BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAART 200 AORTIC ANNULOPLASTY RING

    MDR report key: 21983846 · Received May 8, 2025

    Report

    Report Number
    3005687633-2025-00107
    Event Type
    Injury
    Date Received
    May 8, 2025
    Date of Event
    February 18, 2025
    Report Date
    June 20, 2025
    Manufacturer
    CORCYM INC.
    Product Code
    KRH
    UDI-DI
    10857160006147
    PMA / PMN Number
    K171431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: THE DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. FDA PREMARKET SUBMISSION NUMBER OF SIMILAR DEVICE: K171431 (SUPPLEMENT NUMBER 000); PRIMARY DI NUMBER FOR SIMILAR DEVICE: (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 ANY NEW INFORMATION OR AT THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    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. SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS, A FURTHER INVESTIGATION COULD NOT BE CONDUCTED. HOWEVER, A REVIEW OF THE MANUFACTURING RECORDS REVEALED NO DEFICIENCIES. BASED ON THE MANUFACTURER¿S EXPERIENCE AND THE MEDICAL JUDGMENT PROVIDED, IT IS REASONABLE TO CONCLUDE THAT THE REPORTED EVENT WAS LIKELY CAUSED BY INTERFERENCE BETWEEN THE LEAFLETS AND THE DEVICE, OCCURRING DURING THE DIASTOLIC PHASE. THIS INTERFERENCE MAY HAVE RESULTED FROM THE RING BEING POSITIONED TOO CLOSE TO THE NATIVE AORTIC VALVE LEAFLETS AND COULD HAVE BEEN FURTHER EXACERBATED BY SPECIFIC PATIENT CONDITIONS (E.G., HYPERTENSION), ALTHOUGH THIS CANNOT BE DEFINITIVELY CONFIRMED BASED ON THE AVAILABLE INFORMATION. IT IS IMPORTANT TO NOTE THAT THE DEVICE¿S INSTRUCTIONS FOR USE (IFU) RECOMMEND PLACING THE HAART DEVICE AT LEAST 2 MM BELOW THE LEAFLET-AORTIC JUNCTION AND THE TOPS OF THE SUBCOMMISSURAL TRIANGLES. THIS PRECAUTION, ACHIEVED THROUGH DEEP PLACEMENT OF THE IMPLANTATION SUTURES, IS INTENDED TO PREVENT CONTACT BETWEEN THE LEAFLETS AND THE DEVICE.

    Description of Event or Problem · 0

    ON FEBRUARY 19, 2025, THE MANUFACTURER WAS INFORMED OF A RECURRENCE OF AORTIC REGURGITATION IN A PATIENT IMPLANTED WITH A HAART 200 ANNULOPLASTY RING. BASED ON INITIAL INFORMATION RECEIVED, THE REGURGITATION WAS ATTRIBUTED TO A CLEFT CAUSED BY A TEAR IN THE CENTRAL PLICATION STITCHES. CONSEQUENTLY, THE MANUFACTURER ASSESSED THE EVENT AS UNRELATED TO THE DEVICE BUT RATHER TO THE SURGICAL PROCEDURE, DEEMING IT NOT REPORTABLE AS A SERIOUS INCIDENT. FURTHER INFORMATION RECEIVED ON MARCH 24, 2025, INDICATED THAT THE PATIENT HAD UNDERGONE REOPERATION WITH A GOOD OUTCOME. THE HAART DEVICE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHESIS. ON APRIL 8, 2025, THE MANUFACTURER RECEIVED IMAGES FROM THE EXPLANT PROCEDURE SHOWING THAT THE CLEFT WAS NOT SITUATED AT THE CENTRAL PLICATION STITCHES BUT AT THE BASE OF THE FUSED LEAFLETS, JUST ABOVE THE IMPLANTED RING. ACCORDING TO THE MEDICAL JUDGMENT RECEIVED, THIS COULD HAVE BEEN DUE TO INTERFERENCE BETWEEN THE LEAFLET AND THE IMPLANTED RING. THEREFORE, THE MANUFACTURER REASSESSED THE EVENT AS REPORTABLE AS SERIOUS INCIDENT.

    Description of Event or Problem · 0

    ON FEBRUARY 19, 2025, THE MANUFACTURER WAS INFORMED OF A RECURRENCE OF AORTIC REGURGITATION IN A PATIENT IMPLANTED WITH A HAART 200 ANNULOPLASTY RING. BASED ON INITIAL INFORMATION RECEIVED, THE REGURGITATION WAS ATTRIBUTED TO A CLEFT CAUSED BY A TEAR IN THE CENTRAL PLICATION STITCHES. CONSEQUENTLY, THE MANUFACTURER ASSESSED THE EVENT AS UNRELATED TO THE DEVICE BUT RATHER TO THE SURGICAL PROCEDURE, DEEMING IT NOT REPORTABLE AS A SERIOUS ADVERSE EVENT. FURTHER INFORMATION RECEIVED ON (B)(6) 2025, INDICATED THAT THE PATIENT HAD UNDERGONE REOPERATION WITH A GOOD OUTCOME. THE HAART DEVICE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHESIS. ON (B)(6) 2025, THE MANUFACTURER RECEIVED IMAGES FROM THE EXPLANT PROCEDURE SHOWING THAT THE CLEFT WAS NOT SITUATED AT THE CENTRAL PLICATION STITCHES BUT AT THE BASE OF THE FUSED LEAFLETS, JUST ABOVE THE IMPLANTED RING. ACCORDING TO THE MEDICAL JUDGMENT RECEIVED, THIS COULD HAVE BEEN DUE TO INTERFERENCE BETWEEN THE LEAFLET AND THE IMPLANTED RING OCCURRING DURING THE DIASTOLIC PHASE. THEREFORE, THE MANUFACTURER REASSESSED THE EVENT AS REPORTABLE UNDER SERIOUS INJURY. FURTHER INFORMATION RECEIVED INDICATED THAT, AT THE TIME OF HAART DEVICE IMPLANT, THE PATIENT WAS PRESENTING SEVERE AORTIC INSUFFICIENCY WITH PROLAPSE OF THE PARTIALLY FUSED CUPS, FRACTURE OF THE FREE EDGE OF THE CUSP, MODERATELY CALCIFIED LEAFLETS, ESPECIALLY AT THEIR EXTREMITIES, AND A VERY DILATED LEFT VENTRICLE. REPORTEDLY, PATIENT¿S NATIVE ANNULUS WAS MEASURED AT 24 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934624 HAART 200 AORTIC ANNULOPLASTY RING AORTIC ANNULOPLASTY RING KRH CORCYM INC. HAART 200-21 01-01074 10857160006147

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention