BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY STENT SYSTEM

    MDR report key: 1080948 · Received July 23, 2008

    Report

    Report Number
    2134265-2008-02066
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    December 4, 2006
    Report Date
    June 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT THROMBOSIS OCCURRED. THE PT PRESENTED WITH AN ACUTE ST ELEVATION MYOCARDIAL INFARCTION. THE 80% THROMBOTIC, ULCERATED, COMPLEX LESION BEING TREATED WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED WITH A 2.57X15MM NON-BSC BALLOON, INFLATED TO 8ATM FOR 30 SECONDS. A 3.50X16MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED AT 20 ATM FOR 30 SECONDS. MULTIPLE DOSES OF NICARDIPINE WERE GIVEN FOR VASODILATION FOLLOWED BY INTRAVENOUS NITROGLYCERIN TO CONTINUE THE PERIPHERAL VASODILATATION. THE LESION WAS POST DILATED WITH A 4.0X14 NON-BSC BALLOON, INFLATED TO 18 ATM FOR 23 SECONDS. MEDICATION: INTEGRILIN, PLAVIX. EIGHT MONTH POST THE TAXUS STENT IMPLANT, PLAVIX WAS DISCONTINUED BY THE PHYSICIAN. THE PT IS TO CONTINUE TAKING ASPIRIN. ONE YEAR AND ONE MONTH POST THE TAXUS STENT IMPLANTED, THE PT EXPERIENCED RECURRENT CHEST PAINS. ONE YEAR AND FIVE MONTHS POST THE TAXUS STENT IMPLANT, THE PT WAS TRANSFERRED FROM ANOTHER HOSPITAL TO THIS FACILITY DUE TO CHEST PAIN AND SHORTNESS OF BREATH. PATIENT IS CURRENTLY TAKING PLAVIX AND ASPIRIN. ANGIOGRAPHY IDENTIFIED A CLOT AT THE ORIGIN OF THE PREVIOUSLY PLACED STENT. A 2.25X15MM NON-BSC BALLOON WAS INFLATED FOUR TIMES TO 14-16 ATM FOR 15-20 SECONDS. AFTER TIMI FLOW II WAS RESTORED, A LARGE AMOUNT OF THROMBUS WAS SEEN. FOUR PASSES WITH A THROMBECTOMY CATHETER WERE MADE. INITIALLY, INSERTION DIFFICULTY WAS EXPERIENCED IN THE DISTAL PORTION OF THE STENOSIS. A 3.5X23MM NON-BSC STENT WAS PLACED ACROSS THE LESION, WITH EXTREME DIFFICULTY DUE TO THE BEND IN THE DISTAL LEFT MAIN, INFLATED TWICE TO 16-20ATM FOR 20 SECONDS. TIMI III FLOW WAS ACHIEVED AND PATENCY WAS RESTORED. UPON DISCHARGE THE PT WAS AMBULATING WELL WITHOUT DIFFICULTY, NO CHEST PAIN, OR SHORTNESS OF BREATH. MEDICATION: LOVENOX, INTEGRILIN.

    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 3.50X16 7475508

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NC STORMER BALLOON| SPRINTER BALLOON