BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1040186 · Received May 8, 2008

    Report

    Report Number
    2134265-2008-01343
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: 2134265-2008-01341, 2134265-2008-01342. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT THROMBOSIS OCCURRED. THE 100% STENOSED LESION BEING TREATED WAS LOCATED IN THE MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH (SIZE AND MANUFACTURER UNK) BALLOON. IVUS WAS PERFORMED. A 2.50 X 24 MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN THE POSTERIOR DESCENDING ARTERY (PDA) TO DISTAL RCA, A 3.00 X 32 MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN THE DISTAL RCA, AND A 3.50 X 32 MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN THE MID RCA. THE STENTS WERE OVERLAPPING. THE STENTS WERE POST DILATED WITH BALLOON (SIZE AND MANUFACTURER UNK). IVUS CONFIRMED THE STENTS WERE WELL APPOSED. MEDICATIONS: TICLOPIDINE AND ASPIRIN. EIGHT MONTHS POST THE INITIAL PROCEDURE, THE PT PRESENTED WITH CHEST PAIN AND EMERGENCY ANGIOGRAPHY WAS PERFORMED. THROMBOSIS WAS IDENTIFIED IN THE MIDDLE OF THE TAXUS STENT WHICH WAS PREVIOUSLY DEPLOYED IN THE DISTAL RCA. THE THROMBOSIS WAS DILATED WITH A BALLOON (SIZE AND MANUFACTURER UNK) AND FLOW WAS IMPROVED.

    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 3.00X32 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention