BEUDAMED
    FDA Adverse Event Other Summary report: N

    COOK CELECT FEMORAL VENA CAVA FILTER SET

    MDR report key: 3022613 · Received March 22, 2013

    Report

    Report Number
    3002808486-2013-00005
    Event Type
    Other
    Date Received
    March 22, 2013
    Report Date
    March 1, 2013
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K061815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    SUMMARY OF CLAIMANT'S ATTORNEY'S ALLEGATIONS: IT IS ALLEGED THAT ON (B)(6) 2010 THE PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT. ON (B)(6) 2010, THE PATIENT UNDERWENT PROPHYLACTIC PLACEMENT OF A COOK CELECT INFERIOR VENA CAVA. ON (B)(6) 2011, THE PHYSICIANS ATTEMPTED TO RETRIEVE THE IVC FILTER FROM THE PATIENT'S INFERIOR VENA CAVA. DUE TO MIGRATION OF THE FILTER, THE PHYSICIAN'S WERE NOT ABLE TO RETRIEVE THE FILTER. ON (B)(6) 2011, THE PATIENT UNDERWENT AN IR INTERVENTIONAL VASCULAR PROCEDURE AT THE (B)(6) MEDICAL CENTER. DURING THE PROCEDURE, THE PHYSICIANS DETECTED SIGNIFICANT THROMBUS WITHIN THE INFERIOR VENA CAVA AND PROXIMAL RIGHT COMMON ILIAC VEIN. AS A RESULT OF THE BLOOD CLOTS, THE PHYSICIANS WERE NOT ABLE TO RETRIEVE THE FILTER. IN MID (B)(6) 2011, THE PATIENT BEGAN EXPERIENCING PAIN AND DISCOMFORT IN THE AREA OF HER ABDOMEN. ON (B)(6) 2011, THE PATIENT WAS EXAMINED BY HER FAMILY PHYSICIAN. THE PATIENT'S PHYSICIAN ORDERED A CT OF THE PATIENT'S ABDOMEN. CT FINDINGS REFLECTED THAT THE IVC FILTER PRONGS HAD EXTENDED BEYOND THE PATIENT'S INFERIOR VENA CAVA AND HAD INVADED HER DUODENUM. ON (B)(6) 2011, THE PATIENT WAS TAKEN TO THE (B)(6) EMERGENCY DEPARTMENT. ON (B)(6) 2011, THE PATIENT UNDERWENT SURGERY TO REMOVE THE FILTER AND TO REPAIR THE PERFORATED DUODENUM. IT IS ALLEGED THAT THE PATIENT SUFFERED TEMPORARY AND PERMANENT PHYSICAL INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119750 COOK CELECT FEMORAL VENA CAVA FILTER SET UNKNOWN DTK WILLIAM COOK EUROPE E2453137

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention