BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1040419 · Received May 7, 2008

    Report

    Report Number
    2953200-2008-00292
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    March 19, 2008
    Report Date
    April 7, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 2.5 MM DIAMETER X 18 MM LENGTH ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS IMPLANTED INTO A PT FOR THE TREATMENT OF A CIRCUMFLEX LESION. THE VESSEL MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT 5 DAYS POST STENT IMPLANT THAT THE PT PRESENTED TO THE HOSP WITH CHEST PAIN. THE CINE FILM SHOWED THAT THE STENT APPEARED TO BE FRACTURED. A SECOND ENDEAVOR WAS IMPLANTED INSIDE OF THE FIRST ENDEAVOR. THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2 NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000585497

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK