BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 931036 · Received October 19, 2007

    Report

    Report Number
    6000089-2007-01432
    Event Type
    Malfunction
    Date Received
    October 19, 2007
    Date of Event
    September 19, 2007
    Report Date
    October 9, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    SAME CASE AS: 6000084-2007-00055. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED AT A BIFURCATION IN THE SEVERELY CALCIFIED, MODERATELY TORTUOUS DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.50X24 MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN THE DISTAL LAD. THE PHYSICIAN PERFORMED THE KISSING BALLOON TECHNIQUE WITH THE TAXUS STENT AND A STENT DEPLOYED IN THE SECOND DIAGONAL. IVUS CONFIRMED THE STENT STRUT OF THE TAXUS STENT WAS JUTTED INWARD AT THE BIFURCATION. GOOD APPOSITION WAS NOT ACHIEVED. THE ATLANTIS SR PRO CATHETER BECAME STUCK IN THE STENT. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE IMAGING CORE, BUT HE COULDN'T BECAUSE OF A KINK OF THE IVUS CATHETER. A 1.5X15 MM MAVERICK2 BALLOON WAS INTRODUCED AND A GUIDING CATHETER WAS DEEP ENGAGED. THE IVUS CATHETER WAS THEN ABLE TO BE REMOVED. A TOTAL OF FOUR STENTS WERE IMPLANTED DURING THIS PROCEDURE (3 NON-BSC STENTS AND 1 TAXUS STENT). NO PT COMPLICATIONS WERE REPORTED. PT STATUS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 2.50X24 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 YR INFLATION DEVICE: ENCORE26| GETZ BROTHERS| 8F ZUMA2 MEDTRONIC GUIDING CATHETER| RINATO| TERUMO| STENTS: CYPHER| NEO'S| GUIDE WIRES: RUNTHROUGH