BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 2001507 · Received February 25, 2011

    Report

    Report Number
    2015691-2011-14905
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    October 11, 2010
    Report Date
    January 28, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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 INITIALLY REPORTED THAT THE DEVICE WAS NOT IMPLANTED. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED AT IMPLANT DUE TO A SIZING ISSUE. ACCORDING TO THE OPERATIVE REPORT: "AN INITIAL ATTEMPT AT REPAIR, WHICH INCLUDED A 34 MM EDWARDS RING TRIANGULAR RESECTION OF P2 LOOKED GOOD ON BULB SYRINGE TESTING, BUT ONCE WE CAME OFF BYPASS THERE WAS A 1+ TO 2+ CENTRAL JET, WHICH I FELT MIGHT WORSEN AND, THEREFORE, WE WENT BACK ON BYPASS AND RE-REPAIRED THE VALVE. ON RE-REPAIR WE NOT ONLY DOWN-SIZED THE RING TO A 30, BUT ALSO PERFORMED SOME LEAFLET PLICATION TO CLOSE SOME CLEFTS IN THE POSTERIOR LEAFLET, WHICH APPEARED TO BE SOURCES OF THE LEAK. AFTER COMPLETION OF THIS REPAIR, THERE WAS NO RESIDUAL LEAK AND THE PATIENT CAME OFF CARDIOPULMONARY BYPASS, WITH INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM DEMONSTRATING NO RESIDUAL LEAK." FURTHERMORE, IT WAS NOTED BY THE SURGEON THAT THERE WAS NO DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 R-10G1791

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention