BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1770033 · Received July 25, 2010

    Report

    Report Number
    2134265-2009-06452
    Event Type
    Injury
    Date Received
    July 25, 2010
    Date of Event
    August 31, 2005
    Report Date
    August 31, 2005
    Manufacturer
    BOSTON SCIENTIFIC IRELAND LTD.
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN. THEREFORE A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED.THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED IN THE DIRECTION FOR USE (DFU). (B)(4): DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS 2134265-2009-06387. IT WAS REPORTED THAT POST A CORONARY ARTERY STENTING TREATMENT PROCEDURE, CARDIOGENIC SHOCK OCCURRED. TARGET LESION 1 AND 2 WERE LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE FIRST LESION WAS 100% STENOSED AND HAD A REFERENCE VESSEL DIAMETER THAT WAS 2.5MM AND THE LESION LENGTH WAS 22MM. THERE WAS NO ATTEMPT MADE FOR DIRECT STENTING. A 2.50X24MM LIBERTE STENT WAS IMPLANTED. RESIDUAL STENOSIS WAS 3%. THE SECOND LESION WAS 95% STENOSED AND HAD A REFERENCE VESSEL DIAMETER THAT WAS 3MM AND THE LESION LENGTH WAS 22MM. A 3.00X24MM LIBERTE STENT WAS IMPLANTED. RESIDUAL STENOSIS WAS 5%. AN ADDITIONAL PROCEDURE WAS PERFORMED IN LESION 2, AN (IABP) INTRA-AORTIC BALLOON PUMP WAS PLACED DUE TO CARDIOGENIC SHOCK. THE PROCEDURE WAS A TECHNICAL SUCCESS. THE PATIENT WAS DISCHARGED EIGHT DAYS AFTER THE INDEX PROCEDURE WITH NO ANGINAL COMPLAINTS OR SILENT ISCHEMIA. THE PATIENT WAS DISCHARGED WITH THE FOLLOWING MEDICATIONS: ASA 100MG/PER DAY, DURATION: 12 MONTHS AND CLOPIDOGREL 75 MG/DAY FOR 12 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC IRELAND LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention