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.After, two days of post deployment, an x-ray lumbosacral spine was performed for back pain.The study showed the interval placement of inferior vena cava filter was noted.After, four days, a computed tomography of lumbar spine was performed which showed inferior vena cava filter was noted in malpositioned horizontally within the inferior vena cava.The foot plates may be protruding outside the inferior vena cava lumen.Around, four years and eight months of post deployment, an x-ray abdomen was performed which showed malpositioning of the inferior vena cava filter was noted at the level of l3 was stable.Around, twenty-eight days later, an x-ray abdomen was performed which showed stable malpositioning of an inferior vena cava filter.Around, four months and seventeen days later, an x-ray abdomen was performed which showed inferior vena cava filter was noted at the level of l3-l4.Around, one month and one day alter, on a computed tomography of abdomen and pelvis was performed which showed filter was noted in the inferior vena cava.Around, five months and three days later, an x-ray abdomen was performed which showed inferior vena cava filter was noted malpositioned and has a horizontal tilt.Around, two months and one day later, a computed tomography of pelvis was performed which showed inferior portion of the inferior vena cava filter was noted.Around, one year and one month later, a computed tomography of abdomen and pelvis was performed which showed inferior vena cava filter was noted with abnormal tilt and located essentially sideways in the infrarenal inferior vena cava with one limb projecting close to the aortic wall.One limb arose into the l5 vertebral body series and additional limb extends into the distal duodenum.The apex of the filter may lie outside the right lateral aspect of the inferior vena cava.Around, one month and three days later, a computed tomography of abdomen and pelvis was performed for right and left quadrant intermittent abdominal pain.The study showed that inferior vena cava filter with unchanged abnormal tilt with a horizontal orientation in the infrarenal inferior vena cava and limb erosion of filter.Multiple limbs in close proximity to the aortic wall and l5 vertebral body.Unchanged appearance of single limb in the distal duodenum.Retrieval hook appears extraluminal.Therefore, the investigation is confirmed the perforation of the inferior vena cava (ivc), filter tilt and material deformation.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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