A moderate hematoma in the right groin and drop in hemoglobin and hematocrit resulted in anemia, which is a sequela of the hematoma.The patient was treated with hospitalization, laboratory tests and two units of whole blood transfusion.A ct of the abdomen and pelvis showed no evidence of a retroperitoneal bleed.Hematoma resulting in anemia are potential complication listed in the ifu and can occur after sheath removal.This clinical study sae is considered to be procedure-related and not related to the ekos device.No additional information will be available.
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Subject (b)(6) is a retrospective patient enrolled in (b)(6).This patient is a (b)(6) year old female.The patient had an abnormal ecg reading at baseline and history of tachycardia, transient hypo-hypertension (treated by medications) and diabetes.The patient's pre-procedural laboratory test results included 11.8 g/dl hemoglobin, 36.9%hematcrit and 122 k/¿ platlette count.The patient was treated for a bilateral pe on (b)(6) 2016 through (b)(6) 2016 for 24 hours.Ekos catheter was successfully placed using ultrasound imaging in the left and right pulmonary arteries.12 mg of tpa infusion was started on the same day at 22.14 hours.The planned therapy was completed at 22:14 on (b)(6) 2016.A moderate hematoma in the right groin and drop in hemoglobin and hematocrit resulted in anemia.Sae (anemia) start date (b)(6) 2016 and resolved on (b)(6) 2016.The patient was treated with hospitalization, laboratory tests and 2 units of whole blood transfusion.A ct of the abdomen and pelvis showed no evidence of a retroperitoneal bleed.Upper gi endoscopy showed la grade b reflux esophagitis.Recommendation to continue protonix and resume anticoagulation.The principle investigator classified the relationship of the anemia as not related to the ekos device and ultrasound therapy, but related to thrombolytic drug and anticoagulant drug.The interventional procedure was classified as unknown.
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