BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY STENT SYSTEM

    MDR report key: 1063298 · Received June 19, 2008

    Report

    Report Number
    2134265-2008-01735
    Event Type
    Death
    Date Received
    June 19, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 NAY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2008-01736. IT WAS REPORTED THAT POST A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT THROMBOSIS AND PT DEATH OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE 90% STENOSED MODERATELY TORTUOUS AND CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE 95% STENOSED MODERATELY TORTUOUS AND CALCIFIED MID RIGHT CORONARY ARTERY (RCA). THE LESIONS WERE PREDILATED WITH A 2.5X10MM NON BSC DEVICE AND THEN THE 2.50X20MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE RCA AND A 2.50X16MM TAXUS EXPRESS2 DES WAS IMPLANTED IN THE LAD. THE ARTERIES WERE OPEN AND LOOKING GOOD AND THE PROCEDURE WAS COMPLETED. IT WAS NOTED THAT THE PT IMMEDIATELY BEGAN "BREAKING OUT IN HIVES" ALL OVER THE TORSO AND BACK. THE PT CONTINUED EXPERIENCING HIVES AND THEY WORSENED OVER THE NEXT FIVE DAYS. THE PHYSICIAN WAS EVENTUALLY ABLE TO CONTROL THE HIVES AND SENT THE PT HOME. THE PT RETURNED THE NEXT DAY WITH AN ACUTE MYOCARDIAL INFARCTION. UPON ANGIOGRAM, IT WAS NOTICED THAT BOTH TAXUS EXPRESS2 STENTS HAD THROMBOSED ON THE PROXIMAL EDGE OF THE STENTS. CPR WAS STARTED ON THE PT AND THEN THE PHYSICIAN ATTEMPTED TO COMPLETE A BALLOON ANGIOPLASTY WITH A NON BSC BALLOON. A 2.5X23MM NON BSC STENT WAS ALSO INSERTED, BUT WAS UNABLE TO BE DEPLOYED. THE STENT WAS REMOVED AND THE NON BSC BALLOON WAS INSERTED AGAIN AND INFLATED SEVERAL TIMES; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL AND THE PT EXPIRED ON THE TABLE.

    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 2.50X20MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R CHOICE PT ANGIOSCULPT BALLOON| 2.5X15MM SPRINTER BALLOON| 2.5X23MM VISION STENT| BRITE TIP GUIDE WIRE