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Additional information received on 01jul2022: the left axillary artery and the left femoral artery were exposed, and an 8 mm fusion graft was anastomosed into the left axillary artery to form a blood supply channel.Radifocus + pigtail was inserted from the right femoral artery 8fr sheath and advanced to the ascending aorta and replaced with a lunderquist wire.In addition, pigtail cath was inserted into the descending aorta from the left femoral artery 5fr sheath.First, inserted the stent (zta-p-34-161-wl) so that the distal 4 cm landing zone is ensured from the aneurysm of the descending thoracic aorta.Then the second stent (zta-pt-40-36-217-wl) was inserted for the proximal side to barely cover the left carotid artery.At this point, although there was a type ia endleak in angiograph image, no obvious blood leakage to the outside of the aneurysm was observed.After this, a midline thoracic incision was performed, the pericardium was incised, and a moderate amount of serous pericardial fluid was observed.24fr, 28r and cannula were inserted into svc (superior vena cava) and ivc (inferior vena cava) from ra (right artery), and retrograde myocardial protection canula was inserted into cs (coronary sinus) from ra to make cpb (cardiopulmonary bypass) on.After that, vent was inserted into the lv (left vein) from the right upper pv and cooling was started.During cooling, svc taping and snare was performed.Furthermore, innominate vein, innominate a.It carotid a, and their surroundings were peeled off.The ascending aorta was also aneurysmal up to 55 mm and partially adhered to the surrounding area.When the lumen was seen as a circulatory arrest at a deep temperature of 25 ° c, the aorta arch to the ascending aorta was in the form of a true aneurysm.The three branches of the arch were also involved in the aneurysm, but the aneurysm at the area around the left carotid artery was partially mild as about 40 mm.The brachiocephalic trunk and the left carotid artery were dissected, and the proximal side of the left subclavian artery was closed with hem-o-lock.Two cannulas (15fr, 12fr) for anterograde cerebral separation and blood feeding were placed for the brachiocephalic trunk and the left common carotid artery, and blood feeding was started.Blood was sent to the left axillary artery from an artificial blood vessel set up in the axillary artery.A stent graft from another manufacturer was selected from the distal size, and the stent struts of the aortic stent graft near the distal stump was removed to enable anastomosis.Stent was trimmed to fit the distal anastomotic site, and then fixed at 4 points with the aortic wall and then wrapped with felt with darning thread and sawed it to the graft from another manufacturer.Felt was wrapped around the arch branches and anastomosed the left common carotid artery and the brachiocephalic trunk.After that, a connector was connected to the branches of the vascular graft.The base of the aorta was cut slightly proximal to the stj, and a collagen sponge coated and felt with darning thread were wrapped around it, and it was stitched by continuous stitching to the proximal of the vascular graft.During the rewarming, an 8mm fusion graft connected to the left axillary artery was guided to the anterior medial segment, and it was anastomosed to the remaining one branch of the graft from another manufacturer.After the rewarming was completed, the air was removed, then the lv vent off was removed, and then cpb weaning off was performed.However, after that a decrease in blood pressure and bleeding into the left thoracic cavity occurred, and a search revealed that the bleeding from the ruptured hole of the aneurysm recurred.An attempt was made to close the rupture hole, but the tissue was extremely fragile and difficult to anastomose.Performed the left 4th intercostal chest opening, added the blood transmission tube from the right femoral artery, started the artificial cardiopulmonary replenishment again.The distal descending aorta of the stent part was peeled and blocked with artificial blood vessel and right femoral artery blood supply.The proximal was blocked at the part of the distal side of the artificial blood vessel where a sewing margin could be made.When the aorta was incised, there was the endoleak from the intercostal artery and type iii endoleak as a lot of bleeding from the suture holes of the stent grafts.For the intercostal artery, stitches were made to stop bleeding.Then removed the distal of the stent first, and selected graft from another manufacturer branched according to the diameter of the distal aorta.Wrapped around the aorta with felt with a thread and distal continuous anastomosis was performed.In addition, about the proximal side, the distal end of the graft from another manufacturer was peeled off and exposed, all the stents were cut.The distal of other branches was continuously sutured to the graft from another manufacturer sutured to the descending aorta.At this time, after weaning the artificial cardiopulmonary system, it was confirmed that the bleeding was stopped, and additional arrest of bleeding for the intercostal artery was performed.Then, the patient was withdrawn from the artificial cardiopulmonary system and cpb was turned off.The physicians managed to control bleeding from blood vessels such as the anastomosis site of large vessel and the intercostal artery, but it was difficult to control oozing from the incision site, chest wall, etc., and became hypotension gradually due to anasarca due to long-term extracorporeal circulation and cardiac arrest.Hypotension prolonged, so v-a ecmo was attached.Also, the abdomen was significantly distended, and an exploratory laparotomy was performed as a gastroenterological consultant.Although there was severe edema in the intestinal tract, no ischemia was observed, and the operation was ended with the abdomen and chest open.After the operation, the blood pressure was maintained while administering blood transfusion.The administration of postoperative platelets seemed to reduce the bleeding from the drain, but the bleeding around the graft was 300 ml/h and the bleeding in the left thoracic cavity was 370 ml/h 1 hour.After that, while continuously infusing blood, v-a-ecmo was given at 3l/min, and the blood pressure remained stable but advanced acidemia progressed and bleeding did not stop.The blood coagulation ability was extended to the point where aptt could not be measured, and the fib quantification was well below the lower limit, resulting in a remarkable dic state.The amount of bleeding around the graft after returning to the room was 695ml, and the amount of bleeding in the left thoracic cavity was 4900ml.In total, 24 units of rbc, 24 units of ffp, and 20 units of pc were administered, but hb tended to decrease, the status of dic and acidemia did not change, and bleeding was uncontrollable.Although we considered stopping bleeding by re-operation, it is difficult to stop bleeding by surgery because of the dic state, and it is considered that there is a high risk of intraoperative death.No more blood to transfusion was ordered.After that, administering the remaining 12 units of ffp and 10 units of pc was finished, but the bleeding did not subside, and the blood pressure gradually decreased.The pump flow rate of ecmo decreased to l.7l/min and the blood pressure became constant at around 30/20mmhg, and the blood pressure by the heart itself almost disappeared and became completely dependent on the pump flow rate.The heart rate decreased with the blood pressure, and around 3:00, it became around hr40 and sp02 became undetectable.At 3:45 he suddenly became asystole from hr40.After that, no resuscitation attempt was performed, and the death was confirmed by the physician at am 4:00 on (b)(6) 2022.Additional information to questions received on 01jul2022 the suture holes endoleaks were loacted on plural suture holes on the graft.The intercostal artery supplied the flow to the type 2 endoleak.The endoleaks were visible on the angio.But it was not sure which type.It was thought to be type ia but type ii and type iii from suture holes were visible when the aorta was opened.Please see the operation record.An unsure type endoleak was observed after during tevar.
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Manufacturer ref# (b)(4).Summary of investigational findings: an 87-year-old male patient underwent emergency treatment due to a ruptured dissecting aortic aneurysm (daa).The procedure started at the night on (b)(6) 2022 and ended on (b)(6) 2022.The patient was treated with two stent grafts - zta-p-34-161-wl (complaint device) and zta-pt-40-36-217-wl.The physician first inserted the zta-p-34-161-wi (complaint device) with a distal landing zone on 4 cm ensured from the aneurysm of the descending thoracic aorta.Then the physician inserted the second stent graft (zta-pt-40-36-217-wl) as the proximal component with the proximal side of the stent graft to barely cover the left carotid artery.At completion of the tevar procedure a type ia endoleak ((b)(4), mfg ref# 3002808486-2022-00913) was observed on angiogram but no obvious blood leakage to the outside of the aneurysm was observed.Due to aneurysmal enlargement of the ascending aorta and aortic arch it was planned to replace the aortic arch by suturing this site together with the proximal stent graft.A triplex 30 mm vascular graft from another manufacturer was selected and the stent struts of the aortic stent graft near the distal aortic stump was removed to enable anastomosis.The stent was trimmed to fit the distal anastomotic site and fixed at 4 points with the aortic wall (using 4-0prolene).Then it was wrapped with felt and sawed to the triplex vascular graft.The left common carotid artery and brachiocephalic trunk were anastomosed to the triplex.The base of the aorta was cut slightly proximal to the stj (sinotubular junction) and it was stitched to the proximal part of the triplex vascular graft.A fusion graft connected to the left axillary artery was anastomosed to the remaining one branch of the triplex.Upon completion of the procedure the patient became hypotensive and bleeding into the left thoracic cavity occurred, and a search revealed that the bleeding from the ruptured hole of the aneurysm recurred.An attempt was made to close the rupture hole, but the tissue was extremely fragile and difficult to anastomose, and they had to perform left chest opening and put the patient back on extracorporeal circulation.When the aorta was incised, there was a type 2 endoleak from the intercostal artery and type 3 endoleak ((b)(4), mfg ref# 3002808486-2022-00873 and (b)(4), mfg ref# 3002808486-2022-00874) from the suture holes of the stent grafts.The intercostal artery was, stitched to stop bleeding and the distal stent graft was removed and replaced by a triplex 1-branched device.It is understood that the proximal stent graft was also removed and replaced with a non-cook device.The physician managed to control bleeding from blood vessels such as the anastomosis site of large vessel and the intercostal artery, but it was difficult to control oozing from the incision site, chest wall, etc., and the patient became hypotension gradually due to anasarca due to long-term extracorporeal circulation and cardiac arrest and va ecmo (venoarterial extracorporeal membrane oxygenation) was attached.An exploratory laparotomy was also performed and found severe edema in the intestinal tract, but no ischemia was observed.The operation was ended with the abdomen and chest open, and the patient admitted to icu.At icu the patient received multiple blood component transfusions due to bleeding around the graft and in the thoracic cavity, but the bleeding was uncontrollable resulting in acedemia and dic (disseminated intravascular coagulation) and expired on (b)(6) 2022.Review of the device history record gave no indication of the device being produced out of specification.A preoperative ct study and angiogram are provided and an imaging review is performed by an imaging expert.Per the imaging review "the complaint of a type 2 and type 3 endoleak and continued surgical bleeding leading to patient death is based solely on the report and cannot be confirmed from the imaging provided".The following is the imaging experts findings and impressions "bleeding into the chest cavity from the type 2 and type 3 endoleaks is due to a tear in the aneurysm sac wall.This could not be repaired primarily due to fragile tissue." and "the aneurysmal ascending aorta and arch had to be replaced by open surgical repair with direct anastomosis of the surgical graft to the proximal zta endograft.The proximal zta graft was modified with removal of the bare spring in situ and direct anastomosis to the aortic arch replacement graft.The type 3 endoleak seems to be from these surgical suture holes.The type 3 endoleak does not appear to be due to a graft issue, but to modification and suturing of the graft.The suture hole bleeding and continued surgical bleeding postoperatively is probably at least partially due to coagulopathy from the prolonged surgical procedure and extracorporeal circulation.The continued bleeding and hypotension ultimately led to the patient¿s demise." as a result of this event a clinical assessment has been performed by medical advisor.The medical advisor states "this is an emergency case where a patient was treated for aortic rupture (outside indication) with two proximal zta stent grafts components followed by a need for open replacement of the ascending aorta and arch due to anatomy assessed outside ifu.After initial tevar and anastomosis the case was complicated by bleeding from suture holes (type iii endoleak) and intercostal artery (type ii endoleak) into the chest cavity through the ruptured aorta.Regarding the type ii and iii endoleaks these were observed when the aorta was incised after the initial tevar and anastomosis.The type ii endoleak was, per report, confirmed due to bleeding from an intercostal artery and the type iii endoleak was stated to be due to bleeding from suture holes.It has not been possible to confirm the exact locations of the suture holes from which the bleeding was observed.Type ii endoleak, due to flow from intercostal arteries, is a known risk for endovascular procedures.The imaging reviewer indicated that the type iii endoleak could be due to the suture holes made by the physician when performing the anastomosis between the modified proximal stent graft and the aortic arch replacement graft.But it cannot be ruled out that bleeding could potentially have occurred from other suture holes, and in the report, it states ¿stent grafts¿ which could indicate not only the proximal stent graft.It should be noted that no explanted devices were returned for investigation.No evidence of a fault device can therefore be concluded and an exact cause regarding the type iii endoleak cannot be established based on the information.It is not clear if the open surgical repair with the anastomosis of the modified stent graft was planned from the beginning or if tevar had initially been considered the only treatment/part of bridging therapy.No planning information available but it is noted it was an emergency case." the following is reported "type iii endoleak from plural suture holes of the two zenith devices" and two complaints regarding type 3b endoleak is opened to address both the proximal and distal placed zta components.Stent graft modification of the proximal placed zta-pt-40-36-217-w1 ((b)(4)) is confirmed however, it is not confirmed that any stent graft modification for the distal placed zta-p-34-161-w1 (complaint device) is performed.The stent grafts was not returned for device evaluation and no imaging where the type 3b endoleak is present are provided.Based on the provided information, the imaging review and clinical assessment an exact cause for the type 3b endoleak in this complaint cannot be established, however, it is possible that the endoleak was due to suture holes or handling or exposure to sharp instruments during the anastomosis.Coagulopathy from the prolonged surgical procedure may have contributed to the continued bleeding which led to the patients demise.In addition it is noted in the instruction for use that the safety and effectiveness of the zenith alpha thoracic endovascular graft and ancillary components have not been evaluated in patient having leaking, pending rupture or ruptured aneurysm and dissections.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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