Manufacturing review: a 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 one month later, the fluoroscopic spot image revealed that the inferior vena cava filter was tilted slightly toward the right by approximately 30-degrees.Approximately thirteen years later, computed tomography (ct) revealed the inferior vena cava filter was tilted along the course of the patient¿s inferior vena cava.The apex of the filter was touching the right lateral inferior vena cava wall.The inferior vena cava filter tip was located below the lowest renal vein and not greater than 2 cm below the lowest renal vein.Multifocal lower filter strut perforation along the left side of the inferior vena cava with a posterolateral left filter strut was extending posteriorly to the abdominal aorta in a prespinal location.Fractured discontinuous and displaced filter struts were outside of the inferior vena cava, one fragment along the medial margin of the right psoas muscle and one fragment was at anterior to the inferior vena cava and tangent to the duodenum.A third small fragment was situated anterior to the spine.A fourth fragment was significantly inferiorly displaced and was situated along the anterior margin of the right psoas muscle at the iliac crest level.Therefore, the investigation is confirmed for filter limb detachment, perforation of ivc filter, and filter tilt.Based on 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 after being diagnosed with deep vein thrombosis/pulmonary embolism and in conjunction with or before orthopedic procedure.At some time post filter deployment, it was alleged that the filter detached, tilted, struts perforated into the wall of inferior vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.It was further reported that one detached strut was retained along right psoas muscle, one anterior to the ivc, one is situated anterior to the spine and one inferiorly displaced along right psoas muscle.The current status of the patient is unknown.
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