BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2221051 · Received August 23, 2011

    Report

    Report Number
    2134265-2011-03645
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2011-03644. (B)(6) TRIAL. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED CHEST PAIN. THE INDEX PROCEDURE TREATED THE PROXIMAL CIRCUMFLEX AND MID LEFT ANTERIOR DESCENDING (LAD) WITH TWO TAXUS ELEMENT STENTS RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRING AND CLOPIDOGREL. IN (B)(6) 2011, THE PATIENT RETURNED WITH CHEST PAIN FOR AN ELECTIVE ANGIOGRAM. ANGIOGRAPHY SHOWED MILD CORONARY ARTERY DISEASE AT THE TWO EXISTING STENTS IN THE PROXIMAL TO MID LAD AND OSTIAL CIRCUMFLEX. AN EXERCISE TOLERANCE TEST WAS NEGATIVE FOR ISCHEMIA, BUT THE PATIENT WAS SYMPTOMATICALLY POSITIVE. THERE WERE NO ELEVATED CARDIAC MARKERS. THE PATIENT WAS TO BE MEDICALLY MANAGED WITH AN INCREASED DOSAGE OF ISMN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902512300 13911116

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention