BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW

    MDR report key: 1011293 · Received March 11, 2008

    Report

    Report Number
    2953200-2008-00119
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 6, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS AND CONCLUSIONS: LACK OF INFORMATION AND DEVICE NOT RETURNED FOR EVALUATION. STENT DELIVERY CATHETER.

    Description of Event or Problem · 1

    A 2.5 MM DIAMETER X 30 MM LENGTH ENDEAVOR OTW DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PATIENT FOR THE TREATMENT OF AN UNKNOWN LESION. THE VESSEL MORPHOLOGY WAS NOT REPORTED. IT IS UNKNOWN IF THE 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 WHEN BRINGING BACK INTO THE GUIDE CATHETER. AFTER SEVERAL MINUTES THE STENT DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED. THE DEVICE WAS DISCARDED. 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 OTW NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK