BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    MDR report key: 2030016 · Received March 25, 2011

    Report

    Report Number
    2015691-2011-15091
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 23, 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

    THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED, AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) REVIEW IS CURRENTLY IN PROCESS.

    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, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ZERO DAYS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE A SIZING ISSUE. ACCORDING TO THE OPERATIVE REPORT, THIS PATIENT HAD SEVERE MITRAL REGURGITATION. MAINLY, THERE APPEARED TO BE SOME INFARCTION OF THE POSTERIOR PAPILLARY MUSCLE AND THE POSTERIOR PAPILLARY MUSCLE COULD BE SLIGHTLY RETRACTED DOWN ALONG WITH POSTERIOR LEAFLET RETRACTION. THE LEAFLET WAS NORMAL. THERE WAS A FAIRLY LARGE CENTRAL MITRAL REGURGITATION. IN ADDITION, THERE WAS SEVERE TRICUSPID REGURGITATION. THE RAMUS BRANCH HAD ABOUT 70% TO 80% STENOSIS. THE PATIENT WAS NOTED TO BE FAIRLY OBESE. THE LEFT VENTRICLE WAS MARKEDLY THICKENED AND THE LATERAL WALL WAS NOT CONTRACTING THAT MUCH. A 30MM MC3 ANNULOPLASTY RING WAS SUTURED THROUGH THE TRICUSPID ANNULUS AND RIGHT ATRIOTOMY WAS CLOSED. AFTER COMING OFF BYPASS THE MITRAL REGURGITATION WAS ONLY TRACE, BUT THERE CONTINUED TO BE SEVERE TRICUSPID REGURGITATION. THEREFORE, THE RIGHT ATRIUM WAS OPENED WITH BEATING HEART AND MC3 30 SIZE RING WAS REMOVED AND A 28MM EDWARDS CLASSIC TRICUSPID ANNULOPLASTY RING WAS SUTURED IN PLACE. THIS HAD COMPLETELY CUT DOWN THE TRICUSPID REGURGITATION. FURTHERMORE, THE SURGEON NOTED THAT THE REASON FOR EXPLANTING THE DEVICE WAS NOT RELATED TO A PRODUCT MALFUNCTION; IT WAS PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4900 R-10C0704

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention