BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1153384 · Received September 5, 2008

    Report

    Report Number
    2953200-2008-00767
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 8, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: (EMBOLISM-DEVICE), (MODERATE TORTUOSITY AND MODERATE CALCIFICATION WITH 90% STENOSIS). CONCLUSIONS: (MODERATE TORTUOSITY AND MODERATE CALCIFICATION WITH 90% STENOSIS). SECONDARY INTERVENTION.

    Description of Event or Problem · 1

    A 2.5 MM DIAMETER X 12 MM LENGTH ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF AN RCA LESION. LESION MORPHOLOGY WAS REPORTED TO BE MODERATE TORTUOSITY AND MODERATE CALCIFICATION WITH 90% STENOSIS. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE DELIVERY SYSTEM WAS INSERTED; HOWEVER WHILE ATTEMPTING TO CROSS THE LESION, IT GOT CAUGHT AT THE OSTIUM. THE GUIDE CATHETER AND THE DELIVERY SYSTEM WERE REMOVED. IT WAS NOTED UPON REMOVAL THAT THE STENT HAD DISLODGED. THE STENT WAS FOUND IN THE AORTA. THE PHYSICIAN ATTEMPTED TO SNARE THE STENT; AS SOON AS SNARE WENT INTO THE SHEATH, THE STENT WENT DOWNSTREAM. THE STENT REMAINS IN THE PT. THE LESION WAS TREATED WITH TWO STENTS FROM ANOTHER MFR. 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 0000735114

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention