BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2229421 · Received August 16, 2011

    Report

    Report Number
    9612164-2011-00941
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    March 10, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT WAS IMPLANTED IN THE MID LAD DURING INDEX PROCEDURE. IT IS REPORTED THAT "THE 1ST DIAGONAL WAS TRAPPED IN STENT JAIL DURING PROCEDURE" THE SIDE BRANCH ARTERY WAS TREATED WITH A BALLOON AND THE PT IS REPORTED TO HAVE RECOVERED WITH TREATMENT. INVESTIGATION HAS INDICATED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE AND THE STUDY PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention