BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPEN PIVOT AP MITRAL HEART VALVE

    MDR report key: 12236267 · Received July 28, 2021

    Report

    Report Number
    3008592544-2021-00032
    Event Type
    Injury
    Date Received
    July 28, 2021
    Date of Event
    February 8, 2021
    Report Date
    July 27, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: PERZANOWSKA-BRZESZKIEWICZ K, ET AL. SEVERE DYSFUNCTION OF A MECHANICAL MITRAL VALVE PROSTHESIS COEXISTING WITH NON¿ST SEGMENT ELEVATION MYOCARDIAL INFARCTION. KARDIOL POL. 2021 MAR 25;79(3):352-353. DOI: 10.33963/KP.15800. EPUB 2021 FEB 8. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE CASE REPORT REGARDING A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD A ST. JUDE MECHANICAL MITRAL VALVE REPLACED BECAUSE OF THROMBOSIS WITH A 28 MM MEDTRONIC ATS MECHANICAL MITRAL VALVE. AT AN UNDISCLOSED TIME AFTER ATS VALVE IMPLANT, THE PATIENT PRESENTED TO THE AUTHORS FACILITY WITH ACUTE DYSPNEA AND ANGINA, HAVING BEEN REFERRED FROM A DIFFERENT FACILITY WITH SUSPICION OF NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI). LABORATORY TESTS REVEALED ELEVATED LEVELS OF CARDIAC BIOMARKERS. ELECTROCARDIOGRAM EXHIBITED ST-T WAVE CHANGES SUGGESTIVE OF NSTEMI; HOWEVER, THESE CHANGES WERE TRANSIENT. URGENT TRANSTHORACIC ECHOCARDIOGRAPHY REVEALED AN IMMOBILE MITRAL PROSTHETIC DISC, WITH INCREASED PEAK AND MEAN GRADIENTS OF 40 AND 31 MM HG, RESPECTIVELY. IN ADDITION, LEFT VENTRICULAR WALL MOTION ABNORMALITIES WERE NOTED. THREE DIMENSIONAL TRANSESOPHAGEAL ECHOCARDIOGRAPHY REVEALED SEVERE DYSFUNCTION OF THE ATS MITRAL VALVE. ONE OF THE VALVE¿S DISCS WAS IMMOBILE DUE TO A LARGE (>1 CM) MASS LOCATED ON THE VENTRICULAR SIDE. FLUOROSCOPY CONFIRMED OBSTRUCTION OF THE ATS MITRAL VALVE. INFUSION OF UNFRACTIONATED HEPARIN WAS STARTED. ON THE EIGHTH DAY AFTER ADMISSION, CARDIAC SURGERY WAS PERFORMED. DURING THE SURGERY, A THROMBUS AND PANNUS WERE FOUND ON BOTH SIDES OF THE ATS VALVE, THEN THE VALVE WAS EXPLANTED AND REPLACED WITH A 27 MM MEDTRONIC HANCOCK BIOPROSTHETIC VALVE. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139516 OPEN PIVOT AP MITRAL HEART VALVE HEART-VALVE, MECHANICAL LWQ MEDTRONIC, INC. 500DM

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R