BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1081971 · Received July 23, 2008

    Report

    Report Number
    2953200-2008-00574
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 23, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 2.5 MM DIAMETER X 18 MM LENGTH ENDEAVOR RX DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF AN UNK CORONARY LESION. IT WAS REPORTED THAT DELIVERY SYSTEM WAS INSERTED TO THE LESION SITE AND UPON BALLOON INFLATION, THE PHYSICIAN NOTICED THAT THE STENT WAS NOT ON THE BALLOON. THE STENT WAS FOUND OUTSIDE THE PT LOCATED INSIDE OF THE STENT'S PROTECTIVE SHEATH. THE PT IS FINE. MEDTRONIC HAS RECEIVED THE DEVICE AND ITS ANALYSIS HAS BEEN COMPLETED. THE BALLOON HAD BEEN INFLATED. THE STENT WAS PLACED ON THE STYLETTE WITH THE PROTECTIVE SHEATH. THE MID SECTION OF THE STENT WAS STRETCHED AND DEFORMED. THERE WAS CLEAR EVIDENCE OF CRIMP/BAKE IMPRESSIONS ON THE INFLATED BALLOON. ADDITIONAL INFO RECEIVED FROM THE FIELD CONFIRMED THAT THERE WERE NO ISSUES NOTED WHEN TAKING THE DEVICE OUT OF THE PACKAGING OR FROM THE HOOP. IT WAS CONFIRMED BY THE FIELD THAT EXCESSIVE FORCE WAS APPLIED TO REMOVE THE PROTECTIVE SHEATH DURING PREP. PLEASE NOTE THAT THIS DEVICE (LOT NUMBER 0000446391) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000446391

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK