BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1881329 · Received October 7, 2010

    Report

    Report Number
    2953200-2010-01908
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    August 18, 2010
    Report Date
    September 7, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (RESULTS, CONCLUSIONS): INCORRECT REMOVAL OF PROTECTIVE SHEATH. EVALUATION SUMMARY: MEDTRONIC HAS RECEIVED THE RELEVANT DEVICE AND ITS ANALYSIS HAS BEEN COMPLETED. THE STENT WAS RETURNED ON THE STYLETTE COVERED WITH THE PROTECTIVE SHEATH. SOME STENT SEGMENTS WERE SLIGHTLY STRETCHED. THE BALLOON HAD BEEN INFLATED. CRIMP/BAKE IMPRESSIONS WERE EVIDENT ON THE BALLOON.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO DEPLOY A 3.0 MM DIAMETER X 24 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING CORONARY STENT IN TO A PT. HOWEVER, IT WAS REPORTED THAT WHEN THE RELEVANT DEVICE WAS INSERTED IN THE PT, IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. IVUS CONFIRMED THAT THE STENT WAS NOT IN THE VESSEL. THE STENT CAME OFF DURING PREPARATION OF THE RELEVANT DEVICE. THE PT IS REPORTED TO BE FINE AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0002783556

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK