BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 9460761 · Received December 12, 2019

    Report

    Report Number
    1820334-2019-03100
    Event Type
    Injury
    Date Received
    December 12, 2019
    Report Date
    December 12, 2019
    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 MDR WAS SUBMITTED BY WILLIAM COOK EUROPE UNDER MANUFACTURER REPORT REFERENCE NUMBER 3002808486-2019-01686. ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC. WITH THE SUBMISSION OF THIS INITIAL REPORT, COOK INC INFORMS THAT ALL FUTURE SUBMISSIONS REGARDING THIS COMPLAINT WILL BE HANDLED UNDER MANUFACTURER REPORT NUMBER REFERENCED IN THIS INITIAL MEDWATCH REPORT. INITIAL REPORTER OCCUPATION: NON-HEALTHCARE PROFESSIONAL. (B)(4). INVESTIGATION: INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: VENA CAVA PERFORATION, DEEP VEIN THROMBUS, MIGRATION, TILT, PAIN, ANXIETY, DEPRESSION, LIMITED MOBILITY. 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 PAIN, ANXIETY, DEPRESSION, LIMITED MOBILITY IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED AGAINST THE LOT. THE ASSOCIATED WORK ORDER WAS REVIEWED. NO RELATED/RELEVANT NOTES WERE DOCUMENTED. THE DEVICE IS MANUFACTURED AND INSPECTED ACCORDING TO CURRENT CONTROLS. 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 REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2011 VIA THE RIGHT JUGULAR VEIN DUE TO POST DEEP VEIN THROMBOSIS (DVT). TWO UNSUCCESSFUL PERCUTANEOUS FILTER RETRIEVAL ATTEMPTS WERE ALLEGED ON (B)(6) 2011 AND (B)(6) 2018. IT WAS ALLEGED, ANOTHER RETRIEVAL ATTEMPT WAS PERFORMED (B)(6) 2019; HOWEVER, IT IS UNKNOWN, AT THIS TIME, IF THE ATTEMPT WAS SUCCESSFUL. PATIENT IS ALLEGING DEVICE MIGRATION AND TILT, VENA CAVA PERFORATION AND DVT POST FILTER PLACEMENT. PATIENT NOTES AND FURTHER ALLEGES EXPERIENCING "CONTINUOUS PAIN IN MY UPPER TORSO AND BACK. CONSTANT ANXIETY OF POSSIBLE MIGRATION THAT COULD BE DEADLY". PATIENT FURTHER NOTES UNABLE TO DO HEAVY LIFTING DUE TO LEG ISSUES; DEPRESSION. PER THE (B)(6) 2011 IVC (INFERIOR VENA CAVA) FILTER PLACEMENT WITH THROMBOLYSIS AND THROMBECTOMY OF COMMON ILIAC/EXTERNAL ILIAC/COMMON FEMORAL VEIN LEFT: "IVC FILTER WITH SUCCESSFUL INFRARENAL PLACEMENT". PER THE (B)(6) 2011 UNSUCCESSFUL FILTER RETRIEVAL: "THE IVC FILTER WAS SNARED SUCCESSFULLY, BUT PT HAD PAIN WHEN ATTEMPT TO PULL FILTER OUT. FILTER LEFT IN PLACE DUE TO CONCERN ABOUT POSSIBLE IVC PERFORATION OR TEAR. NO COMPLICATIONS". PER THE (B)(6) 2018 UNSUCCESSFUL FILTER RETRIEVAL: "...BRIEF ATTEMPT WAS MADE TO RETRIEVE THE INDWELLING IVC FILTER, HOWEVER DUE TO ITS TILT, THE APEX WAS POSITIONED WITHIN THE RIGHT RENAL VEIN AND IT WAS UNABLE TO BE SAFELY CAPTURED..." ORIGINAL: 'IT IS ALLEGED THAT "[PT] RECEIVED A COOK GUNTHER TULIP FILTER ON (B)(6) 2011 AT (B)(6) HOSPITAL, (B)(6) BY IMPLANTING PHYSICIAN MITCHELL SILVER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253733 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC G33017 2680819 10827002330174

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening