BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2585834 · Received May 23, 2012

    Report

    Report Number
    2134265-2012-02892
    Event Type
    Injury
    Date Received
    May 23, 2012
    Date of Event
    February 9, 2011
    Report Date
    April 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. SAME PATIENT AS MDR ID#: 2134265-2012-02396, 2134265-2012-02893, 213465-2012-03193. IT WAS REPORTED THAT FOLLOWING CORONARY ARTERY STENTING TREATMENT PROCEDURES, THE PATIENT HAD TOTAL OCCLUSION IN THE PREVIOUSLY TREATED VESSEL. THE PATIENT HAD A 2.50X20 MM TAXUS STENT PLACED IN THE SAPHENOUS VEIN GRAFT (SVG) TO RIGHT CORONARY ARTERY (RCA) IN (B)(6) 2005 AND A 3.50X20MM TAXUS STENT PLACED IN THE RCA IN (B)(6) 2008. IN (B)(6) 2011, THE PATIENT PRESENTED WITH MID-STERNAL CHEST PRESSURE WITH BILATERAL ARM DISCOMFORT AND ABNORMAL STRESS TEST. CORONARY ANGIOGRAPHY REVEALED TOTALLY OCCLUDED RCA AND SVG TO RCA. THESE LESIONS WERE CHRONICALLY OCCLUDED AND WERE NOT TREATED. NO MORE INFORMATION IS AVAILABLE AT THIS TIME AS THESE TWO PROCEDURES OCCURRED AT AN OUTSIDE HOSPITAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other