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 one year and two months of post deployment, patient presented to the emergency department with the complaints of nausea, vomiting, back pain and trouble breathing.Two days later, a computed tomography angiography of chest was performed for dyspnea.The study showed that presence of acute pulmonary embolism within branch vessels supplying the right upper lobe and right lower lobe.There was some junctional pleural reticular opacity within the right lung base, which probably represents developing pulmonary infarct.Three days later, a computed tomography of lumbar spine was performed for lumbar pain.The study showed that inferior vena cava filter was demonstrated within the course of the inferior vena cava.There was an enhancement of the right and left renal veins, but there was hypoattenuation within the central portion of the inferior vena cava at the level of the renal veins.This may be either secondary to the phase of contrast or there could be an underlying thrombus within the inferior vena cava.Four days later, patient presented with recurrent deep vein thrombosis, pulmonary embolism and totally occluded inferior vena cava filter.A bilateral lower extremity venous doppler study was performed for extensive edema.The study showed that right lower extremity extensive occlusive thrombus in the iliac, common femoral vein, greater saphenous vein, femoral vein, profunda vein, femoral vein and popliteal vein.Nonocclusive thrombus in the peroneal vein.Left lower extremity extensive occlusive thrombus in the iliac, common femoral vein, greater saphenous vein, femoral vein, profunda vein and femoral vein.Nonocclusive thrombus in the popliteal vein.The next day, patient was planned for bilateral lower extremity venography and initiation of catheter directed thrombolysis.An ultrasound of popliteal veins was performed which demonstrated occlusive thrombus within both popliteal veins.Ultrasound guidance puncture of popliteal veins were performed, and sheaths were placed in both popliteal veins.The thrombus was traversed in the right lower extremity and the catheter was advanced into the inferior vena cava above the filter.Digital subtraction venography was performed.There was an extensive occlusive thrombus involving the popliteal common femoral, common femoral and iliac veins.The thrombus extends into the inferior vena cava to the level of the inferior vena cava filter.Ekos catheter was advanced above the inferior vena cava under fluoroscopic guidance.Thrombolysis with tissue plasminogen activator (tpa) was initiated.Therefore, the investigation is confirmed for occlusion of inferior vena cava.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.
|