BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 828786 · Received February 6, 2007

    Report

    Report Number
    6000089-2007-00171
    Event Type
    Malfunction
    Date Received
    February 6, 2007
    Date of Event
    October 13, 2006
    Report Date
    January 18, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS COULD NOT REMOVE THE GUIDEWIRE FROM THE DEVICE. VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE REVEALED A MID-SHAFT EXTRUSION BREAK MEASURING APPROXIMATELY 1.5CM PROXIMAL TO THE PORT. THE ENTIRE LOWER DISTAL SUB-ASSEMBLY WAS STRETCHED AND BUNCHED TOGETHER, WITH THE INNER CORE WIRE BROKEN. VISUAL AND MICROSCOPIC EXAMINATION OF THE STENT REVEALED DAMAGE TO THE PROXIMAL END. THE PROXIMAL STENT STRUTS WERE BUNCHED TOGETHER AT THE CENTER OF THE STENT. THE BALLOON WAS VISUALLY AND MICROSCOPICALLY EXAMINED. NO VISUAL DEFECTS WERE OBSERVED UNDER MAGNIFICATION. THE BALLOON WAS TIGHTLY WRAPPED AND DID NOT APPEAR TO HAVE BEEN SUBJECTED TO ANY POSITIVE PRESSURE. A RECOMMENDED SIZE GUIDEWIRE (0.014 INCH) WAS INSERTED THROUGH THE GUIDEWIRE LUMEN WITH NO RESTRICTIONS NOTED. TOP ASSEMBLY BATCH # 8781041 HAS NOT ASSOCIATED COMPLAINTS AT THIS TIME. A REVIEW OF THE SHOP FLOOR PAPERWORK FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATCH # 8781041 AND SUB-ASSEMBLY BATCH # 8752116 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE ROOT CAUSE OF THE COMPLAINT INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE ANALYSIS COMPLETED ON 01/18/2007. IT WAS REPORTED, THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE 2.50X12MM TAXUS DRUG ELUTING STENT GOT STUCK ON THE GUIDE WIRE. HOWEVER, THE RETURNED PRODUCT REVEALED THAT THERE WAS STENT DAMAGE AND SHAFT FRACTURE. WHILE ATTEMPTING TO TREAT A LESION IN THE CIRCUMFLEX (CX), THE PHYSICIAN PUT THE 2.50X12MM TAXUS STENT OVER THE NON-BSC WIRE AND "THE STENT BECAME STUCK ON THE WIRE. THE WHOLE SYSTEM WAS PULLED OUT WITHOUT COMPLICATIONS." THEN A 2.5X8MM TAXUS EXPRESS2 STENT WAS DEPLOYED IN THE LESION LOCATION IN THE CX "WITHOUT ANY PROBLEMS." THEN A 3.0X32MM TAXUS EXPRESS2 STENT WAS ATTEMPTED TO BE PLACED IN THE OBTUSE MARGINAL (OM), BUT THE STENT STUCK ON THE WIRE. IT WAS REMOVED FROM THE PATIENT AND REMOVED FROM THE WIRE. THE SAME 3.0X32MM TAXUS STENT WAS THEN SUCCESSFULLY DEPLOYED IN THE RIGHT CORONARY ARTERY. NO PATIENT COMPLICATION WERE REPORTED, AND THE PATIENT CONDITION WAS REPORTED AS "OKAY."

    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 CORP. 2.50X12MM 8781041

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR WHISPER WIRE