BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2882601 · Received December 20, 2012

    Report

    Report Number
    2134265-2012-08270
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    June 22, 2012
    Report Date
    December 4, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: (B)(6) 1939. IF IMPLANTED, GIVE DATE: (B)(6) 2008. DEVICE IS 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 RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME PATIENT AS MDR# 2134265-2009-01574, 2134265-2010-0128, 2134265-2010-02194, 2134265-2012-02584, 2134265-2012-02585, AND 2134265-2012-02586. SAME CASE AS MDR# 2134265-2012-08271 AND 2134265-2012-08269. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCE ANGINA AND VESSEL OCCLUSION OCCURRED. IN (B)(6) 2008, THE PHYSICIAN OBSERVED 75% RESTENOSIS MEASURING 21MM IN LENGTH LOCATED IN THE PREVIOUSLY STENT LAD, WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE PHYSICIAN TREATED THE IN-STENT RESTENOSIS WITH PLACEMENT OF AN UNKNOWN SIZED TAXUS EXPRESS2 STENT, RESULTING IN 0% RESIDUAL STENOSIS. IN (B)(6) 2012, THE PATIENT PRESENTED WITH STABLE ANGINA. STENOSIS AS FOUND IN THE PROXIMAL LAD AND TARGET LESION REVASCULARIZATION WAS PERFORMED. THE 90% STENOSED, 15MM X 3.50MM TARGET LESION WAS TREATED WITH BALLOON ANGIOPLASTY WITH 25% RESIDUAL STENOSIS. THE PATIENT WAS CONSIDERED IMPROVED AND DISCHARGED TWO DAYS LATER. IN (B)(6), NON-TARGET VESSEL REVASCULARIZATION WAS PERFORMED. IN (B)(6) 2012, STENOSIS WAS FOUND IN THE PROXIMAL LAD AND TARGET LESION REVASCULARIZATION WAS PERFORMED. THE PATIENT HAD NO ISCHEMIC SYMPTOMS. THE 90% STENOSED, 15MM X 3.50MM TARGET LESION WAS TREATED WITH BALLOON ANGIOPLASTY WITH 25% RESIDUAL STENOSIS. A ROTOBLATOR AND AN UNSPECIFIED CUTTING BALLOON WERE USED DURING THE PROCEDURE. THE PATIENT WAS CONSIDERED IMPROVED AND DISCHARGED TWO DAYS LATER.

    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 - GALWAY UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention