BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2080525 · Received April 22, 2011

    Report

    Report Number
    9612164-2011-00292
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    August 21, 2010
    Report Date
    March 29, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: BASED ON THE INFO PROVIDED, NO ROOT CAUSE CAN BE DETERMINED. ACUTE MYOCARDIAL INFARCTION, OCCLUSION OF THE ARTERY. NO PRE-DILATION PRIOR TO USE AS INSTRUCTED IN THE IFU. CONCLUSIONS: BASED ON THE INFO PROVIDED, NO ROOT CAUSE CAN BE DETERMINED.

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RX DRUG ELUTING STENT DIAMETER 3.5MM LENGTH 30MM WAS DEPLOYED BY DIRECT STENTING IN THE RIGHT CORONARY ARTERY RESULTING IN 0% STENOSIS. IVUS CONFIRMED COMPLETE APPOSITION OF THE STENT TO THE VESSEL WALL. THE FOLLOWING DAY, A NON Q-WAVE MI AND SMALL SIDE BRANCH OCCLUSION WERE CONFIRMED. EVENT WAS NOT DEEMED TO BE LIFE THREATENING. EVENT WAS REPORTED NOT TO BE RELATED TO THE PRODUCT OR DRUG BUT TO BE RELATED TO THE PROCEDURE. PT WAS RELEASED FROM THE HOSPITAL. NO ADD'L CLINICAL SEQUELAE WERE REPORTED.

    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 68 YR Hospitalization ASPIRIN| CLOPIDOGREL