BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 3001334 · Received March 6, 2013

    Report

    Report Number
    1820334-2013-00116
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    December 7, 2011
    Report Date
    February 7, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DTK
    PMA / PMN Number
    K043509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE - (UNKNOWN AS STILL UNDER INVESTIGATION). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT HAD A TULIP FILTER PLACED ON (B)(6) 2010 VIA THE JUGULAR APPROACH FOR A CLOT IN A LEG VEIN (PE/DVT). THIS WAS THE PATIENT'S FIRST PULMONARY EMBOLISM (PE) WITH NO CONTRAINDICATIONS FOR THE USE OF ANTICOAGULANT. THE PHYSICIAN ATTEMPTED TO REMOVE THE FILTER ABOUT 3 MONTHS FOLLOWING IMPLANT ((B)(6) 2010), BUT FAILED SECONDARY TO FILTER BEING TILTED. A SECOND UNSUCCESSFUL ATTEMPT WAS MADE BY ANOTHER PHYSICIAN TO REMOVE THE FILTER ((B)(6) 2011). THE PATIENT HAS A 2ND DOCUMENTED PE ON (B)(6) 2011 AND WAS PLACED ON AC. THE PATIENT TALKED TO OTHER PHYSICIANS WHO SUGGESTED THAT HE SHOULD HAVE HAD ANOTHER MANUFACTURER'S IVE FILTER, 12 OTHER PHYSICIANS INFORMED HIM THAT HE SHOULD NOT HAVE HAD A FILTER INITIALLY. THE PATIENT'S MAJOR COMPLAINT IS WITH THE PHYSICIAN WHO PLACED THE FILTER; BUT THE PATIENT ALSO INDICATED THAT THE TULIP FILTER PLACED IN HIM WAS DEFECTIVE SINCE IT DID NOT PREVENT HIS 2ND PE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95962 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention