BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL ELUTING CORONARY STENT SYSTEM

    MDR report key: 1023701 · Received April 1, 2008

    Report

    Report Number
    2134265-2008-00931
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE A SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOLLOWING PREDILATION, THE 2.75X28MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS ADVANCED BUT WOULD NOT CROSS THE LESION. WHEN THE PHYSICIAN PUSHED ON THE STENT DELIVERY SYSTEM (SDS) THE PROXIMAL SHAFT WAS KINKED. THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED. THE SDS WAS ADVANCED TO THE LESION AGAIN BUT IT STILL WOULD NOT CROSS. UPON REMOVAL THE KINKED SEGMENT OF THE SHAFT WAS FRACTURED OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS LISTED 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 2.75X28MM 9418316

    Patients

    Seq Age Sex Outcome Treatment
    1