BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2191746 · Received August 4, 2011

    Report

    Report Number
    2134265-2011-03144
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT POSITIONED BETWEEN THE MARKERBANDS. THE HYPO-TUBE WAS KINKED 62 AND 64 CM FROM THE STRAIN RELIEF. A BLUE FIBROUS PIECE OF FOREIGN MATERIAL WAS LODGED IN THE EXCHANGE PORT. FURTHER INSPECTION PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A CORONARY ARTERY STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS DISCOVERED. THE LESION BEING TREATED IS UNKNOWN. THE PHYSICIAN WAS TRYING TO IMPLANT A 2.25X12MM ION STENT. DURING VISUAL INSPECTION OF THE STENT DURING PREP THE PHYSICIAN NOTICED ON THE DISTAL END, THE STENT STRUTS WERE FLARED. THE PHYSICIAN GRABBED ANOTHER OF THE SAME DEVICE TO COMPLETE THE CASE. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT'S STATUS OKAY.

    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 H7493902412220 14013702

    Patients

    Seq Age Sex Outcome Treatment
    1