BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS¿ ELEMENT¿

    MDR report key: 3052090 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02635
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    September 7, 2011
    Report Date
    March 14, 2013
    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 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 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). IT WAS REPORTED POST A PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH STENT IMPLANTATION IN-STENT RESTENOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A TAXUS ELEMENT STENT 24X2.50MM WAS IMPLANTED. ON (B)(6) 2011 SEVERE STENOSIS AT THE OSTIUM OF THE LAD WITH SOME SUGGESTION OF PROXIMAL INSTENT RESTENOSIS WAS NOTICED. A POST-DILATION WAS PERFORMED WITH A 3.75 X 12 MM NON-COMPLIANT BALLOON AND IMPLANTATION OF A 3.5 X 11 MM STENT WITH GOOD ANGIOGRAPHIC RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156934 TAXUS¿ ELEMENT¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902524250 13429613

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention