BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAART AORTIC ANNULOPLASTY DEVICE

    MDR report key: 19565458 · Received June 19, 2024

    Report

    Report Number
    3005687633-2024-00110
    Event Type
    Injury
    Date Received
    June 19, 2024
    Report Date
    August 19, 2024
    Manufacturer
    BIOSTABLE
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE SEVERAL GOOD FAITH ATTEMPTS TO FOLLOW UP WITH THE IMPLANTING SITE, THE MANUFACTURER DIDN'T RECEIVE ANY FURTHER INFORMATION ON THE EVENT AND THE DEVICE INVOLVED NOR CONFIRMATION THAT THE VALVE IN RING PROCEDURE WAS ULTIMATELY PERFORMED. IN PARTICULAR, THE MANUFACTURER DIDN'T RECEIVE ANY INFORMATION REGARDING THE PATIENT'S INDICATION TO AORTIC VALVE REPAIR, PATIENT'S CLINICAL HISTORY AND RISK FACTORS, DETAILS ON THE SURGERY AND POSSIBLE CONCOMITANT PROCEDURES PERFORMED, CLINICAL AND INSTRUMENTAL ASSESSMENT OF THE FAILED IMPLANT AS WELL AS THE PERFORMANCE OF THE IMPLANT OVER TIME. THE TIME FROM IMPLANTATION TO FAILURE DETECTION IS ALSO UNKNOWN. SINCE THE MODEL AND LOT NUMBER OF THE DEVICE REMAIN UNKNOWN TO THE MANUFACTURER, NO REVIEW OF THE PRODUCTION RECORDS COULD BE PERFORMED. IN ADDITION, BEING THE DEVICE NOT ACCESSIBLE FOR TESTING, NO DIRECT INVESTIGATION COULD BE CONDUCTED ON THE INVOLVED RING. DUE TO THE LACK OF INFORMATION, THE MANUFACTURER IS NOT ABLE TO DRAW ANY CONCLUSION REGARDING THE REPORTED EVENT AND THE DEVICE INVOLVED. AS SUCH, THE POSSIBLE ROOT CAUSE OF THE EVENT CANNOT BE ESTABLISHED. IT SHOULD BE NOTED THOUGH THAT, SIMILARLY TO MITRAL VALVE REPAIR USING MITRAL ANNULOPLASTY DEVICES, IT IS NOT ALWAYS POSSIBLE TO DETERMINE AN EXACT CAUSE OF REPAIR FAILURE OR ANY ASSOCIATION OF THE ANNULOPLASTY DEVICE TO THE FAILURE. THIS IS ESPECIALLY TRUE IF A TAVR-IN-HAART PROCEDURE IS PERFORMED BECAUSE THIS PERCUTANEOUS APPROACH DOESN¿T ALLOW FOR DIRECT VISUALIZATION OF THE HAART DEVICE OR THE AORTIC VALVE LEAFLETS. THE MANUFACTURER WILL SUBMIT AN ADDITIONAL FOLLOW UP REPORT UPON RECEIPT OF ANY POSSIBLE ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    NOTE: MANUFACTURER ON LABEL IS BIOSTABLE, NOW ACQUIRED BY CORCYM INC. WITH REGISTERED ADDRESS AT (B)(4). THE MANUFACTURER IS FOLLOWING UP WITH THE HEALTHCARE FACILITY TO RETRIEVE ADDITIONAL INFORMATION ON THE EVENT AND THE DEVICE INVOLVED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF FURTHER INFORMATION.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED THAT A PATIENT IMPLANTED WITH A HAART 19MM RING IS UNDER EVALUATION FOR A TAVR PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579206 HAART AORTIC ANNULOPLASTY DEVICE AORTIC ANNULOPLASTY RING KRH BIOSTABLE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention| O