BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO CHPV W RICKHAM UNITIZED

    MDR report key: 12917616 · Received December 2, 2021

    Report

    Report Number
    3013886523-2021-00526
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 8, 2021
    Report Date
    April 8, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10886704041481
    PMA / PMN Number
    K053107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H10. HAKIM VALVE (823113) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, A PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE MECHANISM. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM VALVE BECAME STUCK OVER TIME. IT IS UNKNOWN WHETHER THIS IS AN ISSUE CAUSED BY THE VALVE ITSELF, OR BY OTHER FACTORS. THE PATIENT MAY NEED REVISION SURGERY TO REPLACE THE VALVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815770 MICRO CHPV W RICKHAM UNITIZED CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 82-3113 10886704041481

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown