BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1770028 · Received July 25, 2010

    Report

    Report Number
    2134265-2009-06434
    Event Type
    Injury
    Date Received
    July 25, 2010
    Date of Event
    August 22, 2005
    Report Date
    August 22, 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). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT DEVELOPED RESTENOSIS. TARGET LESION 1 WAS IN THE RIGHT CORONARY ARTERY (RCA) WITH A 2.1MM REFERENCE VESSEL DIAMETER AND AN 18MM TARGET LESION LENGTH. PRE-PROCEDURE THERE WAS 77% STENOSIS AND 0% RESIDUAL STENOSIS POST-PROCEDURE. THE LIBERTE STENT WITH A 3MM DIAMETER AND A 28MM LENGTH WAS IMPLANTED. A NON-BSC BALLOON DILATATION CATHETER WAS USED DURING PTA. NO ATTEMPT MADE FOR DIRECT STENTING. NO ADDITIONAL PROCEDURE WAS PERFORMED IN THE TARGET LESION. THE PROCEDURE WAS A TECHNICAL SUCCESS. TARGET LESION 2 WAS IN THE RIGHT CORONARY ARTERY (RCA) WITH A 2.1MM REFERENCE VESSEL DIAMETER AND A 6MM TARGET LESION LENGTH. PRE-PROCEDURE THERE WAS 62% STENOSIS AND 0% RESIDUAL STENOSIS POST-PROCEDURE. THE LIBERTE STENT WITH A 2.75 MM DIAMETER AND AN 8MM LENGTH WAS IMPLANTED. NO ADDITIONAL PROCEDURE WAS PERFORMED IN THE TARGET LESION. THE PROCEDURE WAS A TECHNICAL SUCCESS. PRIOR TO DISCHARGE, THE PATIENT UNDERWENT RE-INTERVENTION OF LESION 1 IN THE TARGET VESSEL ON THE DAY AFTER THE INDEX PROCEDURE DUE TO ANGINAL STATUS AND ANGIOGRAPHIC EVIDENCE OF STENOSIS. VISUAL ESTIMATION OF STENOSIS WAS 90%. THE PATIENT WAS DISCHARGED FOUR DAYS AFTER THE INDEX PROCEDURE WITH NO ANGINAL COMPLAINTS OR SILENT ISCHEMIA. THE DISCHARGE MEDICATIONS WERE ASA 100 MG/DAY FOR 12 MONTHS AND CLOPIDOGREL 75 MG/DAY FOR 12 MONTHS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention SPRINTER BALLOON