BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAART 200 AORTIC ANNULOPLASTY DEVICE

    MDR report key: 23713862 · Received December 4, 2025

    Report

    Report Number
    3005687633-2025-00139
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    September 2, 2025
    Report Date
    February 12, 2026
    Manufacturer
    CORCYM INC.
    Product Code
    KRH
    UDI-DI
    10857160006154
    PMA / PMN Number
    K171431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS A2, A3A, A4, B3, B4, B5, D4, D6B, E1, G3, G6, H2, H4, H6, H11. CORRECTED SECTIONS: D1 (BRAND NAME), G4 (PMA/510(K) NUMBER). THE MANUFACTURING AND MATERIAL RECORDS FOR THE DEVICE INVOLVED IN THIS EVENT, AS THEY PERTAIN TO THE REPORTED ISSUE, WERE RETRIEVED AND REVIEWED BY THE MANUFACTURER¿S QUALITY ENGINEERING. THE RESULTS CONFIRMED THAT THIS PROSTHESIS SATISFIED ALL REQUIRED MATERIAL, VISUAL, AND PERFORMANCE STANDARDS AT THE TIME OF MANUFACTURE AND RELEASE. IN CONCLUSION, SINCE THE HAART RING WAS ULTIMATELY REPLACED WITH AN INSPIRIS VALVE, IT IS REASONABLE TO CONCLUDE THE REPORTED EARLY EXPLANTATION OF THE DEVICE CAN BE ATTRIBUTED TO A FAILURE OF THE REPAIR PROCEDURE, RATHER THAN A MALFUNCTION OF THE DEVICE. FURTHERMORE, NO MANUFACTURING DEFICIENCIES WERE NOTED DURING THE REVIEW OF THE PRODUCTION RECORDS.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER IS CURRENTLY FOLLOWING-UP WITH THE INVOLVED HEALTHCARE FACILITY TO RETRIEVE FURTHER INFORMATION ON THE EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON AVAILABILITY OF ADDITIONAL DETAILS ON THE EVENT.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS NOTIFIED THE EARLY EXPLANTATION OF A HAART 200-23 AORTIC ANNULOPLASTY RING. THE FOLLOWING PROVIDES A COMPREHENSIVE SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER. THE DEVICE HAD BEEN IMPLANTED ON (B)(6) 2025 DURING AN ISOLATED AORTIC VALVE REPAIR PROCEDURE PERFORMED VIA FULL STERNOTOMY. THE PATIENT PRESENTED WITH A BICUSPID AORTIC VALVE (HIGHLY ASYMMETRIC L-R) AND UNDERWENT HAART 200 23 MM INTERNAL ANNULOPLASTY WITH FCC × 5 AND NCC × 1 PLICATIONS. NO POSITIONING DIFFICULTIES WERE REPORTED DURING THE INITIAL IMPLANTATION. IN THE POSTOPERATIVE PERIOD, THE PATIENT DEVELOPED SEVERE SYMPTOMATIC AORTIC REGURGITATION, WHICH WAS ATTRIBUTED TO A FAILURE OF THE REPAIR PROCEDURE. CONSEQUENTLY, THE HAART RING REQUIRED EARLY EXPLANTATION. THE REOPERATION TOOK PLACE ON (B)(6) 2025, DURING WHICH THE HAART 200-23 RING WAS REMOVED AND REPLACED WITH AN INSPIRIS RESILIA 25 PROSTHETIC VALVE. THE EXPLANTED RING AND ASSOCIATED AORTIC TISSUE WERE SUBMITTED FOR MICROBIOLOGICAL TESTING, AND NO MICROORGANISMS WERE CULTURED. THE PATIENT RECOVERED WELL FOLLOWING THE VALVE REPLACEMENT AND WAS DISCHARGED ON POSTOPERATIVE DAY 8, WITH SUBSEQUENT FOLLOW-UP SHOWING NO ADVERSE EVENTS OR COMPLICATIONS AFTER THE EXPLANTATION. NO ANONYMIZED DIAGNOSTIC IMAGING (ECHO, CT) HAS BEEN SHARED WITH THE MANUFACTURER.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS NOTIFIED THE EARLY EXPLANTATION OF A HAART 300 AORTIC ANNULOPLASTY RING. REPORTEDLY, THE RING WAS IMPLANTED ON (B)(6) 2025 AND EXPLANTED AROUND ONE MONTH LATER. DURING THE REOPERATION, FOLLOWING THE REMOVAL OF THE HAART RING, AN AORTIC VALVE REPLACEMENT WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2834678 HAART 200 AORTIC ANNULOPLASTY DEVICE AORTIC ANNULOPLASTY RING KRH CORCYM INC. 200-23 01-01113 10857160006154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention