BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 819222 · Received February 1, 2007

    Report

    Report Number
    6000093-2007-00241
    Event Type
    Malfunction
    Date Received
    February 1, 2007
    Date of Event
    December 26, 2006
    Report Date
    January 23, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: PRODUCT ANALYSIS COULD NEITHER CONFIRM NOR DENY THE CROSSING DIFFICULTY AS STATED IN THE COMPLAINT. VISUAL EXAMINATION OF THE STENT REVEALED DAMAGE TO THE PROXIMAL END. THE PROXIMAL STENT STRUTS WERE BENT. 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. THERE IS NO EVIDENCE THAT THE DEVICE WAS IMPROPERLY MANUFACTURED. DAMAGE OF THIS NATURE IS USUALLY THE RESULT OF PULLING AN UN-EXPANDED STENT BACK INTO THE GUIDE CATHETER. THE EXACT CAUSE OF THE STENT DAMAGE COULD NOT BE DETERMINED. THE MFG RECORDS FOR BATCH 8232905 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS AT THE TIME OF ITS RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON 01/23/2007. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE STENT COULD NOT CROSS THE LESION. AFTER PRE-DILATING THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS RIGHT CORONARY ARTERY, THE PHYSICIAN ATTEMPTED TO PLACE A 4.50 X 16MM TAXUS EXPRESS2 DRUG ELUTING STENT, BUT HAD DIFFICULTY CROSSING THE LESION. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PT'S CONDITION IS REPORTED AS "GOOD". HOWEVER, THE RETURNED PRODUCT CONFIRMED THAT THERE WAS PROXIMAL STENT DAMAGE.

    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. 4.50 X 16MM 8232905

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR