BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 2070370 · Received April 27, 2011

    Report

    Report Number
    2134265-2011-01531
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K993232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, A INSTENT RESTENOSIS OCCURRED. PATIENT PRESENTED WITH "NOTED CHANGE OF DIALYSIS QUANTITY FLOW, AGGRAVATION OF THE DIALYSIS EFFICIENCY AND RECURRENCE OF THE VEIN HIGH BLOOD PRESSURE." VASCULAR ACCESS WAS OBTAINED VIA THE CEPHALIC VEIN. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON CALCIFIED LEFT CEPHALIC VEIN. A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE WAS PERFORMED TO TREAT THE TARGET LESION. A 014 TRANSCEND GUIDE WIRE WAS ADVANCED AND CROSSED THE TARGET LESION. A 6.0-40/40 BALLOON CATHETER WAS ADVANCED AND INFLATED, HOWEVER A BALLOON RUPTURE OCCURRED ON THE FIRST INFLATION AT 10ATMS. THE BALLOON CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 6.0X40 90CM BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY UNK479

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE WIRE, 014 TRANSEND| BALLOON CATHETER, 6.0-40/40 PATHBLAZER| BALLOON CATHETER, 6.0-40/90 PATHBLAZER| INFLATION DEVICE, EVEREST| INTRODUCER SHEATH, 6F 3CM MEDIKIT