BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1790042 · Received August 6, 2010

    Report

    Report Number
    2953200-2010-01497
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    June 30, 2010
    Report Date
    December 19, 2016
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: STENT THROMBOSIS.

    Description of Event or Problem · 1

    ONE ENDEAVOR RX DRUG-ELUTING STENT WAS IMPLANTED IN THE LCX TO TREAT A DISSECTION. IT WAS REPORTED THAT SOME TIME AFTERWARDS STENT THROMBOSIS DEVELOPED HOWEVER, THE PHYSICIAN HAS COMMENTED THAT THE EVENT WOULD NOT BE RELATED TO THE ENDEAVOR RX STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000993987

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention