It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with pulmonary emboli.At some time post filter deployment, a computed tomography (ct) abdomen and pelvis with contrast showed that some of the distal prongs were seen outside the lumen of the inferior vena cava, within the mesenteric fat and abutted near the distal abdominal aorta.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with pulmonary embolism post implant; 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 review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately three months later, the patient suffered from chest pain and history of pulmonary emboli.On the same day, axial images using computed tomography angiography (cta) of the chest with intravenous contrast and image post-processing showed extensive thrombus formation in the right upper, right middle and right lower lobes.There was no pulmonary embolism on the left lobe.This could have been chronic in nature.Acute embolism cannot be totally excluded.After eight years and four months later, a computed tomography (ct) abdomen and pelvis with contrast showed that an inferior vena cava filter was noted with some of the distal prongs seen outside the lumen of the inferior vena cava, within the mesenteric fat and abutted near the distal abdominal aorta.Therefore, the investigation is confirmed for alleged perforation of the inferior vena cava.Additionally, it can be confirmed that the patient experienced pulmonary embolism post deployment.However, the relationship to the filter is unknown.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.H10: d4(expiry date: 09/2011), g4.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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It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with pulmonary emboli.At some time post filter deployment, a computed tomography (ct) abdomen and pelvis with contrast showed that some of the distal prongs were seen outside the lumen of the inferior vena cava, within the mesenteric fat and abutted near the distal abdominal aorta.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with pulmonary embolism post implant; however, the current status of the patient is unknown.
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