BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENALI FEMORAL SYSTEM

    MDR report key: 10142425 · Received June 11, 2020

    Report

    Report Number
    2020394-2020-03902
    Event Type
    Injury
    Date Received
    June 11, 2020
    Date of Event
    June 3, 2014
    Report Date
    July 8, 2020
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    UDI-DI
    00801741040801
    PMA / PMN Number
    K130366
    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: A LOT HISTORY REVIEW WAS PERFORMED. THIS IS THE ONLY COMPLAINT TO DATE FOR THIS LOT NUMBER. THEREFORE, A DEVICE HISTORY RECORD REVIEW IS NOT REQUIRED. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. LUMBER SPINE RADIOGRAPHY WAS PERFORMED, AND THE INFERIOR VENA CAVA FILTER WAS DEMONSTRATED WITH APEX AT THE LEVEL OF THE L2 VERTEBRAL BODY. LOWER EXTREMITY VENOUS DOPPLER ULTRASOUND WAS PERFORMED AND THERE WAS DEVELOPMENT OF OCCLUSIVE THROMBUS EXTENSIVELY THROUGHOUT THE LEFT LOWER EXTREMITY DEEP VENOUS SYSTEM INCLUDING COMMON FEMORAL VEIN, SFV AND PERONEAL VEINS. THE PREVIOUSLY NOTED OCCLUSIVE LEFT POPLITEAL VEIN DEEP VEIN THROMBOSIS WAS AGAIN NOTED. COMPUTED TOMOGRAPHY CHEST WAS PERFORMED AND MULTIPLE NEW PULMONARY EMBOLI WITH A LARGE CLOT BURDEN WAS NOTED. THE CLOT HAD CHANGED AND WAS LARGER THAN SEEN ON PRIOR EXAM. THIS PRESUMABLY REPRESENTED FAILURE OF THE INFERIOR VENA CAVA FILTER. COMPUTED TOMOGRAPHY ANGIOGRAPHY ABDOMEN, PELVIS AND BILATERAL LOWER EXTREMITIES WAS PERFORMED, THERE WAS AN INFRARENAL INFERIOR VENA CAVA FILTER AND SUPRARENAL INFERIOR VENA CAVA THROMBUS WHICH WAS AT THE LEVEL OF THE INFLOW OF THE RENAL VEINS. 2 YEARS 10 MONTHS LATER, COMPUTED TOMOGRAPHY WAS PERFORMED TO EVALUATE THE INFERIOR VENA CAVA FILTER. THE FILTER WAS LOCATED APPROXIMATELY 3.5 CM BELOW THE LEVEL OF LEFT RENAL VEINS, THERE WAS NO MIGRATION AND NO BENT OR FRACTURE. THE FILTER TIP WAS MILDLY TILTED POSTERIORLY AND THERE WAS A PERFORATION OF A RIGHT POSTEROLATERAL STRUT AT THE 8¿O CLOCK POSITION INTO PRECAVAL / MESENTERIC FAT. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE FILTER TILT AND PERFORATION OF THE IVC. HOWEVER ITS IS INCONCLUSIVE FOR THE ALLEGED FILTER MIGRATION. ADDITIONALLY, IT CAN BE CONFIRMED THAT THE PATIENT EXPERIENCED PE POST DEPLOYMENT. HOWEVER, THE RELATIONSHIP TO THE FILTER IS UNKNOWN. ADDITIONALLY, IT CAN BE CONFIRMED THAT THE PATIENT EXPERIENCED THROMBUS ABOVE THE FILTER POST DEPLOYMENT. HOWEVER, THE RELATIONSHIP TO THE FILTER IS UNKNOWN. 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(EXPIRY DATE: 05/2015), G4. 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 AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE FILTER MIGRATED, TILTED AND STRUTS PERFORATED THE VENA CAVA WALL AND TO THE MESENTERY. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: A LOT HISTORY REVIEW WAS PERFORMED. THIS IS THE ONLY COMPLAINT TO DATE FOR THIS LOT NUMBER. THEREFORE, A DEVICE HISTORY RECORD REVIEW IS NOT REQUIRED. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. LUMBER SPINE RADIOGRAPHY WAS PERFORMED, AND THE INFERIOR VENA CAVA FILTER WAS DEMONSTRATED WITH APEX AT THE LEVEL OF THE L2 VERTEBRAL BODY. LOWER EXTREMITY VENOUS DOPPLER ULTRASOUND WAS PERFORMED AND THERE WAS DEVELOPMENT OF OCCLUSIVE THROMBUS EXTENSIVELY THROUGHOUT THE LEFT LOWER EXTREMITY DEEP VENOUS SYSTEM INCLUDING COMMON FEMORAL VEIN, SFV AND PERONEAL VEINS. THE PREVIOUSLY NOTED OCCLUSIVE LEFT POPLITEAL VEIN DEEP VEIN THROMBOSIS WAS AGAIN NOTED. COMPUTED TOMOGRAPHY CHEST WAS PERFORMED AND MULTIPLE NEW PULMONARY EMBOLI WITH A LARGE CLOT BURDEN WAS NOTED. THE CLOT HAD CHANGED AND WAS LARGER THAN SEEN ON PRIOR EXAM. THIS PRESUMABLY REPRESENTED FAILURE OF THE INFERIOR VENA CAVA FILTER. COMPUTED TOMOGRAPHY ANGIOGRAPHY ABDOMEN, PELVIS AND BILATERAL LOWER EXTREMITIES WAS PERFORMED, THERE WAS AN INFRARENAL INFERIOR VENA CAVA FILTER AND SUPRARENAL INFERIOR VENA CAVA THROMBUS WHICH WAS AT THE LEVEL OF THE INFLOW OF THE RENAL VEINS. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED PERFORATION OF THE IVC, FILTER TILT AND FILTER MIGRATION. ADDITIONALLY, IT CAN BE CONFIRMED THAT THE PATIENT EXPERIENCED PE POST DEPLOYMENT. HOWEVER, THE RELATIONSHIP TO THE FILTER IS UNKNOWN. ADDITIONALLY, IT CAN BE CONFIRMED THAT THE PATIENT EXPERIENCED THROMBUS ABOVE THE FILTER POST DEPLOYMENT. HOWEVER, THE RELATIONSHIP TO THE FILTER IS UNKNOWN. 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. (EXPIRY DATE: 05/2015).

    Description of Event or Problem · 1

    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 MIGRATED, TILTED AND STRUTS PERFORATED THE VENA CAVA WALL AND TO THE MESENTERY. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608334 DENALI FEMORAL SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. DL900F GFXD3881 00801741040801

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening| O COUMADIN, LORTAB| COUMADIN, LORTAB| COUMADIN, LORTAB