BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPEN PIVOT STANDARD AORTIC HEART VALVE

    MDR report key: 7010888 · Received November 8, 2017

    Report

    Report Number
    3008592544-2017-00061
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    December 1, 2016
    Report Date
    November 8, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ALAWAMI, M. MD ET AL. PARAVALVULAR LEAK AFTER MECHANICAL AORTIC VALVE REPLACEMENT CAUSING HEMOLYTIC ANEMIA: CLOSURE WITH VASCULAR PLUG. JOURNAL OF CARDIOVASCULAR MEDICINE (2016) 2016 DEC;17 SUPPL 2:E189-E190 DOI 10.2459/JCM.0000000000000132 EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A (B)(6) MALE PATIENT WHO WAS IMPLANTED WITH A MEDTRONIC 23MM ATS OPEN PIVOT MECHANICAL VALVE (SERIAL NUMBER NOT PROVIDED). TWO MONTHS POST IMPLANT, THE PATIENT COMPLAINED OF DYSPNEA AND LETHARGY. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TOE) AT THREE MONTHS, INDICATED MODERATE PARAVALVULAR LEAK (PVL) WITH NORMAL AORTIC VALVE FUNCTION. SUBSEQUENTLY, A PERCUTANEOUS CLOSURE WAS PERFORMED WITH A VASCULAR PLUG WHICH REDUCED THE PVL TO TRACE. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789596 OPEN PIVOT STANDARD AORTIC HEART VALVE HEART-VALVE, MECHANICAL LWQ MEDTRONIC, INC. 500FA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention