THROMBOSIS, WHICH WAS SUBSEQUENTLY CONFIRMED BY URGENT TRANSESOPHAGEAL ECHOCARDIOGRAPHY(TEE). INTRAVENOUS THROMBOLYSIS AND UNFRACTIONATED HEPARIN INFUSION WERE STARTED. NO CORONARY INTERVENTION WAS PERFORMED AND THE PATIENT WAS TRANSFERRED TO THE CARDIAC INTENSIVE CARE UNIT FOR CLOSE MONITORING. 4 HOURS LATER THE PATIENT EXPERIENCED AN ANTERIOR ST-ELEVATION MYOCARDIAL INFARCTION ON ECG WITH FLASH ACUTE PULMONARY EDEMA REQUIRING INTUBATION. URGENT REPEAT CORONARY ANGIOGRAM SHOWED EMBOLIC DISTAL LAD OCCLUSION WITHOUT RESIDUAL LMCA CLOT. THE PATIENT WAS SWITCHED TO ORAL ANTICOAGULATION. DURING THREE MONTHS OF FOLLOW-UP MAV GRADIENTS NORMALIZED AND NO NEW THROMBOTIC OR BLEEDING COMPLICATIONS WERE NOTED. THE ARTICLE CONCLUDED ACUTE CORONARY SYNDROME(ACS) DUE TO CORONARY EMBOLISM(CE) IN THE SETTING OF PROSTHETIC VALVE THROMBOSIS(PVT) IS RARE AND THE DIFFERENTIAL DIAGNOSIS WITH ATHEROSCLEROTIC ACS IS CHALLENGING. THE PRIMARY AND CORRESPONDING AUTHOR OF THE ARTICLE IS FREDERIC DE ROECK, DEPARTMENT OF CARDIOLOGY, ANTWERP UNIVERSITY HOSPITAL (UZA), DRIE EIKENSTRAAT 655, B-2650 EDEGEM, BELGIUM WITH THE CORRESPONDING EMAIL: [email protected]. PATIENT'S INFORMATION (E.G. AGE, WEIGHT, GENDER, ETHNICITY, RACE, PATIENT'S INITIALS) CANNOT BE HANDLED BY ABBOTT IN ABSENCE OF PATIENT'S WRITTEN CONSENT AS REQUIRED BY THE PERSONAL DATA PROTECTION NATIONAL LEGISLATION. NATIONAL LEGISLATION PREVENTS THE RECORDING OF SUCH INFORMATION. A WRITTEN CONSENT HAS NOT BEEN OBTAINED IN THIS CASE; THEREFORE, THIS INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777226 SJM MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ ST. JUDE MEDICAL PUERTO RICO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention