BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ GENESIS AVIATOR 18MM X 7.0 MM

    MDR report key: 615854 · Received June 20, 2005

    Report

    Report Number
    9610978-2005-01446
    Event Type
    Injury
    Date Received
    June 20, 2005
    Date of Event
    May 26, 2005
    Report Date
    June 20, 2005
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INFORMATION FROM THE FIELD STATES THIS PT WAS PRESENTED TO THE INTERVENTIONAL LAB WITH CLAUDICATION OF THE RIGHT ARM. AFTER AN ANGIOGRAM WAS PERFORMED, THE PHYSICIAN FOUND THAT THE INNOMINATE ARTERY CONTAINED A 95% STENOSIS. THE PHYSICIAN PROCEEDED TO PLACE A GENESIS STENT IN THE ARTERY WITH GOOD RESULTS ALTHOUGH A SLIGHT NARROWING REMAINED. A MONTH AFTER THE INDEX PROCEDURE WAS PERFORMED, THE PT STARTED DEVELOPING SYMPTOMS OF CLAUDICATION OF THE RIGHT ARM AND IN 03/2005 GRADIENT PRESSURES WERE CHECKED AND SHOWED A 40MM PRESSURE GRADIENT DIFFERENCE BETWEEN THE ARMS. THE PT WAS BROUGHT BACK ABOUT TEN WEEKS LATER AND A FOLLOW-UP ANGIOGRAM WAS PERFORMED. THIS PROCEDURE SHOWED THAT THE PREVIOUSLY PLACED STENT HAD FRACTURED AND SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS AVIATOR 18MM X 7.0 MM ENDOVASCULAR SDS/STENTS FGE CORDIS EUROPA, N.V. NA R0604788

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L