BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY ST

    MDR report key: 771317 · Received October 6, 2006

    Report

    Report Number
    6000093-2006-02018
    Event Type
    Injury
    Date Received
    October 6, 2006
    Report Date
    September 11, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER RELEVANT INFO BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    FACILITY MEDWATCH ATTACHED, REPORT # 1040070. SAME CASE AS MDR #6000093-2006-02017. IT WAS REPORTED PER A FACILITY MEDWATCH THAT THERE WAS OCCLUSION OF THE STENT. THE PT WAS BEING TREATED FOR A 99% IN STENT STENOSIS IN THE MID LEFT CIRCUMFLEX (CX) ARTERY. A TAXUS EXPRESS2 2.5X20MM DRUG ELUTING STENT WAS DEPLOYED AT 16ATM FOR 30 SECONDS. THIS WAS POST DILATED USING A QUANTUM MAVERICK BALLOON INFLATED FOR 30 SECONDS. THEN A 2.50 X 20MM TAXUS EXPRESS2 STENT WAS DEPLOYED AT THE DISTAL END OF 1ST STENT AT 14ATM FOR 30 SECONDS. ANGIOMAX WAS GIVEN. THE PT WAS TRANSFERRED TO THE CCU. THE PT THEN EXPERIENCED CHEST PAIN AND THE EKG SHOWED INFERIOR ST SEGMENT ELEVATION. THREE HOURS LATER THE PT WAS RETURNED TO THE CORONARY CATHETERIZATION LAB AND 100% OCCLUSION OF THE MID LEFT CX WAS FOUND. ANGIOMAX AND REOPRO BOLUSES WERE GIVEN AND ANGIOMAX AND REOPRO DRIPS WERE STARTED. THROMBECTOMY WAS PERFORMED WITH AN EXPORT CATHETER. POST LEFT CORONARY ANGIOGRAPHY SHOWED 0% RESIDUAL STENOSIS AND NO EVIDENCE OF RESIDUAL CLOT IN THE LEFT CX ARTERY. THE PT WAS TRANSFERRED BACK TO "CSSU". PLAVIX WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY ST DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 2.5X20MM 8065427

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention