BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1062034 · Received June 13, 2008

    Report

    Report Number
    2953200-2008-00416
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 15, 2008
    Manufacturer
    MEDTRONIC VCARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS AND CONCLUSION: OTHER - LACK OF INFO (DEVICE NOT RETURNED, NO CDS, FILMS OR OPERATIVE REPORTS WERE PROVIDED).

    Description of Event or Problem · 1

    A 2.5 MM DIAMETER X 24 MM LENGTH ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT SYSTEM WAS IMPLANTED INTO A PT FOR THE TREATMENT OF AN UNKNOWN LESION. THE VESSEL MORPHOLOGY WAS REPORTED TO BE LITTLE CALCIFIED. IT IS UNKNOWN IF LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE ENDEAVOR DRUG-ELUTING STENT DELIVERY SYSTEM WAS INSERTED AND THE STENT WAS SUCCESSFULLY DEPLOYED. THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY SYSTEM AND MET WITH SOME RESISTANCE ON DEFLATION OF THE BALLOON. THE BALLOON WAS INFLATED AND DEFLATED AND RELEASED FROM THE STENT, AND THE STENT DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK