BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAART 300 AORTIC ANNULOPLASTY DEVICE

    MDR report key: 23320717 · Received October 17, 2025

    Report

    Report Number
    3005687633-2025-00131
    Event Type
    Injury
    Date Received
    October 17, 2025
    Report Date
    February 27, 2026
    Manufacturer
    CORCYM INC.
    Product Code
    KRH
    PMA / PMN Number
    K163608
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS B4, G3, G6, H2, H6, H11. SINCE THE LOT NUMBER OF THE DEVICE HAS NOT BEEN PROVIDED, NO DHR REVIEW COULD BE PERFORMED. IN CONCLUSION, THE HAART RING'S HOLDER SHOWS THREE SEGMENT, AND THE DEVICE'S IFU DETAIL HOW THE SEGMENTS SHOULD BE ORIENTED IN ORDER TO CORRECTLY IMPLANT THE DEVICE. THEREFORE, BASED ON THE INFORMATION AVAILABLE, IT IS REASONABLE TO CONCLUDE THAT THE EVENT WAS DUE TO A USER ERROR CAUSED BY A FAILURE TO FOLLOW THE INSTRUCTIONS.

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: D3, G1.

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: B2, B4, B5, D6A, G3, G6, H2, H6, H11. THE MANUFACTURER IS FURTHER FOLLOWING-UP WITH THE INVOLVED HEALTHCARE FACILITY, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON AVAILABILITY OF ANY ADDITIONAL INFORMATION ON THE EVENT.

    Additional Manufacturer Narrative · 0

    THE MISALIGNMENT REPORTEDLY OCCURRED BECAUSE THE ORIENTATION MARKERS ON THE HOLDER WERE NOT FOLLOWED, CONTRARY TO THE GUIDANCE PROVIDED IN THE HANDLING AND PREPARATION INSTRUCTIONS INCLUDED IN THE DEVICE¿S INSTRUCTIONS FOR USE (IFU). THE MANUFACTURER IS FURTHER FOLLOWING UP WITH THE HEALTHCARE FACILITY TO RETRIEVE ADDITIONAL DETAILS ON THE EVENT AND THE DEVICE INVOLVED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON AVAILABILITY OF ANY NEW INFORMATION.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS NOTIFIED OF AN EVENT RELATED TO A HAART 300 ANNULOPLASTY RING , OCCURRED DURING THE IMPLANTATION PROCEDURE ON (B)(6) 2025. REPORTEDLY, THE PATIENT DEVELOPED A HIGH PRESSURE GRADIENT FOLLOWING THE INITIAL PLACEMENT OF THE ANNULOPLASTY RING. ACCORDING TO MEDICAL JUDGMENT THIS WAS THE RESULT OF THE INCORRECT DEVICE ORIENTATION AT THE TIME OF IMPLANT, AS THE MARKERS ON THE HOLDER WERE NOT USED TO GUIDE THE DEVICE'S PLACEMENT. AS A RESULT, THE SURGEON HAD TO REMOVE THE RING AND REPOSITION IT PROPERLY. THE REPOSITIONING OF THE DEVICE WAS PERFORMED DURING THE SAME IMPLANTING PROCEDURE.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS NOTIFIED OF THE REOPERATION OF A PATIENT IMPLANTED WITH A HAART 300 ANNULOPLASTY RING. ACCORDING TO THE REPORT, THE PATIENT DEVELOPED A HIGH PRESSURE GRADIENT FOLLOWING THE INITIAL PLACEMENT OF THE ANNULOPLASTY RING. ACCORDING TO MEDICAL JUDGMENT THIS WAS THE RESULT OF THE INCORRECT DEVICE ORIENTATION AT THE TIME OF IMPLANT, AS THE MARKERS ON THE HOLDER WERE NOT USED TO GUIDE THE DEVICE'S PLACEMENT. AS A RESULT, THE SURGEON HAD TO PERFORM A REOPERATION A FEW DAYS LATER TO REPOSITION THE RING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541397 HAART 300 AORTIC ANNULOPLASTY DEVICE AORTIC ANNULOPLASTY RING KRH CORCYM INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R