As reported, the patient underwent placement of an optease retrievable vena cava filter.The indication for the filter placement was not reported.More than fourteen years after the filter implantation, the patient became aware that the filter had tilted.The patient further reported having experienced anxiety associated with the filter.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.The optease vena cava filters is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) 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.Without images or procedural films for review, the reported filter tilt could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.Given the limited information available for review, there is nothing to suggest that a malfunction in 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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As reported by the legal brief, the patient underwent placement of an unspecified vena cava filter manufactured by cordis.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to filter tilting.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 suffer significant medical expenses, pain and suffering and other damages.According to the information received in the patient profile form (ppf), the patient reports being implanted with a cordis optease inferior vena cava (ivc) filter and reports tilting of the filter, becoming aware of the event approximately fourteen years and ten months after the filter implantation, and further experienced anxiety related to the filter.The additional information received for review included a couple of images of an abdominal computerized tomography (ct) scan which appear to show an ivc filter; however, a radiological report was not provided.
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