BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAART 200 AORTIC ANNULOPLASTY RING

    MDR report key: 21997013 · Received May 9, 2025

    Report

    Report Number
    3005687633-2025-00112
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    January 8, 2025
    Report Date
    September 1, 2025
    Manufacturer
    CORCYM INC.
    Product Code
    KRH
    UDI-DI
    10857160006161
    PMA / PMN Number
    K171431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: B3, B4, B5, D4, D6A, D6B, G3, G6, H2, H4, H11. CORRECTED SECTIONS: G1. A COMPLETE MANUFACTURING AND MATERIAL RECORDS REVIEW FOR THE DEVICE OBJECT OF THE PRESENT DOCUMENT HAS BEEN PERFORMED. THE RESULTS CONFIRMED THAT THE DEVICE OBJECT OF THIS REVIEW SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE SPECIFICATIONS REQUIRED AT THE TIME OF MANUFACTURE AND RELEASE. SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THE MANUFACTURER COULD NOT PERFORM ANY FURTHER DIRECT INVESTIGATION ON THE INVOLVED HAART RING. BASED ON THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT. HOWEVER, IT IS REASONABLE TO ASSUME THAT THE EVENT LIKELY RESULTED FROM A COMBINATION OF CONTRIBUTING FACTORS. ACCORDING TO THE MANUFACTURER¿S EXPERIENCE, THE MOST RELEVANT FACTORS MAY INCLUDE UNEVEN SPACING OF THE SUTURES AND AN EXCESSIVELY HIGH POSITIONING OF THE RING, WHICH COULD HAVE LED TO CONTACT BETWEEN THE LEAFLETS AND THE DEVICE. ADDITIONALLY, THE POSSIBILITY THAT A LARGER RING SIZE, IF AVAILABLE, MIGHT HAVE BEEN MORE APPROPRIATE CANNOT BE EXCLUDED. PATIENT-SPECIFIC FACTORS (E.G. TISSUE FRAGILITY) MAY ALSO HAVE PLAYED A ROLE. IT IS IMPORTANT TO NOTE THAT THE INSTRUCTIONS FOR USE (IFU) FOR THE HAART DEVICE RECOMMEND THE FOLLOWING PRECAUTIONS: ¿ TO PREVENT SUTURES FROM PULLING THROUGH THE NATIVE ANNULAR TISSUE, PLEDGETS SHOULD BE USED AS DESCRIBED IN THE IFU. A SUFFICIENT NUMBER OF BROAD HORIZONTAL MATTRESS SUTURES SHOULD BE APPLIED TO ELIMINATE GAPS BETWEEN THE DEVICE AND THE ANNULAR TISSUE AND TO SUPPORT THE TENSION ASSOCIATED WITH ANNULAR REDUCTION. ¿ IMPLANTATION SUTURES SHOULD BE PLACED DEEPLY TO ENSURE THAT THE HAART DEVICE IS POSITIONED AT LEAST 2 MM BELOW THE LEAFLET-AORTIC JUNCTION AND THE TOPS OF THE SUBCOMMISSURAL TRIANGLES, IN ORDER TO PREVENT CONTACT BETWEEN THE LEAFLETS AND THE DEVICE. IT IS POSSIBLE THAT PATIENT-SPECIFIC ANATOMICAL CONDITIONS MAY HAVE PREVENTED OPTIMAL POSITIONING OF THE DEVICE, ALTHOUGH THIS CANNOT ULTIMATELY BE CONFIRMED BASED ON THE AVAILABLE INFORMATION.

    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 WAS SIMULTANEOUSLY INFORMED OF FOUR REOPERATIONS INVOLVING PATIENTS IMPLANTED WITH HAART 200 DEVICES OCCURRED AT MILITARY HOSPITAL BUDAPEST. THE INCIDENTS SHARE THE SAME EVENT DESCRIPTION AND MEDICAL JUDGMENT. THE MANUFACTURER IS SUBMITTING A REPORT FOR EACH OF THE NOTIFIED EVENTS AND IS FOLLOWING UP WITH THE HEALTHCARE FACILITY TO RETRIEVE ADDITIONAL INFORMATION ON EACH EVENT AD THE DEVICES INVOLVED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ANY NEW INFORMATION OR AT THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE MANUFACTURER HAS BEEN INFORMED OF A REOPERATION PERFORMED ON A PATIENT IMPLANTED WITH A HAART 200 DEVICE. ACCORDING TO THE NOTIFICATION RECEIVED, THE PATIENT UNDERWENT AORTIC VALVULOPLASTY ON (B)(6) 2024. PRE-OPERATIVE TRANSTHORACIC ECHOCARDIOGRAPHIC EXAMINATION SHOWED A BICUSPID AORTIC VALVE WITH AORTIC INSUFFICIENCY GRAD III/III, A WIDE CAVITY SIZE (EDD/ESD: 71/51 MM), NORMAL WALL THICKNESS, SYNCHRONOUS CONTRACTILITY, SLIGHTLY REDUCED LEFT VENTRICULAR SYSTOLIC FUNCTION, NORMAL-SIZED RIGHT VENTRICLE, MARKED MITRAL INSUFFICIENCY (MI) WITH CENTRAL JET, NOT VISIBLE SEGMENTAL WALL MOTION DISORDER. AFTER SIZING, A HAART 200 25MM AORTIC RING WAS IMPLANTED IN THE ANNULAR POSITION. THREE PLICATION SUTURES (6/0 KNOTTED PROLENE) WERE APPLIED TO THE FUSED CUSPS (LEFT AND RIGHT). AS REPORTED A GOOD COAPTATION WAS ACHIEVED AND NO AORTIC INSUFFICIENCY WAS DETECTED AT THE INTRA-OPERATIVE ECHO. AT THE EARLY POST-OPERATIVE TRANSTHORACIC ECHOCARDIOGRAPHY, A SLIGHT RESIDUAL PROLAPSE WAS NOTED ON THE RIGHT CORONARY LEAFLET SIDE AND RESIDUAL AORTIC INSUFFICIENCY (AI) OF AT MOST MILD DEGREE WAS VISIBLE OVERALL. A SYSTOLIC PEAK/AVERAGE GRADIENT OF 21/13HGMM WAS MEASURED, FROM THE SEPTUM, ON PARASTERNAL SHORT-AXIS SECTIONS WITH A DOUBLE JET (11H AND 13H) FROM ITS SURFACE, WITH A DOMINANT JET FROM THE RIGHT SIDE OUTSIDE OF THE RING. AT THE ECHOCARDIOGRAPHIC FOLLOW-UP PERFORMED ON (B)(6) 2024, THE RIGHT CORONARY LEAFLET WAS SHOWING A PROLAPTIFORM MOVEMENT, A SYSTOLIC PEAK/AVERAGE GRADIENT (VOLUME GRADIENT) OF 30/19 HGMM WAS MEASURED, MULTIPLE JETS WERE DETECTED MOSTLY FROM THE RIGHT CORONARY LEAFLET, BUT ALSO FROM THE NON-CORONARY LEAFLET, DEPENDING ON THE PROJECTION, WHICH WERE FILLING THE ENTIRE OUTFLOW TRACT OF THE LV, MOSTLY VALVULAR, PARTLY WITH PARARING ETIOLOGY. BASED ON THESE FINDINGS, THE PATIENT UNDERWENT RE-DO SURGERY WITH MINIMALLY INVASIVE APPROACH ON (B)(6) 2025. REPORTEDLY, THE HAART RING WAS FOUND WELL-SEATED IN THE ANNULUS EXCEPT AT THE FUSED COMMISSURE AND THE VALVULOPLASTY (PLICAL SUTURES WITH 6/0 PROLENE) WERE ALSO IN SITU. THE RIGHT CORONARY LEAFLET HAD COMPLETELY TORN OFF THE ANNULUS. THEREFORE, THE HAART RING WAS REMOVED AND AN AORTIC VALVE REPLACEMENT WAS PERFORMED WITH A MECHANICAL PROSTHESIS FROM A DIFFERENT MANUFACTURER (ON-X 27/29MM) WITHOUT REPORTED COMPLICATIONS. MEDICAL JUDGMENT SUGGESTS THAT THE PRIMARY CAUSE OF THE FAILURE IS LIKELY DUE TO THE INABILITY TO SECURE A STITCH IN THE FUSED COMMISSURE, AS INDICATED IN THE DEVICE'S IFU.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED OF A REOPERATION PERFORMED ON A PATIENT IMPLANTED WITH A HAART 200 DEVICE. ACCORDING TO THE NOTIFICATION RECEIVED, WITHIN A COUPLE OF WEEKS FOLLOWING THE IMPLANTATION OF THE AORTIC RING, THE PATIENT EXHIBITED INCREASED INSUFFICIENCY AND A DECLINE IN GRADIENT PERFORMANCE. DURING REOPERATION, A LEAFLET TEAR WAS OBSERVED AT THE LEVEL OF THE FUSED CUSPS. MEDICAL JUDGMENT SUGGESTS THAT THE PRIMARY CAUSE OF THE FAILURE IS LIKELY DUE TO THE INABILITY TO SECURE A STITCH IN THE FUSED COMMISSURE, AS INDICATED IN THE DEVICE'S IFU. THE MANUFACTURER IS FOLLOWING UP WITH THE HEALTHCARE FACILITY TO RETRIEVE ADDITIONAL DETAILS ON THE EVENT AND THE DEVICE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1909603 HAART 200 AORTIC ANNULOPLASTY RING AORTIC ANNULOPLASTY RING KRH CORCYM INC. HAART 200-25 01-01114 10857160006161

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention