BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 3752227 · Received April 15, 2014

    Report

    Report Number
    2015691-2014-00870
    Event Type
    Injury
    Date Received
    April 15, 2014
    Date of Event
    December 24, 2013
    Report Date
    March 17, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS, MODEL# 2800, PMA# P860057/S001. DEVICE NOT RETURNED. ALTHOUGH THERE HAVE BEEN ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION WAS RECEIVED AND THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THIS EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF TWO (2) MONTHS. THE REASON FOR EXPLANT IS UNKNOWN. THE EXPLANTED DEVICE WAS REPLACED WITH A 23 MM EDWARDS BIOPROSTHESIS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229521 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R