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Product complaint #: (b)(4).Review of work order (b)(4) (flex4), manufacturing lot 18043444: the probe used at the case ((b)(4)) was in-process serial number #(b)(4).It had no issues during manufacture.Everything was in spec and it passed all testing.Additional event information provided: event start date: (b)(6) 2018, event description: bleeding during navigation.Event start date: (b)(6) 2018, event description: blood in airway after ebus.Event start date: (b)(6) 2018, event description: onset of more acute type of pain in the chest/pain and shortness of breath.Event start date: (b)(6) 2018, event description: shortness of breath and back pain.Event start date: (b)(6) 2018, event description: ablation syndrome.Event start date: (b)(6) 2018, event description: hemoptysis.Event start date: (b)(6) 2018, event description: cough.Event start date: (b)(6) 2018, event description: "hemmorhage"- nos, outcome: fatal.Additional information provided by medical director: medical director was in the case and reported that as this was the first case; it took longer for anesthesia and for the case to get started.During the bronchoscopy, there was some mucosal bleeding that took several minutes to control which was not a significant event and is not uncommon.The procedure continued and there was a lengthy amount of time spent placing the probe.Abandoning the procedure was considered, but imaging at that point confirmed that the probe was exactly where it needed to be.The decision was made to proceed with the ablation, which was uneventful.The patient wanted to go home that day but was admitted overnight per the protocol and was doing well.On the day before the patient¿s demise, the patient reported to another hospital with posterior left chest pain.A ct scan was done and shared for review.The ct showed a generous ablation including involving the lining of the lung and pleura, which is typical of even the percutaneous ablation procedures; the ablation zone was sizeable but not atypical.Dead material was observed with no blood or fluid identified.It was determined to be symptomatic discomfort and the patient was sent home on steroids.The following day while at a gas station, the patient collapsed and, as reported by a witness, hit his face on concrete.The paramedics attempted treatment for cardiopulmonary arrest, including intubation.There was quite minimal bleeding in the nasal track.The patient was reported to be asystolic from the time found.It was reiterated that there had been minimal bleeding throughout patient care and it was added that the ablation zone was not near the pulmonary artery.There was discussion about potential causes which included the discussion of hemoptysis.Medical director explained that there would have been significant bleeding if the patient event was related to hemoptysis.The family refused an autopsy, but it is felt that this is unlikely a delayed event related to the ablation.The patient death was likely due to a sudden cardiovascular event but there is no proof as no autopsy was performed.During the discussion, it was also reported that the patient was on plavix.Narrative surrounding the events of (b)(6) ¿ serious adverse event (sae) provided by m.D.That performed the ablation procedure: history: patient is a (b)(6) male with known chronic lymphocytic leukemia and 2 nodules on the ct scan.The patient underwent bronchoscopic biopsy on (b)(6) and the lower lobe nodule was found to be biopsy proven squamous cell cancer.At the time of presentation, the patient had borderline pulmonary function testing and was thought to be very borderline operable.As such, he was counseled on stereotactic body radiation therapy (sbrt), surgery, percutaneous ablation, and a trial on bronchoscopic microwave ablation.After detailed discussions, the patient chose bronchoscopic microwave ablation.He was aware he would be the first patient to undergo this procedure at (b)(6) clinic and the 8th person nationally as part of the study.As part of study protocol, he had new pulmonary function tests (pfts) within 30 days, upon which time they had surprisingly improved.He was called prior to returning to (b)(6) for the ablation procedure and informed that surgery would now be a viable option.He chose to have the bronchoscopic microwave ablation procedure.Intraoperatively: standard endobronchial ultrasound guided lymph node biopsy (ebus) was performed without difficulty.We then attempted to navigate to the lesion with both augmented fluoroscopic guided and electromagnetic navigational guidance.This was a difficult navigation.At one point during the navigation we did encounter a modest amount of bleeding (about 100-150cc of blood).This stopped with cold saline and tamponade.We then proceeded with navigation and confirmed that we were within the nodule using cone beam ct.We reviewed the imaging prior to ablation with a (b)(6) expert in interventional radiology as well as the designated clinical proctors who were part of the sponsoring trial team.Ablation was then performed with collective agreement amongst both proceduralists and clinical proctors to complete a 10 minute ablation at 100 watts.We repeated a cone beam ct scan at 5 minutes and at 10 minutes to confirm out ablation zone.Post ablation cone beam ct was performed at 10 minutes post ablation and reviewed by all parties mentioned above and no obvious concerns were noted and felt the case was successful.Post-procedure: patient was observed for 24 hours with no adverse events.He was ambulatory within hours of the surgery.He was dismissed in good condition.He notified the service on post procedure 2 about chest pain and was sent to the emergency department to rule out pneumothorax.He was prescribed steroids for ablation syndrome.The patient did note that he has been having ongoing claudication with cessation of his plavix in preparation for the procedure.As such we advised that he wait 24 hours and then resume his plavix per his routine regimen.He then notified the service on (b)(6) and i called and spoke with him directly regarding his symptoms.He stated at that time that he had some mild fatigue and occasional exertional dyspnea but the pain medication and steroids did gradually improve his symptoms from the week prior.He was instructed to continue with the current regimen but call at the end of the week if no improvement.I received a message in my inbox on (b)(6) that the patient had presented to the emergency department on (b)(6).He had laboratory workup and ct scan and physical examination.The emergency department physician had noted thin bloody sputum without evidence of clots.The hemoglobin was 10.8 from 12.0 pre-procedurally and white blood cell count was 15.Of note the patient was on plavix for peripheral arterial disease with stents in place and was also on steroids for post ablation syndrome.The overall impression was ¿patient should be treated like traumatic lung injury in regards to ablation.¿ he was discharged with antibiotics and per report the on-call covering resident was notified at 10:54 p.M.Here in (b)(6).We have reached out to the resident to document their conversation with the emergency department.I received notification of the patient's ct scan on (b)(6) 2018.We plan to contact the patient on the morning of (b)(6) 2018.When i logged in to retrieve his information i noted that there was yet another adverse event in his chart.Per documentation from the outside emergency department at 1700 p.M.On (b)(6) 2018, the patient was found down at a local gas station and was in asystole and was rushed to the local emergency department.The initial report from ambulance is that they were having difficulty with suctioning and establishing airway.Upon arrival patient was profusely bleeding from the mouth and remained in asystole with cpr in progress.Per emergency department (ed) report: ¿iv access was established, patient was placed on cardiac monitoring and pulse oximetry.Pads from the crash cart replaced as well and the lucas device was placed on the patient's chest and turned on.I did attempt to intubate the patient, upon looking with the laryngoscope i was met with copious amounts of blood that seemed to be emanating from the airway.There were large clots throughout the mouth and in both nares.After extensive suctioning i was able to visualize the epiglottis and what i believe was the anterior portion of the vocal cords.The tube was inserted and cuff inflated.We did not have end-tidal co2 immediately available at that time.Patient initially bagged without difficulty; however, this did become more difficult with time.Patient's stomach did become more distended and we had some difficulty passing the ng tube.Patient received 2 rounds of epinephrine and chest compressions continuously with the lucas device.We did stop for pulse check before each epinephrine administration and after the 1st round of epinephrine we had pea on the monitor, after the 2nd epinephrine administration patient was in asystole.At this point given the patient's fixed and dilated pupils, the copious amount of bleeding from the airway and the time that we had run the code both in the emergency room and in the ambulance which totaled about 30 min we made the decision to cease life saving efforts.Time of death 1620.I then took some time to review the patient's charts and familiarize myself with who (b)(6) was as he was initially an unknown entity for about half of the code.I notified his brother at 1640.Coroner was also called¿.No autopsy is planned.Additional information was requested and the following was obtained: when was the plavix stopped prior to the ablation procedure (exact date)? plavix was stopped 48 hours prior to the diagnostic bronchoscopy ((b)(6)).He was told not to resume his plavix between the (b)(6) bronchoscopy and (b)(6).When was the exact time/date the patient resumed plavix in relation to the procedure? the patient resumed plavix the day after the procedure (unknown exact time as he was dismissed) ¿ but he was complaining of claudication and had stents in his leg do you believe that an alleged deficiency with the neuwave device caused or contributed to the patient¿s death? no i do not believe this to be a deficiency with the probe ¿ i think it was likely poor patient selection and perhaps the bleed during the navigation should have caused us to abort ¿ where we had trouble was navigating to his lesion, once we did, the ablation part was very smooth and facile (with no additional bleeding whatsoever).In hindsight, we should have probably paused after the bleeding episode and thought about delaying the ablation until we made sure the bleeding was controlled with no sequelae.I do not believe this had anything to do with the neuwave probe.Also, about the discrepancy between the medical director's account and narrative from the m.D.That performed the ablation procedure: as i was obviously not notified of the patient¿s demise until after it happened, what i provided is a direct copy/paste of the emergency departments findings when he arrived there.However, in accordance with the medical director's narrative, when the patient was initially seen to collapse at the gas station, this was not preceded by a "hemetemesis" or hemoptysis event.Data safety monitoring board (dsmb) conclusion summary: the events of bleeding during navigation (ael) and death were both probably procedure related owing to the temporal sequence of events documented at the time of the procedure and subsequently upon review of available records through the time of the patient's death.The committee agrees the subject's death was probably caused by the hemorrhage described at the time of resuscitation which was contributed to by the initial sentinel bleeding event.The bleeding during navigation and death were both possibly device related as the stiffness of the device may have been more prone to puncture.However, the consensus is that technique and not the device is the more proximate cause of the initial complication.
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