BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 3900065 · Received June 27, 2014

    Report

    Report Number
    2015691-2014-01481
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K923367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THERE IS INSUFFICIENT INFORMATION PROVIDED IN THE RESPONSE FROM THE SURGEON TO INDICATE THE REASON FOR EXPLANT. HE DID INDICATE THAT THE DEVICE WAS NOT AVAILABLE FOR RETURN AND EVALUATION BECAUSE IT WAS DISCARDED. THE INFORMATION INDICATING THIS DEVICE WAS EXPLANTED WAS LEARNED THROUGH NOTIFICATION TO OUR IMPLANT PATIENT REGISTRY OF ANOTHER DEVICE IMPLANTED IN THE SAME POSITION. THE RESPONSE FROM THE SURGEON INDICATED THAT ANOTHER DEVICE HAD BEEN IMPLANTED IN THE INTERIM; THEREFORE, THE EXPLANT DATE OF THIS DEVICE REMAINS UNKNOWN. THERE WERE NO RECORDS TO SUPPORT THE EXPLANT PROCEDURE SINCE IT WAS CONDUCTED BY A DIFFERENT SURGEON AT ANOTHER MEDICAL FACILITY. THE INTERIM DEVICE IS NOT AN EDWARDS DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE IN THE PATIENT FILE REGARDING HISTORY OF THE EXPLANTED ANNULOPLASTY RING. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN STARTED. NO PRODUCT EVALUATION WILL BE DONE AS THE ANNULOPLASTY RING HAS REPORTEDLY BEEN DISCARDED. THERE ARE MANY FACTORS THAT COULD RESULT IN THE NEED TO EXPLANT AND REPLACE AN ANNULOPLASTY RING, THE MOST COMMON OF WHICH IS REGURGITATION. THESE COMPLICATIONS CAN HAVE MANY ROOT CAUSES, INCLUDING BUT NOT LIMITED TO PATIENT FACTORS, (AGE, DISEASE STATES, COMORBIDITIES), PHARMACOLOGICAL FACTORS, OR PROCEDURE FACTORS. IT IS TYPICALLY NOT RELATED TO PRODUCT MALFUNCTION. WITHOUT ADDITIONAL INFORMATION FROM THE HEALTH CARE PROVIDER, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR EXPLANT OF THIS DEVICE.

    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 LEARNED THROUGH ITS IMPLANT PATIENT REGISTRY OF A MODEL 4600 RING THAT WAS EXPLANTED AFTER AN UNKNOWN PERIOD OF TIME DUE TO A MITRAL VALVE REPAIR FAILURE. THIS 30MM ANNULOPLASTY RING WAS EXPLANTED AND REPLACED WITH A MECHANICAL VALVE. THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER, IT WAS INDICATED THERE WAS A MALFUNCTION DUE TO "SVD SOME YEARS LATER REQUIRING REPLACEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378264 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM RING, ANNULOPLASTY KRH EDWARDS LIFESCIENCES 4600

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R