As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation; however, medical records were provided for review.The investigation of the reported event is currently underway.
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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.Approximately four years and four months post filter deployment, a computed tomography (ct) scan revealed that the filter strut detached.There were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain and hematuria; however, 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 deep vein thrombosis.Approximately four years and four months post filter deployment, a computed tomography (ct) scan revealed that the filter strut detached and perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experiences hematuria and abdominal pain; however, the current status of the patient is unknown.
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H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately four years and four months later, the patient presented to the hospital with hematuria and computed tomography (ct) was performed and it revealed that an inferior vena cava filter was below the level of the renal veins.The medial wall of the dilated right renal pelvis appears to have been transgressed by one of the tines of the inferior vena cava filter.It shows severe obstruction of right ureteropelvic junction (upj) with a tine from the filter eroding into renal pelvis.Approximately four months later, computed tomography (ct) revealed that one of the tines of the filter was again demonstrated transgressing the medial wall of a large right renal cyst about 13cm in diameter.Approximately three months and twenty-one days later an ultrasound abdomen complete was performed and it revealed two of the limbs of the inferior vena cava filter are anchored within the medial aspect of the cyst.Approximately two years and three months later, the patient complaint of abdominal pain.Approximately two months and four days later, a nephrostogram was performed and it revealed a broken inferior vena cava filter leg was noted.Therefore, the investigation is confirmed for alleged 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 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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