It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with pulmonary embolism.At some time post filter deployment, it was alleged that the filter struts perforated, detached and tilted.The device has been removed percutaneously.The current status of the patient is unknown.
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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 pulmonary embolism.At some time post filter deployment, it was alleged that the filter struts perforated, detached and tilted.The device has been removed percutaneously.The current status of the patient is unknown.
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, seven years eight months of post-deployment, a computed tomography angio (cta) abdomen and pelvis was revealed that the filter was angulated with the tip pointing leftward and the prongs to the right, one extending into the vertebral body and one likely going into an adjacent renal vein on the left and one in the adjacent fat.After, three days, the patient was scheduled for the filter retrieval; the right internal jugular vein was accessed.The 10 french bard recovery cone system was advanced through the 12 french sheath and used to grasp and remove the filter.Despite the penetration of the filter legs outside the inferior vena cava and filter was removed easily.After removal, the filter was inspected, and it was discovered that one of the 6 arms was missing.The 6 legs were intact.The chest was examined under fluoroscopy and the fractured arm was identified in the right lung.Correlation with prior chest radiographs was revealed that the arm was in an unchanged position in the right lung.Therefore, the investigation is confirmed for the filter tilt, perforation of the inferior vena cava (ivc), and filter limb detachment.The definitive root cause could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 08/2012), g3, h6(method) h11: h6(result, conclusion) h11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Device not returned.
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