BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 781091 · Received September 5, 2006

    Report

    Report Number
    6000089-2006-01918
    Event Type
    Malfunction
    Date Received
    September 5, 2006
    Date of Event
    May 26, 2006
    Report Date
    June 30, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND A BREAK OCCURRED IN THE HYPO-TUBE, THE BREAK WAS LOCATED AT APPROXIMATELY 20 CENTIMETERS DISTAL FROM THE STRAIN RELIEF. THE HYPO-TUBE WAS KINKED AT THE POINT OF SEPARATION. MICROSCOPIC EXAMINATION OF THE BALLOON FOUND NO ISSUES WITH THE BALLOON MATERIAL OR THE CRIMPED STENT. THE SHOP FLOOR PAPERWORK WAS REVIEWED FOR THIS PARTICULAR BATCH OF DEVICES (8205308 TOP ASSEMBLY & 8202828 MANIFOLD) AND NO ANOMALIES WERE NOTED FROM THIS REVIEW THAT COULD CORRELATE TO THE DIFFICULTIES THAT WERE EXPERIENCED BY THE PHYSICIAN DURING THE USE OF THIS PRODUCT. THE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON 8/21/2006. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PRODUCT WAS DEFECTIVE. HOWEVER, THE RETURNED PRODUCT CONFIRMED THAT A SHAFT FRACTURE OCCURRED. ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2.75X20MM 8205308

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN