BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT CORONARY STENT GRAFT

    MDR report key: 443331 · Received February 14, 2003

    Report

    Report Number
    9616290-2003-00002
    Event Type
    Injury
    Date Received
    February 14, 2003
    Date of Event
    February 2, 2003
    Report Date
    February 10, 2003
    Manufacturer
    JOMED GMBH
    Product Code
    MAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE STENT SEPARATED FROM THE BALLOON, UNABLE TO RETRIEVE THE STENT. FLUOROSCOPY DONE OF CORONARIES AND GROIN AT SHEATH SITE, PATIENT TO O.R. THE JOSTENT WAS NOT DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT CORONARY STENT GRAFT CORONARY STENT GRAFT MAF JOMED GMBH 010CG16UA 126562

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization MAVERICK 3.0 X 20MM BALLOON.