H10: 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, thirteen years two months post-deployment, an x-ray lumbar scan was performed, demonstrating inferior vena cava filter overlay the l2-l3 vertebrae.Multiple legs fractured from the filter with one lay immediately anterior to the central portion of the filter.Two others migrated several centimeters from the attachment point with one to the right of the l3 vertebral body and another to the right of the l4-l5 disc space.On the same date, the patient also had low back pain.Around, two months later, a computed tomography abdomen was performed, showing an infrarenal inferior vena cava filter was in place.The filter was slightly tilted with some prongs extended outside the inferior vena cava wall and two fractured prongs migrated.One was seen within the right renal hilum and another was seen adjacent to the right gonadal vein.There was no associated thrombosis or vascular injury and the venous structures were widely patent.After, thirteen days, a computed tomography angiogram was performed in patient reportedly experience back pain, demonstrating a portion of inferior vena cava filter was broken.Angiography was then performed showing no evidence of clot in the filter.Attempt to remove using the filter recovery system via internal jugular vein was not successful.A snare technique was attempted and made the filter tip over but could not remove.Patient tolerated the procedure well.Failure to remove filter endovascularly prompted open surgery.After five days, the inferior vena cava filter was dissected and noted with filter head extruding outside the inferior vena cava wall and two to three prongs sticking outside the vein.Longitudinal incision was made on the vein in order to remove the filter with all visible prongs.Patient tolerated the procedure well.Around, one month and twelve days later, post follow-up visit noted back pain was much better.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc), filter limb detachment, filter tilt and retrieval difficulties.However, the investigation is inconclusive for filter migration.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.H11:section a through f - the information provided by bd represents all of 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.
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