BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3052438 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02148
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    December 21, 2010
    Report Date
    March 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(6). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2010 THE PATIENT PRESENTED WITH CHEST PAIN AND ABNORMAL STRESS TEST. THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. CORONARY ANGIOGRAPHY REVEALED 80% PROXIMAL DIFFUSE IN-STENT RESTENOSIS OF PREVIOUSLY PLACED TAXUS STENT IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE IN-STENT RESTENOSIS WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.0X38 MM TAXUS STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE 70% STENOSED AND 3 MM LONG DE-NOVO TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH A REFERENCE VESSEL DIAMETER OF 4.5 MM. THE TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.50X12 MM TAXUS LIBERTE STENT, RESULTING IN 0% RESIDUAL STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155094 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention