BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1231118 · Received October 30, 2008

    Report

    Report Number
    2134265-2008-04154
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE STENT MOVED ON THE BALLOON. THE 90% STENOSED, MODERATELY CALCIFIED LESION WAS LOCATED IN THE MODERATELY TORTUOUS CIRCUMFLEX VESSEL. THE PHYSICIAN PREDILATED THE LESION WITH A 2.5X12MM NON BSC BALLOON. A TAXUS EXPRESS2 3.50X20MM DRUG ELUTING STENT WAS ADVANCED, HOWEVER, THERE WAS DIFFICULTY PASSING THE STENT DELIVERY SYSTEM (SDS). UPON REMOVAL OF THE SDS, THE STENT STARTED TO SLIP OFF OF THE BALLOON WHEN PULLING THE SDS BACK INTO THE GUIDE CATHETER. THE STENT DID NOT COME COMPLETELY OFF OF THE BALLOON. THE ENTIRE SYSTEM, (GUIDE WIRE, SDS WITH STENT AND GUIDE CATHETER) WAS REMOVED FROM THE PATIENT. THE PHYSICIAN FINISHED THE PROCEDURE USING A NON BSC STENT. PATIENT STATUS AFTER PROCEDURE IS FINE AND STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUT-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 3.50X20MM 11026758

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR SPRINTER: 2.5X12| CYPHER STENT: 3.0X18