BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET

    MDR report key: 2894260 · Received December 27, 2012

    Report

    Report Number
    3002808486-2012-00037
    Event Type
    Injury
    Date Received
    December 27, 2012
    Report Date
    December 5, 2012
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K090140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNK. EXPIRATION DATE UNK AS LOT # IS UNK. IMPLANT DATE, EXPLANT DATE: UNK. DEVICE MANUFACTURE DATE: UNK AS LOT # IS NOT PROVIDED BY REPORTER. INVESTIGATION PERFORMED IS BASED ONLY ON THE DESCRIPTION OF THE EVENT, SINCE NEITHER DEVICE NOR IMAGES WERE AVAILABLE TO ASSIST THE INVESTIGATION. PT EXPERIENCED PAIN ONE MONTH AFTER FILTER PLACEMENT AND IT WAS NOTED BY OPEN SURGERY THAT THE FILTER PERFORATED AORTA AND RIGHT RENAL VEIN. HOWEVER, WITHOUT IMAGES, IT IS NOT POSSIBLE TO DETERMINE IF THE FILTER ACTUALLY DID PERFORATE AORTA AND RENAL VEIN OR IF A FILTER LEG PENETRATED INTO THE AORTA AND THE FILTER TILTED SO THE APEX HOOK WAS IN THE RENAL VEIN. THE INSTRUCTIONS FOR USE LIST DAMAGE TO THE VENA CAVA AND VENA CAVA PERFORATION AS POTENTIAL ADVERSE EVENTS, WHICH HAVE ALSO BEEN REPORTED IN THE PUBLICALLY AVAILABLE MEDICAL AND SCIENTIFIC LITERATURE. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. NOTHING FURTHER IS INITIATED SINCE THE DESCRIPTION DOES NOT INDICATE PRESENCE OF DEVICE FAILURE. HOWEVER, MONITORING OF SIMILAR REPORTS WILL CONTINUE.

    Description of Event or Problem · 1

    THE PT HAD AN IVF PLACED. APPROXIMATELY ONE MONTH FOLLOWING PLACEMENT, THE PT COMPLAINED OF PAIN. AN OPEN PROCEDURE WAS PERFORMED AND THE PHYSICIAN FOUND THE LEGS OF THE FILTER HAD PENETRATED THE IVC AND PUNCTURED THE RIGHT RENAL VEINS AND AORTA. THE PHYSICIAN REMOVED THE FILTER DURING THIS PROCEDURE. F/U PT IS CURRENTLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET DTK WILLIAM COOK EUROPE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention