BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLSTENT ILIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 1744728 · Received July 2, 2010

    Report

    Report Number
    2134265-2009-05183
    Event Type
    Death
    Date Received
    July 2, 2010
    Date of Event
    May 30, 2005
    Report Date
    May 30, 2005
    Manufacturer
    BOSTON SCIENTIFIC IRELAND LTD.
    Product Code
    MAF
    PMA / PMN Number
    P940019
    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 POST A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) THE PATIENT DIED. THE TARGET LESION LOCATION WAS IN THE RIGHT EXTERNAL ILIAC. THE LESION CHARACTERISTICS WERE AN AVERAGE LESION WITH AN INTRALUMINAL DIAMETER THAT WAS 2 MM AND THE TOTAL LESION LENGTH WAS 60 MM. THE WALLSTENT HAD A DIAMETER OF 7MM AND A LENGTH OF 55MM WAS IMPLANTED. THE CLINICAL AND RADIOLOGICAL ASSESSMENT WAS TECHNICALLY SUCCESSFUL AND THERE WERE NO PROCEDURE RELATED COMPLICATIONS. THE CONTROL PERFORMANCE AT DISCHARGE SHOWED THERE WAS EVIDENCE OF IMPROVEMENT IN THE LUMINAL DIAMETER TO LESS THAN OR EQUAL TO 30% RESIDUAL STENOSIS. THERE WAS HEMODYNAMIC SUCCESS AND CLINICAL SUCCESS. AT THE ONE MONTH FOLLOW UP IT WAS DOCUMENTED THAT THE PATIENT HAD DIED IN (B)(6) OF 2005, 24 DAYS AFTER THE INDEX PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ILIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC IRELAND LTD. 71-212

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H