BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRANSEND EX .014"/205 SOFT TIP

    MDR report key: 936963 · Received October 31, 2007

    Report

    Report Number
    6000078-2007-00271
    Event Type
    Death
    Date Received
    October 31, 2007
    Date of Event
    August 29, 2007
    Report Date
    October 4, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV.
    Product Code
    DQX
    PMA / PMN Number
    K022357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR TECHNICAL ANALYSIS AS IT WAS DISPOSED OF BY THE HOSP. THEREFORE, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE.

    Description of Event or Problem · 1

    IN 2007, A PT PRESENTED TO THE EMERGENCY ROOM LATE IN THEIR STROKE WITH ACUTE (THROMBUS) SYMPTOMS DUE TO RIGHT MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION. THE PATIENT WAS TAKEN TO ANGIOGRAPHY FOR THROMBOLYTIC INFUSION IN ORDER TO OPEN THE RIGHT MCA THROMBUS FOLLOWED BY ANGIOPLASTY. AS A LAST RESORT TO OPEN THE VESSEL AN INTRAVASCULAR STENT (OFF-LABEL) WAS PLACED IN THE MCA. THE STENT DEPLOYED WITHOUT DIFFICULTY. POST PROCEDURE CT SCAN SHOWED A HEMORRHAGE DISTAL TO THE STENT WHICH THE PHYSICIAN NOTED MAY HAVE RESULTED FROM WIRE MANIPULATION AS HE HAD MANIPULATED THE GUIDEWIRE DISTAL TO THE STENT. PATIENT EXPIRED TWO DAYS POST PROCEDURE. ADDITIONAL INFO OBTAINED FROM THE USER FACILITY VERIFIED THAT TWO TRANSEND WIRES WERE USED IN THE PROCEDURE, HOWEVER, THEY DID NOT NOTE WHICH OF THE TWO WIRES WAS IN USE AT THE TIME THE VESSEL WAS PENETRATED. THERE WERE NO PROBLEMS WITH THE FUNCTION OF EITHER GUIDEWIRE. THE USER FACILITY POSTULATED THAT TECHNIQUE MAY HAVE BEEN A CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND EX .014"/205 SOFT TIP (74 HAP) GUIDEWIRE DQX BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV. 46-806 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death TRANSEND EX .014"/205 SOFT TIP| WINGSPAN STENT SYSTEM