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.Approximately one month and seven days post filter deployment, an attempt was made to retrieve the filter, but unable to be removed due to the embedded inferior vena cava filter.Approximately three years and one month later, a fluoroscopy showed that there was a small prong of the inferior vena cava filter that could be seen probably in the right ventricle and an inferior vena cava filter was in the appropriate place in the inferior vena cava.Subsequently two days later, abdomen 1 view/kidney, ureter and bladder (kub) x-ray showed that the inferior vena cava filter was stable in position at approximately l3-l4 level.After 3 days, the patient reported to the hospital with clinical indications of chest pain, acute coronary syndrome, inferior vena cava filter strut within or adjacent to the heart.A computed tomography (ct) chest with contrast showed that a metallic foreign body was identified anterior to the right ventricular chamber either within the wall of the right ventricle or within the epicardial fat.Next day, a computed tomography (ct) abdomen and pelvis without contrast showed that an inferior vena cava filter was in place below the renal veins.Three limbs of the filter were seen exterior of the inferior vena cava and apex of the filter was positioned right anterior lateral in the wall.After 3 days, an attempt was made to retrieve the embolized foreign body in the right ventricle.During the course of angiography, a foreign body within the right ventricle was noted and was confirmed by echocardiography.The patient had continued chest pain, and a computed tomography (ct) scan of the chest showed that v-shaped foreign body was actually protruded out from the right ventricle into the pericardium with mild pericardial effusion and it was felt that this represented the component of the inferior vena cava filter that had embolized to the heart.A midline sternal incision was made, and the sternum was divided with an electric saw.The pericardium was then opened, that exposed the heart and ascending aorta.There was some small amount of bloody fluid within the pericardium.In the anterior and inferior portion of the wall of the right ventricle, the foreign body object that protruded out from the fat pad of the pericardium was easily recognized.This piece of the foreign body was a stainless steel metallic that was actually protruded out from the surface of the right ventricle.From the previous angiogram, it was known that this foreign body was a v-shaped component of the inferior vena cava filter, and it was then extruded from the surface of the epicardium from inside the right ventricle in its entirety because the v-shaped component was then taken out.Approximately eight months and ten days later, an x-ray chest 1 view portable showed that there was a stable appearance of tilted inferior vena cava filter with multiple metallic struts extended outside of the inferior vena cava wall and in stable configuration.On the same day, the patient experienced chest pain, abdominal pain and reported to the hospital.A computed tomography (ct) chest without intravenous contrast showed that a metallic strut from an inferior vena cava filter was longer seen at the epicardium of the right heart, consistent with interval removal.Also, a computed tomography (ct) abdomen and pelvis without intravenous contrast showed that a tilted inferior vena cava filter was again seen.Multiple metallic struts again noted to protrude outside of the inferior vena cava wall.There was no sign for adjacent hematoma.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc), filter tilt and filter limb detachment.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.(b)(4).
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