BEUDAMED
    FDA Adverse Event Death Summary report: N

    G2 FILTER SYSTEM - JUGULAR

    MDR report key: 8751409 · Received July 1, 2019

    Report

    Report Number
    2020394-2019-01346
    Event Type
    Death
    Date Received
    July 1, 2019
    Date of Event
    April 2, 2007
    Report Date
    October 19, 2020
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K052578
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS, AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. APPROXIMATELY, EIGHT MONTHS OF POST-DEPLOYMENT, FILTER REMOVAL PROCEDURE WAS PERFORMED. RIGHT INTERNAL JUGULAR VEIN ACCESS WAS OBTAINED WITH 5 FRENCH MICROCATHETER. A VENOGRAM WAS PERFORMED DEMONSTRATING NARROWING OF THE INFERIOR VENA CAVA AT THE LEVEL OF THE SUPRARENAL FILTER WITH NO EVIDENCE OF THROMBOSIS. A SINGLE LEG FROM THE G2 FILTER WAS ALSO NOTED TO BE FRACTURED. VENOUS ACCESS WAS DILATED, AND A 10 FRENCH SHEATH ADVANCED TO THE LEVEL OF THE INFERIOR VENA CAVA FILTER. FILTER WAS UNABLE TO CAPTURE WITH CONE. THE PROCEDURE WAS TERMINATED. A MALFUNCTION OF THE CONE WAS NOTED. EVENTUALLY, AFTER ONE MONTH, THE FILTER REMOVAL PROCEDURE WAS PERFORMED AGAIN. ULTRASOUND-GUIDED ACCESS TO THE RIGHT INTERNAL JUGULAR VEIN WAS OBTAINED AND 5FR VASCULAR SHEATH WAS PLACED. A 0.035 BENSON WIRE WAS ADVANCED TO THE INFERIOR VENA CAVA. OVER THE WIRE, A 5FR FLUSH CATHETER WAS PLACED AT THE BIFURCATION OF THE INFERIOR VENA CAVA AND CAVOGRAPHY CARRIED OUT. A 0.038 GLIDEWIRE WAS USED TO SELECT THE LEFT ILIAC VEIN AND CATHETER WAS EXCHANGED FOR A 5FR DAVIS CATHETER. LEFT ILIAC VENOGRAM WAS THEN PERFORMED. SERIAL DILATATION OF THE TRACT WAS PERFORMED UP TO 10FR WITH 10FR RECOVERY SHEATH PLACED IN THE INFERIOR VENA CAVA OVER A 0.035 AMPLATZ WIRE. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO GRASP THE FILTER USING BI-PLANE FLUOROSCOPY AND REPOSITIONING VIA THE RECOVERY SHEATH. THEN MULTIPLE ATTEMPTS WERE MADE WITH HOT FORCEPS TO GRASP THE FILTER WHICH WAS ALSO UNSUCCESSFUL. THEN A 6FR VASCULAR SHEATH WAS PLACED AND AN 0.035 WIRE ADVANCED INTO THE INFERIOR VENA CAVA THROUGH THE FILTER. OVER THE WIRE, AN 8 MM CONQUEST BALLOON WAS ADVANCED INTO THE FILTER AND INFLATED WITHOUT DISLODGING OR LOOSENING THE INFERIOR VENA CAVA FILTER. AT THIS TIME THROUGH AND THROUGH ACCESS WAS OBTAINED BETWEEN THE RIGHT GROIN AND RIGHT NECK VENOTOMY SITE WITH A BENTSON WIRE AND UNSUCCESSFUL ATTEMPTS WERE MADE TO GRASP THE FILTER USING THE 10FR FILTER RECOVERY DEVICE. THE PROCEDURE WAS DISCONTINUED. COMPUTED TOMOGRAPHY SCAN WAS REVEALED NO RETROPERITONEAL HEMATOMA. THE STABLE POSITION OF SUPRARENAL INFERIOR VENA CAVA FILTER WITH THE SUPERIOR TIP AT INFERIOR ENDPLATE OF T12, UNCHANGED APPEARANCE OF A SINGLE FRACTURED LEG. AROUND FOUR YEARS AND FOUR MONTHS, THE FILTER REMOVAL PROCEDURE WAS PERFORMED AGAIN. ACCESS TO THE RIGHT COMMON FEMORAL VEIN WAS OBTAINED UNDER DIRECT ULTRASOUND GUIDANCE USING A MICROPUNCTURE NEEDLE. 5 FRENCH VASCULAR SHEATH WAS PLACED. A 0.035 GLIDEWIRE WAS ADVANCED THROUGH THE OMNIFLUSH CATHETER AND USED TO CROSS THE INFERIOR VENA CAVA BIFURCATION. THE 0.035 GLIDEWIRE WAS REINSERTED USED TO UNIFORM OMNIFLUSH CATHETER. IT WAS THEN POSITIONED IN THE INFERIOR VENA CAVA JUST INFERIOR TO THE INDWELLING FILTER. MYOCARDIAL BIOPSY FORCEPS WERE PLACED THROUGH THE SHEATH AND ADDITIONAL DISSECTION OF THE FILTER WAS PERFORMED. THE AMPLATZ WIRE WAS THEN INTRODUCED THROUGH THE RIGHT FEMORAL SHEATH AND IT WAS UPSIZED FOR AN 8 FRENCH SHEATH. THE MYOCARDIAL BIOPSY FORCEPS WERE REMOVED FROM THE JUGULAR SHEATH AND INTRODUCER THROUGH THE FEMORAL SHEATH IN ORDER TO DISSECT THE LEGS OF THE FILTER FROM THE CAVAL WALL. A 25 MM GOOSENECK SNARE WAS INTRODUCED ALONGSIDE THE GLIDEWIRE AND ADVANCED PAST THE POSTERIOR ASPECT OF THE FILTER. THE GLIDEWIRE WAS SNARED BELOW THE FILTER IN AND PULLED THROUGH THE SHEATH SO THAT THE WIRE FORMED AN IN-SITU SNARE. THE FILTER WAS GRASPED FROM BELOW WITH THE MYOCARDIAL BIOPSY FORCEPS IN ORDER TO STRAIGHTEN IT WHILE IT WAS CAPTURED FROM ABOVE WITH A 14 FRENCH SHEATH. THE CATHETERS AND SHEATH WERE REMOVED. POST FILTER REMOVAL CAVOGRAM SHOWS COMPLETE REMOVAL OF THE INFERIOR VENA CAVA FILTER WITH NO RESIDUAL FOREIGN BODY. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR FILTER LIMB DETACHMENT AND RETRIEVAL DIFFICULTIES, HOWEVER THE INVESTIGATION IS INCONCLUSIVE FOR PERFORATION OF THE INFERIOR VENA CAVA (IVC) AND FILTER TILT. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTS (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, AND UNIT LABEL) SHOWED THAT THE PRODUCT LABELING IS ADEQUATE. (EXPIRY DATE: 02/2007), (DEVICE: 4001).

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER TILTED, DETACHED AND STRUTS PERFORATED INTO THE ORGANS. THE DEVICE AND DETACHED STRUTS WERE REMOVED PERCUTANEOUSLY AFTER TWO ATTEMPTED BUT UNSUCCESSFUL REMOVAL PROCEDURE. THE PATIENT REPORTEDLY EXPIRED.

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED. IMAGES AND MEDICAL RECORDS WERE NOT PROVIDED. THE INVESTIGATION IS INCONCLUSIVE AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE FILTER. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. AT THIS TIME, IT IS UNKNOWN THE RELATIONSHIP BETWEEN THE FILTER AND THE REPORTED DEATH. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTS (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, AND UNIT LABEL) SHOWED THAT THE PRODUCT LABELING IS ADEQUATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOME TIME POST VENA CAVA FILTER DEPLOYMENT (DATE NOT PROVIDED), THE PATIENT EXPIRED. THERE WAS NO SPECIFIC DEVICE MALFUNCTION REPORTED THAT MAY OR MAY NOT HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S DEATH. THE CAUSE OF THE PATIENT¿S DEATH WAS NOT PROVIDED. NO OTHER PERTINENT PATIENT, DEVICE OR MEDICAL INFORMATION WAS PROVIDED LEADING UP TO OR SURROUNDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543450 G2 FILTER SYSTEM - JUGULAR VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFQA2994

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Death