It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter struts detached and retained in lung base.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced chest pain; however, the current status of the patient is unknown.
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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.Approximately eleven years post filter deployment, x-ray chest posteroanterior and lateral revealed there was a linear metallic approximately 2.2 cm tiny foreign body, probably in the right lower pulmonary artery.Broken limb of the inferior vena cava filter with pulmonary dislodgment was suspected.Approximately one year later, chest single view revealed small linear radiopaque foreign body within the medial right lower lobe consistent with broken limb from the patient¿s inferior vena cava filter that extended into the right lower lobe pulmonary artery.Subsequently, a few days later computed tomography revealed there was a small linear metallic density noted in right lower lobe posterior or medial basilar subsegmental artery consistent with prior fracture of a strut of the inferior vena cava filter with migration of a strut into the pulmonary arterial tree.Approximately one month later, the patient visited the hospital with the compliant of sharp stabbing chest pain and shortness of breath and radiation to the right breast.Therefore, the investigation is confirmed for filter limb detachment.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.
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It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter struts detached and retained in lung base.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced chest pain; however, the current status of the patient is unknown.
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