BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2161363 · Received July 13, 2011

    Report

    Report Number
    2134265-2011-02726
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE IS A COMBINATION PRODUCT DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A TAXUS ELEMENT/ION MR STENT DELIVERY SYSTEM (SDS). BLOOD AND CONTRAST WERE IN THE DISTAL AND MID SHAFT OF THE DEVICE WHICH IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE WAS USED. IT WAS DETERMINED THAT ROWS THREE THROUGH FIVE ON THE DISTAL END OF THE STENT HAD STRUTS THAT WERE STRETCHED AND FLARED. THE DISTAL TIP OF THE CATHETER WAS DAMAGED. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY TREATMENT PROCEDURE DIFFICULTY CROSSING OCCURRED. ACCESS WAS GAINED THROUGH THE FEMORAL ARTERY. THE "MODERATELY" STENOSED LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE 2.75X12MM ION MONORAIL DRUG ELUTING STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION, BUT WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER ION STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS FINE. UPON ANALYSIS OF THE RETURNED DEVICE, STENT DAMAGE WAS FOUND.

    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 H7493902412270 13990132

    Patients

    Seq Age Sex Outcome Treatment
    1