BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

    MDR report key: 1933756 · Received December 16, 2010

    Report

    Report Number
    2953200-2010-02552
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: (NO ROOT CAUSE OF THE EVENT CAN BE DETERMINED BASED ON INFORMATION AVAILABLE) AND (STENT DISLODGEMENT). EVALUATION SUMMARY: THE BALLOON FOLDS WERE PARTIALLY OPENED, THERE WAS NO STENT ON THE BALLOON. CRIMP IMPRESSIONS WERE EVIDENT ALONG THE BALLOON WORKING LENGTH.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO DEPLOY A 2.5 MM DIAMETER X 18 MM LENGTH ENDEAVOR SPRINT OVER THE WIRE (OTW) DRUG ELUTING CORONARY STENT INTO A PT. HOWEVER, IT WAS REPORTED THAT THE RELEVANT STENT DISLODGED IN VIVO. THE PHYSICIAN MADE ATTEMPTS TO GRAB THE DISLODGED STENT WITH A BALLOON, HOWEVER, UNSUCCESSFUL. THE PHYSICIAN INSERTED A 3.0 MM X 15 MM ENDEAVOR STENT AND DEPLOYED IT OVER THE DISLODGED STENT AND IMPLANTED IT INTO THE VESSEL. THE PT IS REPORTED TO BE FINE AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0001132803

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention