BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1081996 · Received July 23, 2008

    Report

    Report Number
    2953200-2008-00582
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 23, 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
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: 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. EVALUATION: CONCLUSION: 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. (STERILE POUCH INCORRECTLY OPENED)

    Description of Event or Problem · 1

    AN UNKNOWN SIZE ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT WAS SUCCESSFULLY IMPLANTED INTO A PATIENT FOR THE TREATMENT OF AN UNKNOWN LESION. THE LESION MORPHOLOGY IS UNKNOWN. 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 PATIENT AND WAS SUCCESSFULLY IMPLANTED AT THE LESION SITE. IT WAS REPORTED AFTER THE CASE IT WAS FOUND THAT THE NON-STERILE POUCH WAS PUT IN THE STERILE FIELD. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK