BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2141699 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02477
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - RETURNED PRODUCT CONSISTED OF AN ION STENT DELIVERY SYSTEM (SDS) WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS A BLOOD LIKE SUBSTANCE ON THE OUTER SURFACE OF THE DEVICE. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT IMPLANT SECURE BETWEEN THE MARKERBANDS. THE ENTIRE FIRST DISTAL ROW AND TWO STRUTS IN THE SECOND ROW WERE LIFTED/BENT BACK PROXIMALLY. THERE WAS NO OTHER DAMAGE TO THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD). A 2.5X8MM ION MR STENT DELIVERY SYSTEM WAS ADVANCED AND WOULD NOT CROSS PREVIOUSLY PLACED PROMUS STENT. UPON REMOVAL, A LIFTED STRUT ON THE STENT WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A 2.25X8MM PROMUS WHICH CROSSED THE PLACED STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD). A 2.5X8MM ION MR STENT DELIVERY SYSTEM WAS ADVANCED AND WOULD NOT CROSS PREVIOUSLY PLACED PROMUS STENT. UPON REMOVAL, A LIFTED STRUT ON THE STENT WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A 2.25X8MM PROMUS WHICH CROSSED THE PLACED STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS OK.

    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 H7493902408250 14093840

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR