BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EMBOLIC FILTER

    MDR report key: 2850831 · Received November 21, 2012

    Report

    Report Number
    2017233-2012-00776
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NTE
    PMA / PMN Number
    K103500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECS. THE DEVICE WAS DISCARDED, SO NO ENGINEERING INVESTIGATION COULD BE PERFORMED. THE IMAGING REVIEW IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED A PT WITH A PREVIOUS ENDARTERECTOMY UNDERWENT CAROTID ARTERY STENTING AND ANGIOPLASTY. A GORE EMBOLIC FILTER (GEF) WAS USED FOR EMBOLIC PROTECTION. THE FILTER WAS ADVANCED AND DEPLOYED AND STENT PLACEMENT WAS SUCCESSFUL. AN ATTEMPT WAS MADE TO COLLAPSE THE FILTER AND REMOVE IT, BUT INTERACTION WITH THE STENT PREVENTED REMOVAL. AN EMBOSHIELD RETRIEVAL CATHETER WAS INTRODUCED AND THE FILTER WAS REMOVED SUCCESSFULLY. AFTER REMOVAL OF THE FILTER, THE SHUTTLE SHEATH DELIVERY SYSTEM WAS REMOVED AND THE PT EXHIBITED A STROKE. THE PT WAS INTUBATED FOR FURTHER INTERVENTION TO EVACUATE A CLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EMBOLIC FILTER NTE / TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE W.L. GORE & ASSOCIATES 10379141

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other