BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3931153 · Received July 14, 2014

    Report

    Report Number
    9612164-2014-00900
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    January 13, 2011
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE ¿ (DISSECTION). (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE TWO ENDEAVOR SPRINT DRUG ELUTING STENTS WERE IMPLANTED IN THE RCA . AN ANGIOGRAPHIC COMPLICATION OF DISSECTION OCCURRED DURING THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411309 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR