BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2200949 · Received August 11, 2011

    Report

    Report Number
    2134265-2011-03253
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RECEIVED PRODUCT CONSISTED OF A TAXUS ELEMENT/ION MONORAIL STENT DELIVERY SYSTEM (SDS), STENT AND SHELF CARTON. THE BATCH NUMBER ON THE SHELF CARTON MATCHED THE REPORTED BATCH NUMBER. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT POSITIONED BETWEEN THE MARKERBANDS. MULTIPLE STENT STRUTS IN THE FIRST THREE ROWS (FROM THE DISTAL EDGE) WERE 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. 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 STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 2.0MM APEX BALLOON CATHETER. A 2.50X16MM ION STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED TO THE RCA AND WOULD NOT CROSS THE LESION. THE SDS WAS PULLED BACK INTO THE GUIDE CATHETER. UPON REMOVAL OF THE SDS IT WAS NOTED THAT THE STENT STRUTS WERE FLARED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 2.0MM APEX BALLOON CATHETER. A 2.50X16MM ION STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED TO THE RCA AND WOULD NOT CROSS THE LESION. THE SDS WAS PULLED BACK INTO THE GUIDE CATHETER. UPON REMOVAL OF THE SDS IT WAS NOTED THAT THE STENT STRUTS WERE FLARED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S 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 H7493902416250 14337168

    Patients

    Seq Age Sex Outcome Treatment
    1 2.0MM APEX BALLOON CATHETER