BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS¿ ELEMENT¿

    MDR report key: 3043578 · Received April 9, 2013

    Report

    Report Number
    2134265-2013-02220
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6. ) 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2011, THE SUBJECT PRESENTED DUE TO CENTRAL CHEST HEAVINESS AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE DE NOVO TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (PROX RCA) WITH 80% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT PLACEMENT OF A 3.50X12MM TAXUS ELEMENT STENT, WITH 25% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE PATIENT WAS REFERRED FOR SHORTNESS OF BREATH, PRESYNCOPE, ORTHOSTATIC COLLAPSE, CARDIAC CHEST TIGHTNESS AND WAS HOSPITALIZED ON THE SAME DAY. THE CHEST PAIN WAS SUDDEN IN ONSET SHARP INTERMITTENT LEFT SHOULDER PAIN RADIATING UP TO THE NECK. THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. IN (B)(6) 2013, 70% RESTENOSIS OF THE PREVIOUSLY PLACED STUDY STENT WAS NOTED IN THE PROX RCA, WHICH WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 3.5X28MM PROMUS ELEMENT STENT, WITH 0% RESIDUAL STENOSIS. THE EVENTS WERE CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147009 TAXUS¿ ELEMENT¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902512350 14251137

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R