BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNADO PLATINUM EMBOLIZATION MICROCOIL

    MDR report key: 2072625 · Received April 20, 2011

    Report

    Report Number
    1820334-2011-00188
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    COOK INC.
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION: UNKNOWN AS LOT IS UNKNOWN. (B)(4) DEVICE DISLODGING AND MOVING ARE LABELED IN THE IFU. INVESTIGATION EVAL.: NO PRODUCT OR IMAGES WERE PROVIDED TO ASSIST IN THIS INVESTIGATION. QUALITY CONTROL INSPECTS THE DIAMETER OF FIRST AND LAST CURL. THE IFU STATES: "POSITIONING OF EMBOLIZATION COILS SHOULD BE DONE WITH PARTICULAR CARE. COILS SHOULD NOT BE LEFT TOO CLOSE TO THE INLETS OF ARTERIES AND SHOULD BE INTERMESHED WITH PREVIOUSLY PLACED COILS IF POSSIBLE. A MINIMAL BUT SUFFICIENT BLOOD FLOW SHOULD REMAIN TO HOLD THE COILS AGAINST THE PREVIOUSLY PLACED COILS UNTIL A SOLID CLOT ENSURES PERMANENT FIXATION. THE PURPOSE OF THESE SUGGESTIONS IS TO MINIMIZE THE POSSIBLY OF LOOSE COILS BECOMING DISLODGED AND OBSTRUCTING A NORMAL AND ESSENTIAL ARTERIAL CHANNEL." THE COMPLAINT STATES THE MWCE-18S-8/4-TORNADO COILS WERE USED. THIS TYPE OF COIL CONTAINS A 8 MM PROXIMAL END DIAMETER AND 4 MM DISTAL END DIAMETER. SINCE THE COILS WERE PLACED IN A 9 MM DIAMETER VESSEL, IT IS POSSIBLE THAT THE COILS WERE SLIGHTLY UNDERSIZED. ADDITIONALLY, ACCORDING TO THE BOOK TRANSCATHETER EMBOLIZATION AND THERAPY - TECHNIQUES IN IR SERIES (DAVID KESSEL AND CHARLES RAY - EDITORS): "MASSIVE RENAL AVFS CAN BE PROBLEMATIC TO TREAT DUE TO THE SIZE OF THE AV COMMUNICATION AND THE TORRENTIAL FLOW. THERE IS A SIGNIFICANT RISK OF LOSS OF THE EMBOLIC DEVICE THROUGH THE FISTULA AND INTO THE PULMONARY CIRCULATION. A COMBINATION OF INFLOW AND OUTFLOW OCCLUSION BALLOON CONTROL, OVERSIZED COILS, VASCULAR PLUGS, AND IN SOME CASES LIQUID AGENTS (NBCA, ONYX) MAY BE NECESSARY TO COMPLETELY CLOSE THESE LESIONS." WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL. QUALITY ENGINEERING RISK ASSESSMENT WAS NOT UPDATED IN RESPONSE TO THIS COMPLAINT. THE ADDITION OF THIS COMPLAINT WOULD NOT INCREASE THE OCCURRENCE RATE OR RISK PRIORITY NUMBER. THEREFORE, THE CONCLUSION OF QERA, THAT NO FURTHER MITIGATING ACTION IS NECESSARY AT THIS TIME, IS STILL VALID.

    Description of Event or Problem · 1

    COIL EMBOLIZATION OF RENAL ARTERIO-VENOUS FISTULA FOR A (B)(6) MALE PT WAS PERFORMED IN THE MIDDLE OF THE DAY OF (B)(6) 2011 AND THE EVENT OCCURRED AROUND 3 AM ON (B)(6) 2011. INGUINAL AREA WAS PUNCTURED AND DEVICES WERE INSERTED FROM VEIN, HOWEVER, THEY FLOWED TO INFERIOR VENA CAVA SINCE FLOW CONTROL WAS DIFFICULT. THEN THE DEVICES WERE INSERTED FROM ARTERY. ANOTHER MANUFACTURERS CATHETER (20MM SELECON) WAS INSERTED INTO 9MM RIGHT RENAL ARTERY TO CONTROL BLOOD FLOW, BUT FLOW WAS NOT UNCONTROLLABLE. UNDER THE CONDITION, ANOTHER MANUFACTURER'S COILS (BOSTON SCIENTIFIC GDC 360 DEGREE COILS AND GDC 3D COILS) WERE USED FOR FRAMING WITH TWO MICROCATHETERS, BUT THE COILS WERE NOT FORMED ADEQUATELY. FLAMING WAS COMPLETED AFTER SEVERAL ATTEMPTS. THE OTHER MANUFACTURER'S COILS (GDC 2D COILS) AND THREE COOK TORNADO COILS WERE USED FOR FILLING. AFTER THE TORNADO COILS WERE PLACED, GDC COILS AND TWO TORNADO COILS USED FOR FILLING FLOWED TO PERIPHERAL PULMONARY ARTERY DUE TO BLOOD FLOW. MOREOVER THREE OTHER GDC COILS DRIFTED IN INFERIOR VENA CAVA. ONE OTHER TORNADO COIL USED FOR FILLING WAS STABLE IN TARGET POSITION. TWO TORNADO COILS FLOWED TO PERIPHERAL PULMONARY ARTERY WERE NOT RETRIEVED SINCE THE PHYSICIAN THOUGHT IT WOULD BE DIFFICULT TO RETRIEVE IT. ONE OF THREE GDC. COILS DRIFTED IN INFERIOR VENA CAVA WAS FOUND TO BE UNRAVELED WHEN IT WAS RETRIEVED WITH A SNARE. MOREOVER ANOTHER COILS USED FOR FRAMING WERE ALSO FLOWED TO INFERIOR VENA CAVA DURING RETRIEVAL OF COILS, AND THE COILS WERE CAUGHT BY ANOTHER MANUFACTURER'S FILTER (TORAY IVC FILTER) PREVIOUSLY PLACED FOR PROTECTION. THE COILS CAUGHT BY THE FILTER WERE RETRIEVED WITH THE SNARE. THE PHYSICIAN THOUGHT COILS STILL PLACED IN TARGET POSITION MIGHT FLOW IF A BALLOON USED FOR FLOW CONTROL WAS DEFLATED, AND THE PROCEDURE WAS CONVERTED TO SURGICAL OPERATION AND KIDNEY WAS EXTIRPATED (REMOVED). IT IS UNK THE PT'S CONDITION AFTER THE PROCEDURE SINCE IT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNADO PLATINUM EMBOLIZATION MICROCOIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention