BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPEN PIVOT MECHANICAL HEART VALVE

    MDR report key: 14274093 · Received May 4, 2022

    Report

    Report Number
    3008592544-2022-00018
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    April 19, 2022
    Report Date
    May 2, 2022
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 29MM MITRAL MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH AN U UNSPECIFIED SIZED MEDTRONIC DEVICE. THE REASON FOR THE REPLACEMENT WAS REPORTED TO BE DUE TO A LEAFLET DETACHING DURING VALVE ANNULUS SUTURING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501094 OPEN PIVOT MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ MEDTRONIC, INC. 500DM29

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention