BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® CLASSIC ANNULOPLASTY RING

    MDR report key: 4170637 · Received October 14, 2014

    Report

    Report Number
    2015691-2014-02410
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 15, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K912554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS AS IT WAS DISCARDED BY THE HOSPITAL. WITHOUT RETURN OF THE DEVICE, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. SURGEONS OFTEN ATTEMPT TO REPAIR VALVES IN LIEU OF REPLACING THEM DUE TO IMPROVED LONG-TERM CLINICAL OUTCOMES. THERE ARE TIMES WHEN A VALVE REPAIR IS ATTEMPTED USING AN ANNULOPLASTY RING AND SUBSEQUENT POST-REPAIR EVALUATION DEMONSTRATES AN INADEQUATE RESULT. THIS IS ALMOST UNIVERSALLY DUE TO SUBOPTIMAL ANATOMY, SURGICAL TECHNIQUE OR INAPPROPRIATE SIZING, AND NOT A MALFUNCTION OF THE ANNULOPLASTY RING. IN THIS CASE, THERE WAS NOT A MALFUNCTION, A MEDICAL DECISION WAS MADE TO REMOVE DEVICE AND REPAIR BY USING ANNULOPLASTY TECHNIQUES ONLY. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, EDWARDS HAS RECEIVED INFORMATION FROM THE IMPLANT PATIENT REGISTRY THAT A 26MM MITRAL RING WAS EXPLANTED AT IMPLANT DUE TO MODERATE REGURGITATION. IT WAS LEARNED THAT THE PATIENT WAS TAKEN OFF CARDIOPULMONARY BYPASS PRIOR TO THE EXPLANT. A COMMISSURE PLASTY WAS PERFORMED AND SHOWED SIGNIFICANT REDUCTION IN REGURGITATION AND CORRECTED PROLAPSE. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651574 CARPENTIER-EDWARDS® CLASSIC ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4400

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention