BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAART 200 AORTIC ANNULOPLASTY RING

    MDR report key: 21996909 · Received May 9, 2025

    Report

    Report Number
    3005687633-2025-00109
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    August 23, 2024
    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, H6, 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 INFORMATION PROVIDED TO THE MANUFACTURER, THE PATIENT INVOLVED WAS DIAGNOSED WITH ENDOCARDITIS AFFECTING BOTH THE AORTIC AND MITRAL VALVES AT THE TIME OF REOPERATION, WHICH OCCURRED APPROXIMATELY FIVE MONTHS AFTER THE INITIAL SURGERY. ACCORDING TO SCIENTIFIC LITERATURE, INFECTIONS OCCURRING BETWEEN TWO AND TWELVE MONTHS POST-SURGERY ARE TYPICALLY ASSOCIATED WITH LATE-ONSET NOSOCOMIAL INFECTIONS OR COMMUNITY-ACQUIRED INFECTIONS. AS PART OF THE INVESTIGATION, A REVIEW OF THE MANUFACTURING AND MATERIAL RECORDS FOR THE HAART 200 AORTIC ANNULOPLASTY DEVICE INVOLVED IN THE REPORTED EVENT DID NOT REVEAL ANY DEFICIENCIES THAT WOULD SUGGEST A LINK BETWEEN THE DEVICE¿S QUALITY AND THE ONSET OF ENDOCARDITIS. ALTHOUGH IT IS NOT POSSIBLE TO EXCLUDE THE CONTRIBUTION OF OTHER FACTORS¿SUCH AS SUBOPTIMAL DEVICE POSITIONING¿THE MANUFACTURER¿S EXPERIENCE SUPPORTS THE CONCLUSION THAT THE ROOT CAUSE IS MOST LIKELY ATTRIBUTABLE TO ENDOCARDITIS. THIS CONDITION MAY HAVE SIGNIFICANTLY ALTERED TISSUE PHYSIOLOGY, LEADING TO WEAKENING OF THE AFFECTED AREAS. IT IS IMPORTANT TO NOTE THAT ENDOCARDITIS IS LISTED AMONG THE POTENTIAL COMPLICATIONS IN THE DEVICE¿S INSTRUCTIONS FOR USE (IFU). THEREFORE, THE EVENT CAN BE CONSIDERED AN INHERENT RISK ASSOCIATED WITH THE USE OF THE DEVICE.

    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 (B)(6). 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 AT THE RECEIPT OF ANY NEW INFORMATION OR AT THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS INFORMED OF A REOPERATION PERFORMED ON A PATIENT IMPLANTED WITH HAART 200 DEVICE. ACCORDING TO THE NOTIFICATION RECEIVED, THE PATIENT UNDERWENT AORTIC VALVULOPLASTY ON (B)(6) 2024 THROUGH PARTIAL STERNOTOMY. PRE-OPERATIVE TRANSTHORACIC ECHOCARDIOGRAPHIC (TTE) EXAMINATION SHOWED A BICUSPID AORTIC VALVE WITH RAPHE VISIBLE BETWEEN THE LEFT AND RIGHT LEAFLETS, GRADE III AORTIC INSUFFICIENCY, A LEFT VENTRICLE WITH NORMAL DIMENSIONS, CONCENTRICALLY HYPERTROPHIC WALL THICKNESS, SYNCHRONOUS CONTRACTION, PRESERVED SYSTOLIC FUNCTION, RIGHT VENTRICLE WITH NORMAL DIMENSIONS, A STRUCTURALLY INTACT MITRAL VALVE WITH REVERSE DOMING VISIBLE ON THE ANTERIOR LEAFLET, NO SEGMENTAL WALL MOTION DISORDER. AFTER SIZING, A 25MM HAART RING WAS IMPLANTED SUBANNULARLY WITH TEFLON STITCHES (TWISTED). PLICATION SUTURES WERE PLACED ON BOTH THE FUSED LEAFLETS (4 KNOTTED) AND THE NON-CORONARY LEAFLET (2 KNOTTED MONOFILAMENT) TO CREATE A SUFFICIENTLY HIGH COAPTATION SURFACE. INTRAOPERATIVE TEE SHOWED PERFECT VALVE CLOSURE, WITHOUT AORTIC VALVE STENOSIS AND ELEVATED GRADIENTS. THE EARLY POST-OPERATIVE TRANSTHORACIC ECHOCARDIOGRAPHY CONFIRMED THAT THE AORTIC INSUFFICIENCY WAS SUCCESSFULLY CORRECTED, A PEAK/AVERAGE SYSTOLIC GRADIENT OF 39/20 MMHG AND AOV MAX. 3.1 M/S WERE MEASURED. EOA CALCULATED BASED ON THE CONTINUITY EQUATION WAS 1.30 CM2. AT AN ECHOCARDIOGRAPHIC FOLLOW-UP PERFORMED ON (B)(6) 2024, GRADE III/III AORTIC INSUFFICIENCY WAS DETECTED, A JET (GR II) FROM THE AORTIC OUTFLOW TRACT INTO THE LEFT ATRIUM WAS IDENTIFIED. IN ADDITION, ECHODENSE MOBILE DEPOSITION WAS VISIBLE ON THE VALVE TOWARDS THE LEFT VENTRICULAR OUTFLOW TRACT. BASED ON THESE FINDINGS, THE PATIENT UNDERWENT RE-DO SURGERY ON (B)(6) 2024. REPORTEDLY, A HUGE PERFORATION ALONG THE FUSED AND PREVIOUSLY STICHED RIGHT AND LEFT LEAFLETS ALONG THE PLANE OF THE ANNULUS WAS VISIBLE, WHICH CAUSED THE INSUFFICIENCY. NO VEGETATIONS WERE SEEN ON THE TISSUE OF THE VALVE. THE HAART DEVICE WAS REMOVED AND A BIOPROSTHESIS FROM A DIFFERENT MANUFACTURER WAS IMPLANTED (EDWARDS LIFESCIENCES, INSPIRIS RESILIA SIZE 29) WITH NO REPORTED COMPLICATIONS. IN ADDITION, THE FENESTRATION DETECTED BY ECHO ON THE MITRAL LEAFLET WAS CLOSED WITH A FIGURE 8 SUTURE. MEDICAL JUDGMENT SUGGESTS THAT THE PRIMARY CAUSE OF THE AORTIC VALVULOPLASTY 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
    1748817 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