BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS¿ ELEMENT¿ LONG

    MDR report key: 2961964 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00639
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    November 27, 2012
    Report Date
    January 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. THE MANUFACTURING BATCH RECORD REVIEW CONFORMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THE REPORTED EVENT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE PRODUCT DIRECTIONS FOR USE (DFU) AND/OR DEVICE LABELING. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS MDR ID#: 2134265-2013-00638. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT IN-STENT RESTENOSIS AND REQUIRED A TARGET VESSEL REVASCULARIZATION (TVR). IN (B)(6) 2011, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION IIIB) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 1ST DE NOVO TARGET LESION WAS A LONG LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (MID RCA) WITH 70% STENOSIS AND WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.80MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 3.00X38MM TAXUS ELEMENT STENT, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE 2ND DE NOVO TARGET LESION WAS A LONG LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (MID RCA) WITH 70% STENOSIS AND WAS 23MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.4MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 3.50X38MM TAXUS ELEMENT STENT, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE PATIENT WAS HOSPITALIZED AND REFERRED FOR CARDIAC CATHETERIZATION. CORONARY ANGIOGRAPHY REVEALED 70% FOCAL RESTENOSIS OF THE PREVIOUSLY PLACED STUDY STENT IN THE MID RCA, WHICH WAS TREATED WITH BALLOON ANGIOPLASTY, WITH 0% RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED AS RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65253 TAXUS¿ ELEMENT¿ LONG CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902538350 13379949

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R