BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G2 EXPRESS FILTER SYSTEM - FEMORAL

    MDR report key: 10668624 · Received October 13, 2020

    Report

    Report Number
    2020394-2020-05953
    Event Type
    Injury
    Date Received
    October 13, 2020
    Date of Event
    May 1, 2009
    Report Date
    November 17, 2020
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K080668
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: 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 THREE MONTHS LATER, FILTER REMOVAL PROCEDURE WAS PERFORMED. RIGHT INTERNAL JUGULAR PUNCTURE WAS PERFORMED WITH MICROPUNCTURE TECHNIQUE AND ULTRASOUND GUIDANCE. A 0.018 WIRE WAS ADVANCED FOLLOWED BY ¾ DILATOR. A 0.035 WIRE WAS PLACED FOLLOWED BY A 4 FRENCH OMNI FLUSH CATHETER. THE CATHETER WAS PLACED BELOW THE LEVEL OF THE FILTER, AND IMAGES WERE PERFORMED. THE INFERIOR VENA CAVA WAS IN NORMAL SIZE. THERE WAS NO THROMBUS. THERE HAD BEEN MIGRATION OF ONE OF THE LEGS OF THE FILTER OUT OF THE INFERIOR VENA CAVA TO THE LEFT OF MIDLINE PROBABLY 2 CM. BECAUSE OF THIS FINDING THE INFERIOR VENA CAVA FILTER WAS NOT REMOVED. APPROXIMATELY THREE YEARS AND EIGHT MONTHS LATER, AGAIN THE FILTER REMOVAL PROCEDURE WAS PERFORMED UNDER FLUOROSCOPIC ASSIST. A BENSON WIRE WAS PLACED INTO THE DISTAL PORTION OF THE INFERIOR VENA CAVA USING THE COAXIAL EXCHANGE INTRODUCER AND 5-FRENCH SHEATH WAS THEN INTRODUCED. USING ULTRASOUND GUIDANCE ONCE AGAIN, A MICRONEEDLE WAS USED TO ACCESS THE RIGHT INTERNAL JUGULAR VEIN AND A WIRE WAS PASSED INTO THE INFERIOR VENA CAVA DISTALLY. NEXT, THE RETRIEVAL SHEATH WAS USED TO EXCHANGE OVER THE GUIDE WIRE AND THE RETRIEVAL SHEATH WAS POSITIONED ADJACENT TO THE TOP CAP OF THE FILTER. THE FILTER WAS SNARED WITH THE RETRIEVAL DEVICE AND REMOVED WITHOUT A DIFFICULTY. A FLUOROSCOPIC STUDY SHOWED THAT 1 OF THE LIMBS HAD PERFORATED THE INFERIOR VENA CAVA AND ADJACENT TO THE FOURTH PORTION OF THE DUODENUM, HAD BROKEN FROM THE DEVICE AND REMAINED IN PLACE. BOTH SHEATHS AND WIRES WERE THEN REMOVED. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR FILTER LIMB DETACHMENT AND RETRIEVAL DIFFICULTIES. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR FILTER TILT AND PERFORATION OF THE INFERIOR VENA CAVA (IVC). BASED ON 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. H10: D4(EXPIRATION DATE: 09/2011), G4, H6 (DEVICE: 4001) H11: H6(RESULTS AND CONCLUSION) H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT IN CONJUNCTION WITH TRAUMA SITUATION/MOTOR VEHICLE ACCIDENT. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER TILTED, STRUTS DETACHED AND PERFORATED. THE DEVICE WAS REMOVED PERCUTANEOUSLY AFTER AN ATTEMPTED BUT UNSUCCESSFUL OPEN CHEST PROCEDURE AND THE DETACHED STRUTS WERE REMOVED AFTER AN ATTEMPTED BUT UNSUCCESSFUL PERCUTANEOUS REMOVAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (DEVICE: 4001).

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT IN CONJUNCTION WITH TRAUMA SITUATION/MOTOR VEHICLE ACCIDENT. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER TILTED, STRUTS DETACHED AND PERFORATED. THE DEVICE WAS REMOVED PERCUTANEOUSLY AFTER AN ATTEMPTED BUT UNSUCCESSFUL OPEN CHEST PROCEDURE AND THE DETACHED STRUTS WERE REMOVED AFTER AN ATTEMPTED BUT UNSUCCESSFUL PERCUTANEOUS REMOVAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138107 G2 EXPRESS FILTER SYSTEM - FEMORAL VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFSI0005

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other| R