BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY RING

    MDR report key: 2072794 · Received April 29, 2011

    Report

    Report Number
    2015691-2011-15354
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K020864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT PROBLEM: (B)(4) - NO INFORMATION HAS BEEN RECEIVED. ADDITIONAL MANUFACTURER NARRATIVE: THE REASON FOR EXPLANT IS UNKNOWN. THE OPERATIVE REPORT AND PATIENT INFORMATION WAS REQUESTED, HOWEVER, NO INFORMATION HAS BEEN RECEIVED. DEVICE HISTORY RECORD REVIEW AND PRODUCT RETURN IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED, THE RING EXHIBIT MODERATE TO HEAVY HOST TISSUE OVERGROWTH. MINOR CUTS ARE DETECTED IN THE RING MOST LIKELY DUE TO EXPLANT. NO INCONSISTENCIES DETECTED IN THE X-RAY AS THE WIREFORM IS INTACT. METHOD: X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. HOST TISSUE/PANNUS GROWTH IS A COMPLEX PROCESS TRIGGERED BY THE INTERACTION BETWEEN THE HOST AND THE DEVICE AND IS HIGHLY VARIABLE AMONG PATIENTS. LITERATURE DEFINES PANNUS AS A TYPE OF SCARRING AND TISSUE INGROWTH. IT IS NOT CURRENTLY POSSIBLE TO PREDICT THE OCCURRENCE AND SEVERITY FOR ANY GIVEN PATIENT WITH A BIOPROSTHETIC HEART VALVE. A CERTAIN DEGREE OF HOST TISSUE GROWTH IS EXPECTED. HOWEVER, ABNORMAL OR SEVERE PANNUS GROWTH CAN EVENTUALLY AFFECT THE FUNCTION OF THE VALVE. ACCORDING TO LITERATURE, PANNUS TYPICALLY OCCURS BETWEEN 12 MONTHS TO 5 YEARS. SINCE THE MECHANISM OF HOST TISSUE GROWTH IN BIOPROSTHETIC HEART VALVES IS STILL NOT FULLY UNDERSTOOD, THE ROOT CAUSE FOR THE HOST TISSUE GROWTH FOR THIS PARTICULAR VALVE CANNOT BE DETERMINED AT THIS TIME. OVERALL, BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY DURING THE MANUFACTURE OF THE DEVICE THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EDWARDS TRICUSPID RING AND MITRAL VALVE (B)(4) WERE EXPLANTED DUE TO UNKNOWN REASON AFTER AN IMPLANT DURATION OF APPROXIMATELY 85 MONTHS.

    Description of Event or Problem · 1

    THE OPERATIVE REPORT STATES THAT PATIENT HAS SEVERE RECURRENT TRICUSPID REGURGITATION. "THE TRICUSPID VALVE ANNULUS WAS DILATED. THE SUTURES OF THE ORIGINAL TRICUSPID VALVE REPAIR, IN VIEW OF THE SEVERE DILATATION OF THE RIGHT VENTRICLE, DID SLIDE. THE LEAFLETS OF THE [NATIVE] VALVE WERE SEVERELY STRETCHED AND REDUNDANT, AS WELL AS SOMEWHAT PROLAPSING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4900 3H1556

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R