BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 976600 · Received January 8, 2008

    Report

    Report Number
    2134265-2008-00075
    Event Type
    Injury
    Date Received
    January 8, 2008
    Date of Event
    December 17, 2007
    Report Date
    December 17, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    SAME CASE AS 2954755-2008-00001. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. THE LESION WAS PRE-DILATED, UNKNOWN TYPE AND SIZE BALLOON. THE PHYSICIAN ATTEMPTED TO PLACE A TAXUS EXPRESS2 3.5X24MM DRUG ELUTING STENT TO THE 95% STENOSED LESION LOCATED IN THE SEVERELY CALCIFIED AND TORTUOUS SAPHENOUS VEIN GRAFT (SVG) TO RIGHT CORONARY ARTERY (RCA) WHERE THERE WAS A PREVIOUSLY PLACED STENT, UNKNOWN TYPE AND SIZE. THE FILTERWIRE WAS PASSED DOWN THE LESION AND THE STENT DELIVERY SYSTEM (SDS) WAS TRACKING OVER THE FILTERWIRE, BUT THE PHYSICIAN FELT RESISTANCE, PULLED BACK, AND THE STENT STRIPPED OFF OF THE DELIVERY SYSTEM. THE PHYSICIAN THEN PULLED THE FILTERWIRE BACK TO ATTEMPT TO CAPTURE THE STENT IN THE FILTERWIRE BASKET, BUT THE BASKET CAME OFF OF THE WIRE AND LODGED IN THE MOST PROXIMAL PART OF THE SVG. SEVERAL ATTEMPTS WERE MADE, WITH DIFFERENT SNARES, TO RETRIEVE THE STENT AND BASKET, BUT WERE UNSUCCESSFUL. THE PHYSICIAN THEN USED A BALLOON, UNKNOWN TYPE AND SIZE, TO CRUSH THE BASKET AND THE STENT TO THE SVG WALL. THE PATIENT REMAINED STABLE THROUGHOUT THE ENTIRE PROCEDURE. PATIENT CONDITION POST PROCEDURE IS NOTED AS FINE.

    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. 3.5X24MM 9758470

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention