BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING

    MDR report key: 2060385 · Received April 15, 2011

    Report

    Report Number
    2015691-2011-15245
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    December 13, 2010
    Report Date
    March 3, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K083470
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    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 WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    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 ON THE SAME DAY OF SURGERY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO A SIZING ISSUE. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT PRESENTED WITH SEVERE MITRAL REGURGITATION, AND THEREFORE, WAS REFERRED FOR MITRAL VALVE REPAIR. THE PATIENT HAD A LARGE SEGMENT OF PROLAPSE IN THE P2 SEGMENT OF THE POSTERIOR LEAFLET WITH MULTIPLE RUPTURED CHORDAE. THE EDWARDS RING WAS PLACED AND SALINE TESTING OF THE VALVE APPEARED COMPETENT WITH A GOOD LINE OF COAPTATION. THE PATIENT WAS WEANED OFF CARDIOPULMONARY BYPASS (CPB) TO ASSESS THE VALVE COMPETENCE. THERE APPEARED TO BE GOOD COAPTATION, HOWEVER, THERE WAS A VERY EARLY BRIEF SYSTOLIC JET THAT WENT AWAY VERY EARLY IN SYSTOLE. IT WAS DECIDED TO PLACE THE PATIENT BACK ON CPB AND RE-EXPLORE THE VALVE. THE P1/P2 CLEFT WAS A BIT SLAYED AND UNDER FULL PRESSURE, MAY CAUSE COME LEVEL OF RESTRICTION. THE SECONDARY CHORDS OF THIS CLEFT WAS CUT AND CLOSED WITH INTERRUPTED 5-0 CARDIONYL SUTURES. THE RING WAS ALSO REMOVED AND REPLACED WITH ANOTHER EDWARDS RING, ONE SIZE SMALLER. THE PATIENT WAS WEANED OFF CPB AGAIN, THIS TIME WITH ACCEPTABLE RESULTS. PER THE HEALTH-CARE PROVIDER, THERE WAS NO DEVICE MALFUNCTION; THE RING JUST DIDN'T FIT RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 5200 R-10H2123

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention