BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 3954769 · Received July 18, 2014

    Report

    Report Number
    3002808486-2014-00033
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    July 2, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K090140
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CATALOG # UNK AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS CELECT FILTER. RPN AND LOT NUMBER WERE NOT PROVIDED, WHY DEVICE HISTORY RECORD CANNOT BE INVESTIGATED. HOWEVER, NOTHING INDICATES THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. NO DEVICE OR IMAGING HAVE BEEN AVAILABLE. CONSEQUENTLY, BASED ON VERY LIMITED INFORMATION IT IS DIFFICULT TO COMMENT ON THE ALLEGED FILTER PERFORATION AND FILTER FRACTURE. INSTRUCTIONS FOR USE LIST DAMAGE TO THE VENA CAVA, AND VENA CAVA PERFORATION AS POTENTIAL ADVERSE EVENTS. SUCH EVENTS HAVE ALSO BEEN REPORTED IN THE PUBLISHED MEDICAL AND SCIENTIFIC LITERATURE. THE EXACT ROOT CAUSE FOR THE FILTER FRACTURE CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO COMPLAINANT: THE COMPLAINT DEVICE WAS IMPLANTED FOR FOUR YEARS. THE PATIENT PRESENTED WITH ABDOMINAL PAIN. A CT SCAN SHOWED ONE OF THE FILTER LEGS WAS PENETRATING THE SUPERIOR MESENTERIC ARTERY CAUSING A PSEUDOANEURYSM. AS A RESULT, THE PATIENT HAD TO HAVE COILING OF THE SMA. THE FILTER WAS SUCCESSFULLY RETRIEVED WITH VASCULAR FORCEPS. ONE STRUT HAD FRACTURED AND WAS IN THE RIGHT VENTRICLE. THE PATIENT WAS ASYMPTOMATIC SO THE DECISION WAS MADE TO LEAVE THIS STRUT IN PLACE. PRIMARY STRUTS ALSO SHOWED CAVAL PENETRATION. PATIENT OUTCOME: THE PATIENT WAS ASYMPTOMATIC SO THE DECISION WAS MADE TO LEAVE THIS STRUT IN PLACE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423114 UNK DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention