BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX MITRAL ANNULOPLASTY RING

    MDR report key: 3436132 · Received October 29, 2013

    Report

    Report Number
    2015691-2013-21416
    Event Type
    Injury
    Date Received
    October 29, 2013
    Date of Event
    September 27, 2013
    Report Date
    September 30, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K083623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. THE CUSTOMER WAS ASKED AND HAS AFFIRMED THAT THERE WAS NO MALFUNCTION OF THE DEVICE AND THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE PATIENT STATUS WAS REPORTED AS UNDER TREATMENT AT (B)(6) 2013. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED AT THE HOSPITAL. ECHO REPORT WILL NOT BE PROVIDED. CONCLUSION: THERE ARE MANY FACTORS THAT COULD RESULT IN THE NEED TO EXPLANT AN ANNULOPLASTY RING AND REPLACE WITH A BIOPROSTHETIC VALVE, 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. THE SURGEON HAS INDICATED THAT THE DEVICE HAD PULLED AWAY FROM THE ANNULUS, MOST LIKELY DUE TO FRIABLE TISSUE. WITHOUT ADDITIONAL INFORMATION AND RETURN OF THE DEVICE, WE ARE UNABLE TO CONCLUSIVELY DETERMINE ROOT CAUSE FOR EXPLANT OF THIS DEVICE.

    Description of Event or Problem · 1

    REPORTEDLY, A 28MM RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 10 MONTHS DUE TO DEHISCENCE AND MITRAL REGURGITATION (MR). THE CUSTOMER REPORTED THAT AN IMR RING, MODEL 4100M28, WAS IMPLANTED FOR MITRAL ANNULOPLASTY (MAP) TO CORRECT MR ON (B)(6) 2012. ON (B)(6) 2013, THE RING WAS EXPLANTED AND REPLACED WITH A MAGNA MITRAL EASE VALVE, (B)(4). AT EXPLANT, IT WAS FOUND THAT THE IMR RING WAS PARTIALLY DETACHED FROM THE ANNULUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554499 CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX MITRAL ANNULOPLASTY RING RING, ANNULOPLASTY KRH EDWARDS LIFESCIENCES 4100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R