BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1021232 · Received March 28, 2008

    Report

    Report Number
    2953200-2008-00171
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 25, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS - FAILURE TO FOLLOW INSTRUCTIONS (THE INNER POUCH CONTAINS A WARNING LABEL (("THIS PROTECTIVE OUTER POUCH CONTAINS AN INNER POUCH WITH A NON-STERILE EXTERIOR")) IFU STATES THAT THE OUTER SURFACE OF THE INNER POUCH HAS A NON-STERILE EXTERIOR WITH CONTENTS THAT ARE STERILE). CONCLUSIONS - USER ERROR CONTRIBUTED TO EVENT (THE INNER POUCH CONTAINS A WARNING LABEL (("THIS PROTECTIVE OUTER POUCH CONTAINS AN INNER POUCH WITH A NON-STERILE EXTERIOR")) IFU STATES THAT THE OUTER SURFACE OF THE INNER POUCH HAS A NON-STERILE EXTERIOR WITH CONTENTS THAT ARE STERILE).

    Description of Event or Problem · 1

    A 2.5MM DIAMETER X 18MM LENGTH ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT WAS SUCCESSFULLY IMPLANTED INTO A PT FOR THE TREATMENT OF AN UNK LESION. THE LESION MORPHOLOGY IS UNK. IT WAS REPORTED THAT THE INNER POUCH THAT IS IDENTIFIED AS HAVING A NON-STERILE EXTERIOR WITH CONTENTS THAT ARE STERILE; WAS PLACED IN THE STERILE FIELD AND WAS OPENED BY THE SCRUB TECH. THE ENDEAVOR DRUG-ELUTING STENT WAS INSERTED INTO THE PT AND WAS SUCCESSFULLY IMPLANTED AT THE LESION SITE. IT WAS REPORTED AFTER THE CASE, THAT THE NON-STERILE POUCH WAS PUT IN THE STERILE FIELD. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS DOING WELL AND WILL BE MONITORED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2 NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000603196

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention