BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC HALL PROSTHETIC HEART VALVE

    MDR report key: 13946004 · Received March 30, 2022

    Report

    Report Number
    2025587-2022-00838
    Event Type
    Injury
    Date Received
    March 30, 2022
    Date of Event
    March 24, 2020
    Report Date
    March 29, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWQ
    PMA / PMN Number
    P790018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MANTRI N.; ET AL. ¿OBSTRUCTION ALTERNANS¿: A RARE DOPPLER ECHOCARDIOGRAPHIC SIGN OF SEVERE, PROSTHETIC STENOSIS. J AM COLL CARDIOL. 2020 MAR, 75 (11_SUPPLEMENT_1) 3154. HTTPS://WWW.JACC.ORG/DOI/ABS/10.1016/S0735-1097(20)33781-5. PRESENTATION DATE: SUNDAY, MARCH 29, 2020. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: MED HALL EASY-FIT MECHANICAL MITRAL VALVE (PMA# P790018, PRODUCT CODE: LWQ) EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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 · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A (B)(6) YEAR-OLD FEMALE PATIENT WITH A HISTORY OF RHEUMATIC HEART DISEASE WHO UNDERWENT IMPLANT OF A 29-MM MEDTRONIC MED-HALL MECHANICAL MITRAL VALVE AND TRICUSPID VALVE ANNULOPLASTY RING AT AGE 29 YEARS (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). THE PATIENT WAS HOSPITALIZED WITH HEART FAILURE. A HEART AUSCULTATION PHONOCARDIOGRAM WAS ABNORMAL AND DOPPLER ECHOCARDIOGRAPHY INDICATED A CASE OF OBSTRUCTION ALTERNANS. THE PATIENT UNDERWENT SURGICAL VALVE REPLACEMENT USING A NON-MEDTRONIC MECHANICAL MITRAL VALVE PROSTHESIS. PATHOLOGICAL EXAMINATION OF THE EXPLANTED VALVE INDICATED CIRCUMFERENTIAL PANNUS FORMATION, WHICH WAS NOTED TO HAVE LED TO OBSTRUCTION OF LEAFLET MOTION, CAUSING SEVERE MITRAL STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2900415 MEDTRONIC HALL PROSTHETIC HEART VALVE HEART-VALVE, MECHANICAL LWQ MEDTRONIC HEART VALVES DIVISION M7700

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention| H UNKNOWN TRICUSPID ANNULOPLASTY RING