BEUDAMED
    FDA Adverse Event Death Summary report: N

    GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH

    MDR report key: 6265905 · Received January 20, 2017

    Report

    Report Number
    3002808486-2017-00024
    Event Type
    Death
    Date Received
    January 20, 2017
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. CATALOG # IGTCFS-65-JP-JUG-TULIP. SIMILAR TO DEVICE UNDER 510/(K) K090140. MFR DATE UNKNOWN. SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION FOUND RETURNED FILTER MANUFACTURED ACCORDING TO SPECIFICATIONS. GIVEN REPORTED HISTORY OF THROMBOTIC EVENTS THROUGHOUT THE BODY, VENOUS THROMBOEMBOLISM FROM UPPER EXTREMITIES IS POSSIBLE. ADDITIONALLY, THE PATIENT WAS KNOWN TO HAVE PULMONARY EMBOLI ALREADY AND THEN TAKEN OFF ANTICOAGULATION. ALTHOUGH PULMONARY EMBOLI WERE SAID TO BE SUBCLINICAL, THE RENAL VEIN REFLUX DURING FILTER PLACEMENT SUGGESTS OTHERWISE. THE ALREADY PRESENT PULMONARY EMBOLI MAY HAVE ENLARGED. IN THIS CASE RECURRENT PULMONARY EMBOLISM THROUGH THE TULIP FILTER IS HIGHLY UNLIKELY. THESE PULMONARY EMBOLI WERE MASSIVE AND HAD THEY ORIGINATED FROM BELOW, IN, OR ABOVE OF THE FILTER, THROMBUS SHOULD HAVE BEEN IDENTIFIED IN THE FILTER, SHEATH, AND INFERIOR VENA CAVA. ALTERNATIVE EXPLANATIONS ARE MORE LIKELY. GIVEN THE REPORTED HISTORY OF THROMBOTIC EVENTS THROUGHOUT THE BODY, VENOUS THROMBOEMBOLISM FROM THE UPPER EXTREMITIES IS POSSIBLE. PACKAGE INSERT; POTENTIAL ADVERSE EVENTS: ACUTE OR RECURRENT PULMONARY EMBOLISM. BASED ON THE LIMITED INFORMATION PROVIDED THE EXACT REASON FOR THIS INCIDENT CANNOT BE DETERMINED, AND CONSEQUENTLY IT IS UNKNOWN, IF IT WAS RELATED TO THE FILTER PERFORMANCE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: (B)(6) 2014:THE COMPLAINT FILTER WAS PLACED IN THE PATIENT BY RIGHT JUGULAR APPROACH. ON (B)(6) 2014 :SURGICAL OPERATION WAS PERFORMED BY ORTHOPEDIC SURGERY DEPARTMENT. ON (B)(6) 2014, PULMONARY EMBOLISM WAS CONFIRMED. IN ADDITION, BLOOD CLOTS SPREAD THROUGHOUT THE ENTIRE BODY OF THE PATIENT. AFTER THE FILTER WAS RETRIEVED OUT OF THE BODY, THE BLOOD CLOTS WERE REMOVED UNDER PCPS. ADDITIONAL INFORMATION RECEIVED 18SEP2016: PE AND DVT OCCURRED TO THE PATIENT DUE TO TIBIA BONE FRACTURE. HOWEVER, ALTHOUGH CAPROCIN(HEPARIN CALCIUM) AND HEPARIN WERE ADMINISTERED AT ANOTHER FACILITY, THE CONDITION OF THE PATIENT DID NOT IMPROVE. THEREFORE, THE PATIENT WAS TRANSFERRED TO THIS FACILITY SO THAT HE COULD TAKE IVC FILTER PLACEMENT AND SURGICAL OPERATION AT THE ORTHOPEDIC DEPARTMENT. ON (B)(6) 2014, IVC FILTER PLACEMENT WAS PERFORMED. ACCORDING TO THE PATIENT'S EVALUATION AT ANOTHER HOSPITAL, A LOT OF BLOOD CLOTS IN RIGHT SFV AND ASYMPTOMATIC PULMONARY EMBOLISM HAD BEEN OBSERVED TO THE PATIENT BEFORE HE WAS TRANSFERRED TO THIS FACILITY. HOWEVER, AT THIS FACILITY, WITHOUT EVALUATING THE CONDITION OF THE BLOOD CLOTS OF THE PATIENT, IVC FILTER PLACEMENT WAS PERFORMED. AFTER THE FILTER WAS PLACED WITHOUT PROBLEMS, SURGICAL OPERATION WAS PERFORMED AT THE ORTHOPEDIC DEPARTMENT. OWING TO THE COMPLICATION AFTER THE SURGERY (HEMORRHAGIC SHOCK), ADMINISTRATION OF THE ANTICOAGULANT WAS DISCONTINUED THEN. THE CONDITION OF THE PATIENT IMPROVED. HOWEVER, WHEN THE PATIENT SIT UP SO AS TO CONDUCT REHABILITATION ON (B)(6) 2014, THE PATIENT COMPLAINED CHEST PAIN AND BECAME UNCONSCIOUS. SO AS TO USE PCPS AGAINST THIS, THE FILTER WAS RETRIEVED OUT OF THE BODY FIRST. THE FILTER COULD BE RETRIEVED WITHOUT RESISTANCE. THEN, PCPS WAS PLACED IN THE PATIENT AND HE SURVIVED FOR A WHILE WITH IT, BUT BEFORE DAWN, THE PATIENT DIED. AFTER THE DEMISE, AUTOPSY WAS PERFORMED AND THE CONDITION OF THE REGION WHERE THE FILTER HAD BEEN PLACED WAS CHECKED, CONFIRMING NO BLOOD CLOTS IN/AROUND IVC. HOWEVER, FRESH THROMBI WERE OBSERVED IN BOTH OF THE RIGHT AND LEFT LUNG, WHICH WAS PRESUMED TO BE THE CAUSE OF THE DEATH BY SHOCK. WHETHER BLOOD CLOTS WERE IN THE LOWER LIMB OR UPPER LIMB WAS NOT EVALUATED. NO ADHERENCE OF THE BLOOD CLOTS WAS ON THE RETRIEVED FILTER. THE INNER LUMEN OF THE SHEATH USED FOR RETRIEVAL OF THE FILTER WAS ALSO CHECKED, BUT NO THROMBI WERE CONFIRMED EITHER. IT IS GUESSED THAT THE BLOOD CLOTS FORMED IN THE LOWER LIMB PASSED THROUGH THE FILTER WITHOUT BEING TRAPPED BY IT SOMEHOW AND REACHED THE LUNG. PATIENT OUTCOME: THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50119 GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death