BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2213071 · Received August 16, 2011

    Report

    Report Number
    2134265-2011-03325
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: RECEIVED PRODUCT CONSISTED OF A TAXUS ELEMENT/ION OVER THE WIRE STENT DELIVERY SYSTEM AND STENT. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT POSITIONED BETWEEN THE MARKERBANDS. THERE WERE THREE STENT STRUTS STRETCHED DISTALLY. FURTHER INSPECTION PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. BECAUSE THE DEVICE WAS REPORTEDLY USED IN COMBINATION WITH AN INCOMPATIBLE GUIDE CATHETER, WHICH MAY HAVE CONTRIBUTED TO THE CONFIRMED STENT DAMAGE, THE ROOT CAUSE CLASSIFICATION IS USER RELATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE RIGHT CORONARY ARTERY. USING AN UNSPECIFIED 5F GUIDE CATHETER, THE PHYSICIAN ADVANCED THE 38MM X 2.75MM ION STENT DELIVERY SYSTEM (SDS) TO THE TARGET LESION. HOWEVER THE SDS WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE STENT STRUTS WERE LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902338270 14352192

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR