BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3926070 · Received July 10, 2014

    Report

    Report Number
    9612164-2014-00805
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    August 1, 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). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (DISSECTION). (B)(4).

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT DRUG ELUTING STENTS WERE IMPLANTED IN THE CX DURING THE INDEX PROCEDURE. IT WAS REPORTED THAT AN ANGIOGRAPHIC COMPLICATION OF DISSECTION OCCURRED DURING INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403369 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005198793

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Hospitalization