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 eleven months of post deployment, computed tomography angiography of chest, abdomen and pelvis with contrast showed that an inferior vena cava filter was in place.There was extensive thrombosis of the inferior vena cava and bilateral iliac veins.Inferior vena cava thrombus was noted above the level of the inferior vena cava filter.Emboli were visible in segmental branches of the pulmonary artery of the left lower lobe.The next day, computed tomography of abdomen and pelvis without contrast showed moderate retroperitoneal hemorrhage again, predominantly around the inferior vena cava, slightly smaller since prior study.Unchanged appearance of infra renal inferior vena cava filter.There was no evidence of right heart strain.Twelve days later, computed tomography of abdomen and pelvis with contrast was performed for abdominal pain and result showed that an inferior vena cava filter in place.Twelve days later computed tomography angiography of abdomen and pelvis with contrast showed that an inferior vena cava filter in position.Extensive thrombus throughout the inferior vena cava inferior to the filter extended into the bilateral common iliac, external iliac, and common femoral veins.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.Additionally, it can be confirmed that the patient experienced pulmonary embolism and thrombus above the filter 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.(expiry date: 11/2020).
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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 and pulmonary embolism.Approximately eleven months post filter deployment, a computed tomography (ct) revealed that the patient was diagnosed with pulmonary embolism and thrombus above the filter.The device has not been removed and there were no reported attempts made to retrieve the filter.However, the current status of the patient is unknown.
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