BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 856655 · Received September 29, 2006

    Report

    Report Number
    6000093-2006-01971
    Event Type
    Malfunction
    Date Received
    September 29, 2006
    Date of Event
    April 16, 2006
    Report Date
    August 31, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SOURCE CONFIRMED THAT THE PRODUCT HAD BEEN DISPOSED AND NO ANALYSIS WAS POSSIBLE. THE MFG RECORDS FOR TOP ASSEMBLY BATCH 8242502 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS NOTICED. THE LESION SITE WAS NOT REPORTED. A BROKEN STRUT WAS NOTICED ON A TAXUS EXPRESS2 2.50X16MM DRUG ELUTING STENT. THE DAMAGE WAS NOTICED WHILE THE DEVICE WAS OUTSIDE OF THE PATIENT'S BODY. THERE WERE NO PATIENT COMPLICATIONS. NO FURTHER INFORMATION COULD BE PROVIDED IN REGARDS TO THE DETAILS OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORPORATION 2.50X16.0MM 8242502

    Patients

    Seq Age Sex Outcome Treatment
    1 YR