BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS¿ ELEMENT¿

    MDR report key: 2863403 · Received December 10, 2012

    Report

    Report Number
    2134265-2012-07253
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MDR ID 2134265-2012-07252. IT WAS REPORTED THAT AFTER A PERCUTANEOUS CORONARY INTERVENTION (PCI) STENTING TREATMENT PROCEDURE, THE PATIENT DEVELOPED IN-STENT RESTENOSIS. THE SUBJECT WAS ENROLLED INTO THE (B)(4) (B)(6) 2011. THE TARGET LESION #1 WAS LOCATED IN THE 1ST DIAGONAL WITH 80% STENOSIS AND WAS 25 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A DISTALLY OVERLAPPING 2.50 MM X 24 MM AND 2.50 MM X 12 MM TAXUS ELEMENT STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. IN (B)(6) 2011, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE SUBJECT PRESENTED WITH STABLE ANGINA AND WAS HOSPITALIZED ON THE SAME DAY. SIXTY-NINE PERCENT DIFFUSE IN-STENT STENOSIS LOCATED IN THE 1ST DIAGONAL WAS TREATED WITH BALLOON ANGIOPLASTY, RESIDUAL STENOSIS WAS 0%. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS¿ ELEMENT¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902512250 13710743

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention