BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1071611 · Received July 9, 2008

    Report

    Report Number
    2953200-2008-00528
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 12, 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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS/CONCLUSIONS: (THE INNER POUCH CONTAINS A WARNING LABEL (("THIS PROTECTIVE OUTER POUCH CONTAINS AN INNER POUCH WITH 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 AS INSERTED INTO THE PATIENT AND WAS SUCCESSFULLY IMPLANTED AT THE LESION SITE. IT WAS REPORTED AND FOUND AFTER THE CASE THAT THE NON-STERILE POUCH WAS PUT IN THE STERILE FIELD. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WAS PUT ON ANTIBIOTICS; 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention