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Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately eight years and nine months later, the patient was diagnosed with acute pulmonary embolism.After three years, the patient presented with chest pain.On the same day, a computed tomography angiography (cta) chest with intravenous contrast showed negative for pulmonary embolism.On the next day, the patient presented with chest pain.On the same day, an echocardiogram completes showed that there was a trace posterior pericardial effusion.After one week, a computed tomography (ct) chest showed negative for pulmonary embolism.After three days, a computed tomography (ct) abdomen and pelvis without intravenous contrast showed that an inferior vena cava filter was in place.After three weeks, a computed tomography (ct) abdomen and pelvis showed a fragment within pericardial sac below xiphoid process.An infrarenal inferior vena cava filter with appropriate orientation was noted with 1 arm missing.After five days, the patient presented with left lower abdominal pain.On the same day, a computed tomography (ct) abdomen and pelvis demonstrated that the filter fractured fragment penetrated the myocardium and migrated into the pericardial sac below the xiphoid process.There was an infrarenal inferior vena cava filter, likely a bard g2 filter in appropriate orientation below the level of the renal veins, with 1 arm missing.There was a small to moderate pericardial effusion.After three days, an x-ray abdomen demonstrated there was a caval filter placed at the level of l2-l3.There were no fragments of filter superior to intact filter.On the next day, the patient presented with left lower abdominal pain and left back pain.On the same day, a computed tomography (ct) abdomen and pelvis showed that the inferior vena cava filter in renal vein was partially dislodged and 1 of the strut had migrated and eroded into the intra-pericardial space.On the same day, an attempt was made to remove the intrapericardial retained greenfield filter strut.A 2-inch incision was made below the xiphoid.The physicians dissected down to the fascia and to the pericardium.After some dissection, the physicians identified the strut easily; it was right in the top of the wound and on the bottom.Right anterior surface of the heart adherent to the pericardium, the strut from the greenfield filter was removed in total and the space was inspected.There was no pericardial space, just adhesions and inflammation.Meticulous hemostasis was achieved, and the wound was closed with vicryl sutures.After three days, the patient was diagnosed with pericardial effusion.On the same day, the patient¿s surgical pathology report gross description stated that ¿the specimen was received fresh labeled and ¿pericardial foreign body (inferior vena cava filter arm)¿ and consisted of a gray, bent wire that measured 2.4 cm in length with a diameter of less than 0.1 cm.No sections were taken.Gross only¿.After six days, an x-ray abdomen anteroposterior demonstrated that an inferior vena cava filter was noted.On the next day, an x-ray abdomen 2 views demonstrated that an inferior vena cava filter was noted.After two days, a computed tomography (ct) abdomen and pelvis with intravenous contrast demonstrated that a caval filter was noted.After four months, an attempt was made to remove the filter from the patient¿s body.Spot film imaging of the recovery filter showed the filter in normal position without significant tilt.All 6 legs and 5 remaining were intact.Partially occlusive thrombus was seen extended from the right common iliac vein up into the inferior vena cava filter.No clot was seen extended above the inferior vena cava filter.The infrarenal inferior vena cava above the filter, the central renal veins and immediate suprarenal inferior vena cava were normal.The physician aborted attempt to remove the inferior vena cava filter, due to iliocaval thrombus extended up into the inferior vena cava filter.The physician felt that an attempt to remove the filter would expose the patient to an unacceptable risk of pulmonary embolism and possibly preclude insertion of a new inferior vena cava filter.Insufficient room was present in the infrarenal inferior vena cava to allow placement of a new filter first, while still allowed for safe removal of the indwelling filter.A suprarenal inferior vena cava filter was not deemed appropriate at that time.Also, a venous duplex exam showed no evidence of deep vein thrombosis within the right or left extremities.Acute appeared superficial venous thrombosis was identified in the left leg, that involved the great saphenous vein in the proximal thigh.The thrombus was approximately 1.1 cm away from the common femoral vein.After six months, second attempt was made to remove the filter from the patient¿s body.Fluoroscopic examination of the filter was performed in multiple obliquities.Puncture of the right internal jugular vein was performed using ultrasound guidance and a 4 french micropuncture set.A 5 french berenstein catheter was introduced into the inferior vena cava below the filter over a bentson wire.Spot film imaging of the filter showed the filter in normal position without significant tilt.All remaining 5 arms and 6 legs were intact.There was no evidence of thrombus in the inferior vena cava, inferior vena cava filter, or visualized proximal iliac veins on the initial inferior vena cavogram.A bard recovery cone was advanced over an amplatz super stiff into the inferior vena cava and used to engage and remove the filter.The recovery filter was removed without incident.Contrast was injected through the recovery sheath and dsa imaging of the abdomen was performed as a follow-up cavagram to filter removal.The post filter removal cavagram demonstrated a normal inferior vena cava.Hemostasis was achieved.On the same day, the surgical pathology report¿s gross description stated ¿received fresh, labeled with the patient¿s name, medical record number and ¿inferior vena cava filter removal¿ was a metallic medical device that measured 4.5 x 2.0 x 2.0 cm in length, 1.0 cm in diameter.Specimen was for gross evaluation only¿.Also, a venous duplex exam showed no evidence of deep vein thrombosis within the right or left lower extremities.Previously documented, acute appeared superficial venous thrombosis was identified in the left leg, that involved the great saphenous vein in the proximal thigh.The thrombus was approximately 1.0 cm away from the common femoral vein.Therefore, the investigation is confirmed for the alleged filter limb detachment and filter occlusion.Additionally, it can be confirmed that the patient experienced pulmonary embolism post deployment.However, the relationship to the filter is unknown.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.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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