BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1011302 · Received March 11, 2008

    Report

    Report Number
    2953200-2008-00116
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 12, 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
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: (LACK OF INFO AND DEVICE NOT RETURNED FOR EVAL) CONCLUSIONS: (LACK OF INFO AND DEVICE NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    A 3.0 MM DIAMETER X 30 MM LENGTH ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT DELIVERY SYS WAS INSERTED INTO A PT FOR THE TREATMENT OF AN UNK LESION. THE VESSEL MORPHOLOGY WAS NOT REPORTED. IT IS UNK IF THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE ENDEAVOR DRUG-ELUTING STENT DELIVERY SYS WAS INSERTED AND THE STENT WAS SUCCESSFULLY DEPLOYED AT THE LESION SITE. THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY SYS AND MET WITH SOME RESISTANCE WHEN BRINGING BACK INTO THE GUIDE CATHETER. AFTER SEVERAL MINUTES AND PULLING RATHER HARD THE STENT DELIVERY SYS WAS SUCCESSFULLY REMOVED. THE DEVICE HAS BEEN DISCARDED. NO ADD'L 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 CARDIOVASCULAR GALWAY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK