The site documented that the patient had a recurrent pe.The primary investigator (pi) assessed this event as not related to the interventional procedure, ekos system, or thrombolytic and probably related to anticoagulant drug.The medical monitor (mm) assessed the sae as probably related to interventional procedure and ekos system and not related to thrombolytic and anticoagulants drugs.There were no device malfunctions documented.The event was not reported to ekos at the time it occurred.While the medical monitor reassessed the sae of recurrent pe and determined that it was related to the ekos device and procedure, a review of source documents demonstrated that the patient had been discharged home after the initial pe on (b)(6) 2019.Doppler studies performed on (b)(6) 2019 revealed dvt in the right lower extremity.Btg believes the recurrent pe was related to the dvt and anticoagulation and not the ekos device, however this event is being reported based on the independent medical monitor's assessment.No additional information will be available.
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Subject (b)(6) is a patient enrolled in the (b)(6) study.This patient is a (b)(6) male.The patient was treated for a bilateral pe on (b)(6) 2019.It was reported the patient was diagnosed with dvt and recurrent pe on (b)(6) 2019 and was classified as a serious adverse event (sae).It is not known what intervention was performed to treat the recurrent pe.The source documents states that there were no complications during the procedure on (b)(6) 2019.The primary investigator (pi) assessed this event as not related to the interventional procedure, ekos system, or thrombolytic and probably related to anticoagulant drug.On 26 september 2019, btg became aware that the medical monitor (mm) reassessed the sae as probably related to interventional procedure and ekos system and not related to thrombolytic and anticoagulants drugs.
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