BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 6840182 · Received September 1, 2017

    Report

    Report Number
    2015691-2017-02766
    Event Type
    Injury
    Date Received
    September 1, 2017
    Date of Event
    June 1, 2017
    Report Date
    August 10, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #2800; BRAND NAME: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS; PMA #P860057/S001. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HEALTHCARE PROVIDER. THERE HAS BEEN NO RESPONSE AT THIS TIME. THERE IS CURRENTLY INSUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE OF THIS EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT THIS VALVE MODEL 290023MM WAS EXPLANTED AFTER AN IMPLANT DURATION OF 21 (TWENTY-ONE) DAYS FOR UNKNOWN REASON. A MODEL 290021MM WAS IMPLANTED IN REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617815 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R