CORDIS CORPORATION TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Model Number 466P306AU |
Device Problems
Fracture (1260); Unintended Movement (3026)
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Patient Problems
Coagulation Disorder (1779); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
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Event Date 12/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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Reporter occupation: other, senior counsel, litigation.(b)(4).Additional information is pending and will be submitted within 30 days of receipt.Please note that this is the initial report for this product.
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Event Description
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As reported by the legal department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, fracture, tilt, clot in filter, caval thrombosis.As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.Additional information received per the medical records indicate that the patient has a history of deep vein thrombosis (dvt).The filter was deployed via the patient's right common femoral vein using ultrasound guidance.The filter was placed below the level of the renal veins and above the level of the bifurcation of the inferior vena cava into the common iliac veins.The patient tolerated the procedure well with no immediate complications.Additional information received per the patient profile form (ppf) states that the patient experienced filter fracture within the inferior vena cava, tilt, blood clots, clotting and/or occlusion of the inferior vena cava (ivc).The patient became aware of the reported events sixteen years after the index procedure.The patient also experienced worry and was mentally disturbed.
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Manufacturer Narrative
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As reported a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused fracture, tilt, clot in the filter, and caval thrombosis.The patient reported becoming aware of filter fracture, tilt, blood clots, clotting and/or occlusion of the inferior vena cava (ivc), approximately sixteen years post implant.The patient also reported worry and was mentally disturbed.According to the medical records, the indication for the filter implant was a post-operative deep vein thrombosis (dvt).The filter was placed via the right common femoral vein and deployed below the level of the renal veins and above the level of the bifurcation of the ivc into the common iliac veins.The patient tolerated the procedure well with no immediate complications.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.An inferior vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient, vessel characteristics and pharmacological factors may have contributed to these events.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, specifically asymmetry and tortuosity.The instructions for use (ifu) states that filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Without images available for review the reported events could not be confirmed or further clarified.Given the limited information currently available for review, there is nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.
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