BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3052009 · Received April 11, 2013

    Report

    Report Number
    9612164-2013-00406
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    September 29, 2012
    Report Date
    March 29, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS - INHERENT RISK OF PROCEDURE (MI).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR SPRINT DRUG-ELUTING STENT IMPLANTED IN AN UNKNOWN VESSEL. APPROXIMATELY 25 M ONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED AN MI. THE EVENT WAS NOT ASSESSED FOR RELATEDNESS TO DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155343 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0002688016

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization