BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 5491754 · Received March 10, 2016

    Report

    Report Number
    3002808486-2016-00099
    Event Type
    Malfunction
    Date Received
    March 10, 2016
    Report Date
    February 22, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. SUMMARY OF INVESTIGATIONAL FINDINGS: THE REPORTED CHANGED FILTER POSITION CANNOT BE CONFIRMED, BUT A MILD RIGHTWARD TILT. TWO SECONDARY LEGS EITHER PERFORATE THROUGH LEFT LATERAL IVC WALL OR EXTEND INTO A LUMBAR OR ACCESSORY RENAL VEIN. VERY LIMITED INFORMATION IS PROVIDED AND THE FILTER IMPLANT PERIOD IS UNKNOWN. CONSEQUENTLY, IT CANNOT BE DETERMINED IF THE LEGS PERFORATED DURING IMPLANTATION LIFE, BUT FILTER PERFORATION OF THE VENA CAVA WALL IS A KNOWN RISK REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. ALSO, PUBLISHED SCIENTIFIC LITERATURE DESCRIBES THAT MANIPULATION IN THE AREA OF FILTER PLACEMENT COULD CONTRIBUTE TO CHANGES TO THE FILTER CONFIGURATION AND PLACEMENT THEREBY POTENTIALLY INITIATE PERFORATION OF THE VENA CAVA WALL. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE AND MAY OCCUR DURING PLACEMENT OR IMPLANTING PERIOD. LOT# AND RPN ARE UNKNOWN, BUT THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM VIA PLACEMENT IN THE VENA CAVA. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. INVESTIGATION IS STILL IN PROGRESS. (B)(4). SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815, K073374, K090140, K112119, K121057 OR K121629. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: FILTER CHANGED POSITIONS TO A MORE CAUDAL POSITION, AS WELL AS THE STRUTS BEING POSSIBLY EXTRA CAVAL. PATIENT OUTCOME: THE FILTER WAS ABLE TO BE RETRIEVED DUE TO THE PHYSICIANS SKILL SET AND THANKFULLY NO ISSUES WERE NOTED BY THE PATIENTS POST SUCCESSFUL RETRIEVAL.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: FILTER CHANGED POSITIONS TO A MORE CAUDAL POSITION, AS WELL AS THE STRUTS BEING POSSIBLY EXTRA CAVAL. PATIENT OUTCOME: THE FILTER WAS ABLE TO BE RETRIEVED DUE TO THE PHYSICIANS SKILL SET AND THANKFULLY NO ISSUES WERE NOTED BY THE PATIENTS POST SUCCESSFUL RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150314 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other