BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2840516 · Received November 20, 2012

    Report

    Report Number
    2015691-2012-18677
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    August 29, 2012
    Report Date
    October 24, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT EXPLANTED; EVALUATION NOT POSSIBLE. ADDITIONAL MANUFACTURER NARRATIVE: DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION WAS RECEIVED. THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EDWARDS DEVICE. CONTINUED ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL DETAILS REGARDING THIS CASE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT ANY NEW INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE PATIENT HAD RE-OPERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS AND 9 MONTHS. UNFORTUNATELY, THE REASON FOR RE-OP WAS NOT PROVIDED. DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION WAS RECEIVED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EDWARDS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R