BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT FEMORAL VENA CAVA FILTER SET

    MDR report key: 3221414 · Received July 5, 2013

    Report

    Report Number
    3002808486-2013-00016
    Event Type
    Injury
    Date Received
    July 5, 2013
    Date of Event
    June 13, 2011
    Report Date
    June 28, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K073374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT NUMBER: (B)(4). EXPIRATION DATE, UNK AS LOT# IS UNK. EXACT EXPLANT DATE IS UNK BUT IT WAS ON OR ABOUT (B)(6) 2011. THE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ACCORDING TO ATTORNEY'S COMPLAINT: A COOK CELECT IVC FILTER WAS POSITIONED AND DEPLOYED AT THE LEVEL OF THE L2 VERTEBRAL BODY. COMPLETION VENA CAVAGRAM SHOWED FILTER IN GOOD POSITION. THERE WERE NO COMPLICATIONS. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2011, THE PT WAS ADMITTED TO THE EMERGENCY DEPARTMENT OF (B)(6) HOSPITAL IN COMPLAINING OF ABDOMINAL AND LOWER BACK PAIN. THE PT HAD A CT SCAN OF THE ABDOMEN AND PELVIS WHICH ALLEGEDLY SHOWED THAT THE VENA CAVA FILTER WAS TILTED SUCH THAT ITS SUPERIOR MARGIN WAS AGAINST THE LEFT LATERAL WALL OF THE INFERIOR VENA CAVA. INFERIORLY THE LIMBS HAD EXTENDED THROUGH THE INFERIOR VENA CAVA AND INTO THE RIGHT KNEE KIDNEY CAUSING SEVERE HYDRONEPHROSIS. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2011, THE PT'S PHYSICIANS ATTEMPTED TO USE AN ULTRASOUND-GUIDED EXPLANT; HOWEVER, DUE TO COMPLICATIONS THIS WAS ABORTED. ACCORDING TO ATTORNEY'S COMPLAINT THE PT THEN UNDERWENT AN OPEN EXTRACTION OF THE COOK FILTER WITH PATCH ANGIOPLASTY OF THE IVC AND DISSECTION AROUND THE RENAL PELVIS. PT OUTCOME: ACCORDING TO ATTORNEY'S COMPLAINT: ALLEGEDLY EXTENSIVE MEDICAL CARE AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308171 COOK CELECT FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E2278787

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Life Threatening| R