BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1190298 · Received October 6, 2008

    Report

    Report Number
    2134265-2008-02922
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2008-02921. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, AN ANEURYSM OCCURRED. THE PT PRESENTED WITH UNSTABLE ANGINA. THE 80% STENOSED LESION BEING TREATED WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED WITH A 2.0X12 MAVERICK BALLOON, INFLATED TO 13 ATM. THE PHYSICIAN DEPLOYED A 2.75X28MM TAXUS EXPRESS2 DRUG ELUTING STENT IN THE DISTAL PORTION AND A 3.00X32MM TAXUS EXPRESS2 DRUG ELUTING STENT IN THE PROXIMAL PORTION. POST DILATATION WAS PERFORMED USING A 3.0X12MM QUANTUM MAVERICK BALLOON DISTALLY AND A 3.5X12MM QUANTUM MAVERICK BALLOON PROXIMALLY. FINAL ANGIOGRAPHY REVEALED A RESIDUAL <10% STENOSIS WITH TIMI 3 FLOW. MEDICATION: PLAVIX, AND ASPIRIN. NINE MOS POST THE INITIAL PROCEDURE, AN ANEURYSM OCCURRED. IVUS IDENTIFIED A 3.5MM SACCULAR ANEURYSM AT THE OVERLAPPING STENT SEGMENT. THE PHYSICIAN DEPLOYED A 3.5X16MM NON-BSC STENT. THE STENT WAS POST DILATED WITH THE NON-BSC STENT DELIVERY BALLOON. FINAL ANGIOGRAPHY REVEALED A RESIDUAL <10% STENOSIS WITH TIMI 3 FLOW. MEDICATION: PLAVIX, ASPIRIN, HEPARIN, NITROGLYCERIN, AND ANGIOMAX. PT STATUS REPORTED AS "OK".

    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 3.00X32MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention