CORDIS CORPORATION TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Model Number 466P306AU |
Device Problem
Fracture (1260)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 08/02/2019 |
Event Type
Injury
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Manufacturer Narrative
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Occupation: other, senior counsel, litigation.Please note that this is the initial report for this product.Additional information is pending and will be submitted within 30 days of receipt.
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Event Description
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As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to filter fractured at its inferomedial aspect.Two weeks before the index procedure the patient was seen for a gastrointestinal (gi) bleed and received six units of blood.On exam the patient was noted to have varicose veins bilaterally.Other medical history includes gi bleed due to esophageal varices, cirrhosis, secondary to liver sarcoidosis, portal hypertension, pre-hypertension, asthma, seizure, appendectomy, cystoscopy, traumatic injury ¿ right knee surgery and staples to head, right arm surgery.A venous duplex ultrasound was performed and revealed acute non-occlusive deep vein thrombosis of the left popliteal vein.According to the medical record the patient presented to the emergency department (ed) on with a one-day history of left lower extremity (lle) edema.The indication for the filter placement was deep vein thrombosis (dvt) and contraindication to anticoagulation.The filter was placed via the right common femoral vein and deployed in good position in the inferior vena cava (ivc), caudal to the renal veins.There were no immediate complications.Approximately two years and two months after the index procedure the patient underwent a computed tomography (ct) scan of the abdomen to evaluate the filter.Results of the scan noted a fractured or bent strut at the inferomedial aspect of the filter, the inferior tip of the filter abuts the posterior ivc wall.Incidental findings were splenomegaly, a portal caval stents/graft was present, and ground glass densities in the lower lungs.Additional information received per the patient profile form (ppf) states that the patient experienced filter fracture.The patient became aware of the reported events approximately two years and two months after the index procedure.The patient also experienced fear.
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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 filter fractured at its inferomedial aspect.The patient reported becoming aware of the event approximately two years and two months post implant.The patient also reported experiencing fear related to the filter.According to the medical record, two weeks before the index procedure the patient was seen for a gastrointestinal (gi) bleed and received six units of blood.On exam the patient was noted to have varicose veins bilaterally.Other medical history includes gi bleed due to esophageal varices, cirrhosis, secondary to liver sarcoidosis, portal hypertension, pre-hypertension, asthma, seizure, appendectomy, cystoscopy, traumatic injury ¿ right knee surgery and staples to head, right arm surgery.A venous duplex ultrasound was performed and revealed acute non-occlusive deep vein thrombosis of the left popliteal vein.The patient presented to the emergency department (ed) with a one-day history of left lower extremity (lle) edema.The indication for the filter placement was deep vein thrombosis (dvt) and contraindication to anticoagulation.The filter was placed via the right common femoral vein and deployed in good position in the inferior vena cava (ivc), caudal to the renal veins.There were no immediate complications.Approximately two years and two months post implant the patient underwent a computed tomography (ct) scan of the abdomen to evaluate the filter.Results of the scan noted a fractured or bent strut at the inferomedial aspect of the filter, the inferior tip of the filter abuts the posterior ivc wall.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The trapease ivc 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 pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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.The instructions for use 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.The timing and mechanism of the reported events has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported filter fracture could not be confirmed or further clarified.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.There is nothing to suggest that the reported event is related to the design and/or 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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