BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS¿ ELEMENT¿

    MDR report key: 2516954 · Received April 4, 2012

    Report

    Report Number
    2134265-2012-01881
    Event Type
    Injury
    Date Received
    April 4, 2012
    Date of Event
    January 16, 2012
    Report Date
    March 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT DEVELOPED IN-STENT RESTENOSIS. THE PATIENT PRESENTED AT THE TIME OF THE INDEX PROCEDURE WITH UNSTABLE ANGINA. ANGIOGRAPHY REVEALED THE 95% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. THE LESION MEASURED 20MM IN LENGTH WITH A REFERENCE DIAMETER OF 2.6MM. DIRECT STENTING WAS PERFORMED WITH PLACEMENT OF A 2.75X24MM TAXUS ELEMENT STENT; RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE PATIENT PRESENTED WITH RECURRENT ANGINA PECTORIS. ANGIOGRAPHY REVEALED 75% IN-STENT RESTENOSIS OF THE PROXIMAL RCA. THE PATIENT WAS SCHEDULED FOR AN ELECTIVE PERCUTANEOUS CORONARY INTERVENTION IN (B)(6) 2012, 120 DAYS POST INDEX PROCEDURE. DIRECT STENTING WAS PERFORMED ON THE 95% FOCAL IN-STENT RESTENOSED LESION WITH PLACEMENT OF A 3.0X16MM PROMUS ELEMENT STENT; RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS¿ ELEMENT¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902524270 14298036

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention