BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDERX¿ EMBOLIC PROTECTION DEVICE

    MDR report key: 2001729 · Received February 25, 2011

    Report

    Report Number
    2183870-2011-00038
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    October 7, 2010
    Report Date
    February 2, 2011
    Manufacturer
    EV3 INC.
    Product Code
    NTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, AS A RESULT THE REVIEW OF THE MANUFACTURING RECORDS WAS NOT CONDUCTED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PERFORMING ATHERECTOMY ON A PROXIMAL LESION 10CM IN LENGTH. DUE TO THE HEAVY CALCIFICATION, A SPIDERX EMBOLIC PROTECTION DEVICE WAS PLACED AT THE POPLITEAL ARTERY. AFTER 8 PASSES, THERE WAS CONCERN FOR RUPTURE WITH STAINING IN THE PERIADVENTITIAL TISSUE. THEREFORE, THE ATHERECTOMY WAS ABORTED. A 4MM X 150MM PTA BALLOON WAS PLACED AND DILATED. THIS WAS LEFT IN SITU FOR 3 MINUTES WITH RESOLUTION OF THE ABNORMAL AREA. THEREFORE, THE ENTIRE SFA WAS TREATED WITH SELF-EXPANDING NITINOL STENTS (6MM AND 7MM) FROM ADDUCTOR CANAL TO THE ORIGIN OF THE SFA. THIS WAS POST-DILATED TO 6MM WITH EXCELLENT RESULT. THE SPIDERX EPD WAS RETRIEVED AND THERE WAS EVIDENCE OF DISTAL EMBOLIC DEBRIS IN THE PT AND PERONEAL. THEREFORE, WIRE ACCESS TO THE DISTAL PT WAS OBTAINED WITH PILOT WIRE AND QUICK-CROSS CATHETER. THE AREA OF EMBOLIC DEBRIS WAS ASPIRATED AND DIRECT SUCTION EMBOLECTOMY. THERE WAS STILL POOR FLOW. THEREFORE, THE SHEATH WAS PULLED BACK AND THE LEFT COMMON ILIAC WAS TREATED WITH TWO 8MM BALLOON EXPANDABLE STENTS FROM THE ORIGIN OF THE CIA TO THE ILIAC BIFURCATION. THE DESTINATION WAS THEN READVANCED TO THE LEFT COMMON FEMORAL. ANGIOGRAMS REVEALED EXCELLENT FLOW FROM THE ILIACS TO THE MID TIBIAL ARTERIES, HOWEVER, THERE WAS STILL POOR FLOW IN THE DISTAL PT. THEREFORE, THE QUICKCROSS WAS ADVANCED INTO THE DISTAL PT AGAIN AND THE AREA WAS ASPIRATED UNTIL ALL DEBRIS WAS REMOVED. THERE WAS A RESIDUAL STENOSIS AT THE TP TRUNK AND THIS WAS TREATED WITH ANOTHER ATHERECTOMY DEVICE UNTIL THE LESION WAS ADEQUATELY TREATED. COMPLETION ANGIOGRAMS WERE OBTAINED AND THERE WAS EXCELLENT IN LINE FLOW FROM THE ILIACS TO THE FOOT VIA THE TREATED SFA- > POPLITEAL- > PT. THE PROCEDURE WAS THEN TERMINATED. WITH COMPLETION OF THE PROCEDURE AND NO SIGNIFICANT RESIDUAL STENOSES NOR DISSECTIONS EVIDENT, THE DECISION WAS MADE TO USE FEMORAL CLOSURE DEVICE. PLEASE REFERENCE MDR 2183870-2010-00193 FOR THE TURBOHAWK USED IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDERX¿ EMBOLIC PROTECTION DEVICE TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE EV3 INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention QUICK CROSS CATHETER| TURBOHAWK| PILOT WIRE