BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS? ELEMENT?

    MDR report key: 4223862 · Received November 4, 2014

    Report

    Report Number
    2134265-2014-07014
    Event Type
    Death
    Date Received
    November 4, 2014
    Date of Event
    November 4, 2013
    Report Date
    October 27, 2014
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2014-07015. (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION, THE PATIENT EXPIRED. THE PATIENT PRESENTED IN (B)(6) 2011 WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 3.0X26MM, DE-NOVO, 100% STENOSED TOTAL OCCLUDED TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOLLOWING PRE-DILATION, A 3.0X24MM TAXUS ELEMENT STENT AND A 2.75X12MM TAXUS ELEMENT STENT WERE IMPLANTED IN AN OVERLAPPING MANNER. FOLLOWING POST DILATATION RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON CLOPIDOGREL. IN (B)(6) 2013 THE PATIENT WAS HOSPITALIZED WITH DIAGNOSIS OF CONGESTIVE CARDIAC FAILURE AND ISCHEMIC HEART DISEASE. 759 DAYS POST INDEX PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS RELATED TO THE CONGESTIVE CARDIAC FAILURE AND ISCHEMIC HEART DISEASE.

    Description of Event or Problem · 1

    ADJUDICATION RESULTS WERE UPDATED TO INCLUDE POSSIBLE STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705435 TAXUS? ELEMENT? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902524300 14268114

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death