BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY ST

    MDR report key: 775884 · Received October 31, 2006

    Report

    Report Number
    6000093-2006-02227
    Event Type
    Injury
    Date Received
    October 31, 2006
    Date of Event
    October 2, 2006
    Report Date
    October 2, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PT. THEREFORE NO ANALYSIS COULD BE PERFORMED. BECAUSE THE BATCH NUMBER FOR THIS COMPLAINT IS UNKNOWN, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED. THE CUASE OF THE DIFFICULTIES STATED IN THE COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    SAME CASE AS 6000093-2006-02225 AND 6000093-2006-02226. IT WAS REPORTED THAT APPROX 10 MONTHS AFTER A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. DURING THE INDEX PROCEDURE, THREE UNSPECIFIED TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WERE PLACED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. APPROXIMATELY 8 MONTHS LATER, THE PT DISCONTINUED PLAVIX AND ASPIRIN THERAPY ON HIS OWN. THE PHYSICIAN REPORTED THAT THE PT WAS ALSO USING NON-PRESCRIPTION DRUGS SUCH AS COCAINE. APPROXIMATELY 10 MONTHS AFTER THE INDEX PROCEDURE, THE PT PRESENTED WITH CHEST PAIN AND EXG CHANGES. THROMBOSIS IN THE LAD WAS DIAGNOSED, THE VESSEL WAS 100% OCCLUDED. THE PT WAS ADMINISTERED INTEGRILIN AND HEPARIN PIRIOR TO BEGINNING THE RE-INTERVENTION PROCEDURE. A MAVERICK 3.00X20MM BALLOON WAS USED TO PRE-DILATE THE VESSEL AND FOUR TAXUS EXPRESS2 DES (2.50X24MM, 3.00X32MM, 3.00X28MM AND 3.00X32MM) WERE PLACED IN OVERLAPPING POSITIONS TO TREAT THE THROMBOSIS. TWO QUANTUM MAVERICK BALLOONS (3.0X20MM AND 3.5X20MM) WERE USED TO POST-DILATE THE STENTS. ANGIOGRAPHY REVEALED NO RESIDUAL STENOSIS AND THE PROCEDURE WAS COMPLETED. THE PT CONDITION IS REPORTED AS GOOD. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE AND COREG, ASPIRIN AND DIOVAN WERE ADMINISTERED POST-PROCEDURE. PHYSICIAN OPINION ON RELATIONSHIP OF DEVICE PERFORMANCE TO THE EVENT IS REPORTED AS UNKNOWN RELATIONSHIP.

    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. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R