BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE FLOW REVERSAL SYSTEM

    MDR report key: 2413325 · Received January 5, 2012

    Report

    Report Number
    2017233-2012-00007
    Event Type
    Malfunction
    Date Received
    January 5, 2012
    Date of Event
    December 8, 2011
    Report Date
    December 8, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NTE
    PMA / PMN Number
    K083300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CASE IMAGES HAVE BEEN RECEIVED FOR EVALUATION. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED A PT UNDERWENT CAROTID ARTERY ANGIOPLASTY; A GORE FLOW REVERSAL SYSTEM WAS SELECTED FOR EMBOLIC PROTECTION. THE PT PRESENTED WITH A RESTENOSIS OF A STENT PLACED IN THE CAROTID BIFURCATION. THE GORE BALLOON WIRE (GBW) BALLOON WAS INFLATED. IMAGING REVEALED THE BALLOON WAS OVERINFLATED; HOWEVER, THE PHYSICIAN CHOSE TO CONTINUE THE PROCEDURE. FOLLOWING GUIDEWIRE INTRODUCTION INTO THE INTERNAL CAROTID ARTERY, THE GBW APPEARED TO RUPTURE. THE GBW WAS REMOVED AND AN EMBOLIC FILTER WAS PLACED TO CONTINUE THE PROCEDURE, WHICH CONCLUDED WITH NO ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE FLOW REVERSAL SYSTEM NTE/TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE W.L. GORE & ASSOCIATES WLG380 9074093

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other ANGIOPLASTY BALLOONS