Manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.During deployment of the filter, there was incomplete release of several of the filter legs, which became trapped in the sheath.The legs were freed using the inner dilator with no permanent complications and was deployed successfully.Approximately one month post filter deployment, computed tomography revealed there was increased attenuation within the filter, inferior vena cava and extending into the common iliac veins with associated increased caliber of the inferior vena cava and iliac veins.Subsequently, next day follow up computed tomography revealed thrombosis of the inferior vena cava to the level of the filter and extending into the external iliac vein on the right and common iliac vein on the left.Successful venous thrombolysis of the inferior vena cava, bilateral common iliac veins, and right external iliac vein using an angio jet device and a total of 20 mg of t-pa with power-pulse technique was performed.Approximately four months later, computed tomography revealed indwelling denali ivc filter which was slightly canted to the left and the hook or proximal end of the inferior vena cava filter does abut and partially protrude beyond the wall margin of the inferior vena cava.Approximately five months later, patient scheduled for filter retrieval.Cavography revealed the hook appears to protect beyond the lateral margin of the endothelium.Subsequently, the bard snare removal system was introduced utilizing seldinger technique.The retrieval hook could not be snared, and this was likely based on wall adherence or partial penetration.Then, attempted to pass the guidewire between this adherent hook and the inferior vena cava wall, it was unsuccessful.The procedure was terminated at this point.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc), filter tilt, retrieval difficulties and failure to advance.Based upon 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.(device: 4001).
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It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis and pulmonary embolism.At some time post filter deployment, it was alleged that the filter tilted, apex perforated, failure to advance and unable to retrieve.The device has not been removed after unsuccessful percutaneous retrieve attempts.The patient was diagnosed with thrombosis at the level of the filter; however, the current status of the patient is unknown.
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