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H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, five days of post deployment, computed tomography of abdomen and pelvis with contrast was performed which showed there has been interval placement of an inferior vena cava filter for a patient with trauma.Around, six days later, computed tomography of abdomen and pelvis with contrast was performed which revealed an inferior vena cava filter in place for a patient with sepsis.After, four days, the patient had abdominal pain and there was an inferior vena cava filter in place.Around, eight years and four months later, computed tomography of abdomen and pelvis with contrast was performed for evaluation of central venous obstruction which showed inferior vena cava filter was somewhat inferior down at the level of the lower inferior vena cava just past the bifurcation.As a result, determination of thrombus within these vessels proximal to the proximal aspect of the low-lying inferior vena cava filter cannot be ascertained; although, with these varices, more central thrombus was probably likely.Around two months and twenty-eight days later, vena cavogram was performed which showed only trace flow around the periphery of filter, indicating near total occlusion.Tapering of inferior vena cava above the filter apex indicates that this was a chronic process.Given this occlusion about the filter, an attempt to pass it with a wire was not undertaken.Venogram revealed a large collateral from the distal inferior vena cava along the right border around the filter.This could be a potential pathway for clot migration.Around, two years three months later, on x-ray of spine lumbosacral and anteroposterior view of pelvis was performed for increasing low back pain which revealed inferior vena cava filter in place.Around, three months and three days later, computed tomography of abdomen was performed which showed stable inferior vena cava filter with its distal tip seen at the level of the superior end plate of l3 demonstrating a similar appearance and location when compared to prior computed tomography.After, four days, patient reports of a scan performed in previously where the inferior vena cava filter was clogged in place.Around, one year seven months later, computed tomography of abdomen without contrast was performed which showed infrarenal inferior vena cava filter was identified.No prominent tilting was identified.All six struts extend beyond the lumen of the inferior vena cava.No hematoma was noted.No perforation of the adjacent aorta or right common iliac artery was identified.The inferior vena cava filter was slightly inferior in positioning measuring 4.7cm below the level of the renal veins at the level of the aortic bifurcation.The struts of the inferior vena cava filter extend 5-6 mm beyond the lumen of the inferior vena cava.There was no focal fracture involving the filter or struts are identified.Therefore, the investigation is confirmed for the perforation of the inferior vena cava(ivc), filter migration and occlusion of the inferior vena cava (ivc).The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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.
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