BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3090565 · Received May 2, 2013

    Report

    Report Number
    2134265-2013-02839
    Event Type
    Injury
    Date Received
    May 2, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). EVENT DATE: (B)(6) 2007. IF IMPLANTED, GIVE DATE: (B)(6) 2005. 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). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, TARGET VESSEL RESTENOSIS OCCURRED. IN (B)(6) 2005, THE PATIENT WAS DIAGNOSED WITH NON-Q WAVE MYOCARDIAL INFARCTION. OCCLUSION OF THE SAPHENOUS VEIN GRAFT (SVG) TO RAMUS INTERMEDIUS WAS NOTED, WHICH WAS TREATED WITH THE PLACEMENT OF A 2.75X12MM UNKNOWN TAXUS DRUG ELUTING STENT. IN (B)(6) 2007, CARDIAC CATHETERIZATION REVEALED OSTIAL OCCLUSION IN THE SVG TO RAMUS INTERMEDIUS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192124 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 Other