BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 10587724 · Received September 25, 2020

    Report

    Report Number
    1820334-2020-01758
    Event Type
    Injury
    Date Received
    September 25, 2020
    Report Date
    September 25, 2020
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330174
    PMA / PMN Number
    K072240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PREVIOUS MEDWATCH REPORT WAS SUBMITTED BY WILLIAM COOK EUROPE UNDER MANUFACTURER REPORT REFERENCE# 3002808486-2019-01622. ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC. WITH THE SUBMISSION OF THIS INITIAL MEDWATCH REPORT, COOK INC. INFORMS THAT ALL FUTURE SUBMISSIONS REGARDING THIS COMPLAINT WILL BE HANDLED UNDER THE MANUFACTURER REPORT REFERENCE #. OCCUPATION: NON-HEALTHCARE PROFESSIONAL INVESTIGATION: THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: ORGAN-MESENTERIC PERFORATION, DEEP VEIN THROMBOSIS (DVT), MIGRATION, TILT, SHORTNESS OF BREATH (SOB), ABDOMINAL PAIN, POOR LEG CIRCULATION, ANXIETY/MENTAL ANGUISH, STRESS, LIMITED MOBILITY. INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. FILTER INTERACTS WITH IVC WALL, E.G. PENETRATION/PERFORATION/EMBEDMENT. THIS MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. POTENTIAL CAUSES MAY INCLUDE IMPROPER DEPLOYMENT; AND (OR) EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IN-SITU FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER). POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: TRAUMA TO ADJACENT STRUCTURES, VASCULAR TRAUMA, VENA CAVA PERFORATION, VENA CAVA PENETRATION. IVC OCCLUSION/ THROMBOSIS, NEW DVT, IVC STENOSIS AS A REPORTED COMPLICATION, IS A KNOWN RISK IN RELATION TO FILTER IMPLANT AND IS WELL DOCUMENTED IN THE CLINICAL LITERATURE AND IN CLINICAL PRACTICE GUIDELINES. THIS IS SUPPORTED BY THE CLINICAL EVIDENCE REPORT ESTABLISHED TO ASSESS AVAILABLE CLINICAL DATA TO IDENTIFY AND EVALUATE THE CLINICAL SAFETY AND PERFORMANCE OF THE COOK VENA CAVA FILTERS. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: VENA CAVA OCCLUSION OR THROMBOSIS, VENA CAVA STENOSIS, DEEP VEIN THROMBOSIS. FILTER OR FILTER FRAGMENT MIGRATION AND (OR) EMBOLIZATION (E.G., MOVEMENT TO THE HEART OR LUNGS) HAS BEEN REPORTED. FILTER OR FILTER FRAGMENT MOVEMENT HAS OCCURRED IN BOTH THE CRANIAL AND CAUDAL DIRECTION AND MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. POTENTIAL CAUSES MAY INCLUDE FILTER PLACEMENT IN IVCS WITH DIAMETERS SMALLER OR LARGER THAN THOSE SPECIFIED IN THESE INSTRUCTIONS FOR USE; IMPROPER DEPLOYMENT; DEPLOYMENT INTO THROMBUS; DISLODGEMENT DUE TO LARGE THROMBUS BURDENS; AND (OR) EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IN SITU FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER). POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: FILTER MIGRATION, TRAUMA TO ADJACENT STRUCTURES. FILTER TILT HAS BEEN REPORTED. POTENTIAL CAUSES MAY INCLUDE FILTER PLACEMENT IN IVCS WITH DIAMETERS LARGER THAN THOSE SPECIFIED IN THESE INSTRUCTIONS FOR USE; IMPROPER DEPLOYMENT; MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER); AND (OR) A FAILED RETRIEVAL ATTEMPT. EXCESSIVE FILTER TILT MAY CONTRIBUTE TO DIFFICULT OR FAILED RETRIEVAL; VENA CAVA WALL PENETRATION/PERFORATION; AND (OR) RESULT IN LOSS OF FILTER EFFICIENCY. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: UNACCEPTABLE FILTER TILT. UNKNOWN IF THE REPORTED SHORTNESS OF BREATH (SOB), ABDOMINAL PAIN, POOR LEG CIRCULATION, ANXIETY/MENTAL ANGUISH, STRESS, AND LIMITED MOBILITY ARE DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. (B)(4) DEVICES IN LOT. NO RELEVANT NOTES ON WORK ORDER. THE PRODUCT IS MANUFACTURED AND INSPECTED ACCORDING TO SPECIFICATIONS. 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 (PE) VIA PLACEMENT IN THE VENA CAVA. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2010 VIA THE LEFT INTERNAL JUGULAR VEIN DUE TO PRIOR DEEP VEIN THROMBOSIS (DVT), UNRELIABLE WITH TAKING MEDS DUE TO SCHIZOPHRENIA AND NONCOMPLIANCE. THE PATIENT ALLEGES MIGRATION, TILT, ORGAN-MESENTERIC PERFORATION, AND DEEP VEIN THROMBOSES. THE PATIENT FURTHER ALLEGES SHORTNESS OF BREATH, ABDOMINAL PAIN, POOR CIRCULATION TO LEGS, ANXIETY, MENTAL ANGUISH, STRESS, AND LIMITED MOBILITY. (B)(6) 2017, PER A REPORT FROM COMPUTED TOMOGRAPHY; ¿FINDINGS: IVC FILTER APPEARS FULLY EXPANDED AND IS LOW-LYING IN POSITION. THE APEX OF THE FILTER IS LOCATED 2.6CM CAUDAL TO THE LOWEST RENAL VEIN (ON THE RIGHT). THE FILTER IS TILTED TO THE RIGHT, SHOWING THE APEX LOCATED WITHIN THE VESSEL LUMEN 5MM TO THE RIGHT OF THE CENTERLINE, NOT IMPACTING THE WALL. THE ANTERIOR ANCHORING STRUT OF THE FILTER EXTENDS INTO THE ORIGIN OF THE RIGHT COMMON ILIAC VEIN WHICH ARISES ANTERIORLY. THE DISTAL END OF THE POSTERIOR STRUT APPEARS TO PERFORATE THE POSTERIOR VESSEL WALL BY UP TO 4MM, AND CONTACTS THE ANTEROLATERAL MARGIN OF THE L4-L5 DISC.¿ ORIGINAL: 'IT IS ALLEGED THAT "[PT] RECEIVED A COOK GUNTHER TULIP FILTER ON (B)(6) 2010 AT (B)(6) HOSPITAL, BY IMPLANTING PHYSICIAN (B)(6)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050770 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC G33017 2425161 10827002330174

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening