BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2874989 · Received December 17, 2012

    Report

    Report Number
    9612164-2012-01783
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    January 11, 2011
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE - (STENT THROMBOSIS AND REVASCULARISATION). (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR SPRINT DRUG ELUTING STENT IMPLANTED IN THE LAD. APPROXIMATELY 14.5 MONTHS POST INDEX PROCEDURE A STENT THROMBOSIS WAS REPORTED TO HAVE OCCURRED. PATIENT UNDERWENT A REVASCULARIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0002997948

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention