BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EMBOLIC FILTER

    MDR report key: 3565381 · Received December 26, 2013

    Report

    Report Number
    2017233-2013-00807
    Event Type
    Injury
    Date Received
    December 26, 2013
    Date of Event
    December 4, 2013
    Report Date
    January 6, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    NTE
    PMA / PMN Number
    K103500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS: THERE IS NO CLEAR EVIDENCE THAT INDICATES INCONSISTENCIES IN MANUFACTURING OR PRODUCT DEFECT LED TO THE RETRIEVAL DIFFICULTY. ATTEMPTED RETRIEVAL OF THE RETURNED DEVICE REVEALED IN-FOLDING OF THE CATHETER TIP. IN ADDITION, A FRAME FRACTURE WAS OBSERVED. THESE ISSUES COULD POTENTIALLY LEAD TO DIFFICULTY RETRIEVING THE DEVICE; HOWEVER, IT IS NOT KNOWN IF THAT WAS THE STATE OF THE DEVICE DURING THE REPORTED DIFFICULTY. THERE WERE NO VISIBLE IRREGULARITIES REPORTED UPON OPENING OF THE DEVICE PACKAGE OR DURING LOADING INTO THE DELIVERY CATHETER. THE RECOMMENDED ACTIONS ARE TO MONITOR COMPLAINT DATA FOR NOTICEABLE SHIFTS OR TRENDS WITH REGARD TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    RESULTS - A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE IS CURRENTLY IN PROGRESS. AN ENGINEERING INVESTIGATION FOR THE DEVICE IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT 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; HOWEVER, AFTER STENT PLACEMENT, DURING FILTER RETRIEVAL, THE FILTER BECAME CAUGHT ON THE STENT, CAUSING THE STENT TO BE PARTIALLY COMPRESSED IN LENGTH. THE FILTER WAS EVENTUALLY REMOVED WHILE PARTIALLY ENCLOSED IN THE RETRIEVAL CATHETER. AN ATTEMPT TO REVISE THE PREVIOUSLY DEPLOYED STENT WAS MADE. MULTIPLE WIRES WERE INTRODUCED. EVENTUALLY IT WAS POSSIBLE TO ADVANCE APEX BALLOONS IN SUCCESSION. A PREVIOUSLY SEEN FILLING DEFECT WAS NOW IMPROVED; HOWEVER THE PATIENT BEGAN EXHIBITING NEUROLOGICAL SIGNS OF A CEREBRAL EMBOLIC EVENT. ONE DAY FOLLOWING THE PROCEDURE THE PATIENT WAS STABLE BUT THE NEUROLOGICAL DEFICIT WAS STILL PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357352 GORE EMBOLIC FILTER NTE W.L. GORE & ASSOCIATES,INC 11469439

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other .014" WHISPER LS WIRE| .014" WHISPER SUPPORT WIRE| .018" TREASURE WIRE| .035" GLIDEWIRE WITH A SUPPORT CATHETER| .035" GUIDEWIRE | 1.5 MM X 20 MM APEX BALLOON| 3 MM X 20 MM APEX BALLOON| 5 FR SIMMONS 1 CATHETER FOR AORTOGRAM| 5 MM X 20 MM A-PEX BALLOON| 6 FR SHEATH| 6.5 FR CATHETER| 7 MM X 9 MM X 30 MM GORE SELF EXPANDING STENT| J-TIPPED | .014" WHISPER LS WIRE| 7 MM X 9 MM X 30 MM GORE SELF EXPANDING STENT| 3 MM X 20 MM APEX BALLOON| 6.5 FR CATHETER| .035" GUIDEWIRE| 1.5 MM X 20 MM APEX BALLOON| .014" WHISPER SUPPORT WIRE| .018" TREASURE WIRE| .035" GLIDEWIRE WITH A SUPPORT CATHETER| 5 MM X 20 MM A-PEX BALLOON| 6 FR SHEATH| J-TIPPED| 5 FR SIMMONS 1 CATHETER FOR AORTOGRAM