BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EMBOLIC FILTER

    MDR report key: 2920238 · Received January 10, 2013

    Report

    Report Number
    2017233-2013-00012
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    W.L. GORE & ASSOCAITES
    Product Code
    NTE
    PMA / PMN Number
    K103500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE AND DELIVERY SYSTEM WERE DISCARDED, SO NO ENGINEERING INVESTIGATION COULD BE PERFORMED. THE IMAGING EVALUATION STATED IMAGES PROVIDED ONLY ALLOW FOR EVALUATION OF TORTUOSITY AND CONFIRMATION OF STENOSIS. NO IMAGES OF BALLOON ANGIOPLASTY OR DEVICE DEPLOYMENT ARE AVAILABLE FOR EVALUATION. THERE AS NOT AVAILABLE IMAGES WITH A WIRE ACROSS THE LESION. THERE APPEARS TO BE A LEFT INTERNAL CAROTID ARTERY STENOSIS. THE VESSEL APPEARS TO BE TORTUOUS DISTAL TO THE LESION.

    Description of Event or Problem · 1

    IT WAS REPORTED A PT UNDERWENT CAROTID ARTERY STENTING AND ANGIOPLASTY IN THE (B)(4) STUDY. A GORE EMBOLIC FILTER (GEF) WAS USED FOR EMBOLIC PROTECTION. THE FILTER WAS ADVANCED AND DEPLOYED. DUE TO A TIGHT STENOSIS WITH SEVERE VESSEL ANGULATION, THE STENT COULD NOT BE PLACED AT THE LESION, INITIALLY. THE STENT WAS REMOVED AND THE LESION WAS PREDILATED WITH BALLOON ANGIOPLASTY. THE STENT WAS INTRODUCED AGAIN WITH THE GEF IN PLACE YET THE PT'S TORTUOUS ANATOMY HINDERED IMMEDIATE PLACEMENT, BUT EVENTUALLY SUCCESSFUL STENT PLACEMENT WAS ATTAINED. THE PT EXPERIENCED NEUROLOGICAL DEFICITS DURING POSITIONING OF THE STENT. POST DILATATION WAS ACCOMPLISHED BUT DURING ATTEMPTED REMOVAL OF THE BALLOON, THE BALLOON BROKE FREE WITHIN THE SHAFT OF THE 90CM INTRODUCER SHEATH. A RETRIEVAL CATHETER WAS INTRODUCED BUT COULD NOT BE ADVANCED THROUGH THE SHEATH AND IT EVENTUALLY KINKED. THIS RETRIEVAL CATHETER AND THE INTRODUCER SHEATH WERE REMOVED WITH THE BALLOON INSIDE IT. A SECOND INTRODUCER SHEATH WAS PLACED OVER A .035" BUDDY WIRE FOLLOWED BY A SECOND RETRIEVAL CATHETER. THIS RETRIEVAL CATHETER COULD NOT BE ADVANCED PAST THE STENT, SO IT WAS REMOVED ALSO. ANOTHER FILTER RETRIEVAL CATHETER WAS ADVANCED THROUGH THE SHEATH AND THE GEF WAS REMOVED SUCCESSFULLY. THE PT'S NEUROLOGICAL SYMPTOMS RESOLVED AND HE RETURNED TO BASELINE VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14016 GORE EMBOLIC FILTER NTE/TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE W.L. GORE & ASSOCAITES 10589702

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other SPIDER FILTER RETRIEVAL CATHETER| ACCULINK STENT