BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3921106 · Received July 9, 2014

    Report

    Report Number
    9612164-2014-00743
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    January 17, 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 RCA DURING THE INDEX PROCEDURE. IT IS REPORTED THAT AN ANGIOGRAPHIC COMPLICATION OF DISSECTION OCCURRED. IT IS UNKNOWN IF THE DISSECTION WAS TREATED. ONE DAY LATER THE PATIENT WAS DISCHARGED. THE EVENT WAS NOT ASSESSED FOR RELATEDNESS WITH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399499 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0002414998

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization