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Udi: (b)(4).The undated surgical report provided indicates the following diagnosis at the time of implant: "chronic renal failure, stage 1." however, it is unclear from the records provided when the patient received this diagnosis.Medical records with lab results indicating the patient¿s pre- and post-operative creatinine levels were not provided to gore.Additionally, medical records detailing the patient¿s medical history were not provided to gore.Furthermore, the (b)(6) 2017 autopsy report indicates the following: "in the post-operative phase, the patient is supposed to have developed acute renal failure, which was supposed to have been treated with volume administration and diuretics, and later with the help of hemofiltration." however, the autopsy indicates the cause of death as ¿central cardiovascular failure,¿ with the following ¿underlying diseases¿ being noted: ¿1st recent brain bleed right occipital.2nd general arteriosclerosis.3rd status post aortoiliac stent-graft prosthesis implantation because of penetrating aortic ulcer (pau).4th coronary heart disease.5th diverticulitis and peridiverticulitis with sigmoid.6th diverticulosis.Nodular prostate hyperplasia with [sic].¿ renal or kidney failure is not indicated as a cause of death or underlying disease in the provided autopsy report.Medical records detailing the patient's post-operative course were not provided to gore.Gore is unable to determine the relationship between the intra-procedure device event and the post-operative renal failure with the information provided.(b)(4).Evaluation summary: the gore® excluder® aaa endoprosthesis was returned to gore and an engineering evaluation was performed on the explanted endoprosthesis.The evaluation was based only on the event description as reported to gore and visual inspection of the returned device.No deployment system components were returned to gore for evaluation.The deployment sleeve was not attached to the device.Blood residue was observed on the returned device.Engineering observed that the contralateral gate remains closed after complete removal of the deployment system.It does not appear that the deployment system components played a role in keeping the contralateral gate from opening.It is not possible to determine the reason for the contralateral gate remaining closed through visual examination of the returned device.The preliminary findings of the explant evaluation are that an unidentified non-biological material was present in the contralateral gate.The findings in the engineering evaluation are consistent with the reported observation that cannulation was not possible as well as the reported lack of contrast passing through the gate.Further investigation will be conducted as necessary in the quality system.Additional details regarding the patient¿s clinical course were ascertained from a review of medical records and are as follows: an undated surgical report describes a medical procedure as follows: ¿the marker catheter is inserted over the terumo wire up to the level of the suspected renal artery outflows (the left renal artery exits significantly deeper), is positioned, and the terumo wire removed.From the left, the 6 french sheath is removed and exchanged for the 16 french sheath.The 16 french sheath is pushed forward until it stops, and after removing the insertion aid, the main trunk of the prosthesis is inserted under x-ray guidance so that the contralateral device leg exits exactly horizontally.The position is selected in such a way that it comes to lie just below the outflow of the suspected left renal artery, this at the lower margin of the second lumbar vertebra.¿ the undated surgical report continues: ¿from the right, the angiography is conducted with the contrast medium pump¿the outflows of the renal arteries and the aortic bifurcation are marked on the screen, and the trunk of the prosthesis is partially deployed, until the contralateral right device leg springs up.The position of the trunk of the prosthesis is directly below the outflow of the left renal artery.From the right, the terumo wire is inserted and the pigtail catheter elongated and finally withdrawn.The terumo wire is withdrawn to below the contralateral device leg.¿ the undated surgical report states: ¿a vertebralis catheter is inserted and an attempt made to probe the contralateral leg of the device.This does not succeed after several attempts, so that the catheter is exchanged for a pigtail catheter and then again for a bern catheter, without being able to cannulate the contralateral device leg.Finally, contrast dye is injected by hand via the inserted sheath on the right side.We see that the contrast dye reaches to the contralateral device leg.We also see, however, that a dissection may have occurred in the common iliac artery.The undated surgical report continues: ¿now i ask for head physician dr.Moisin¿so that he can perform the cannulation, possibly even via the arm.He also first attempts via the right groin, and does not succeed.Finally, after washing and sterile covering of the left arm, he cannulates the brachial artery and attempts, from there, with various catheters, to cannulate the contralateral device leg from the arm.During this procedure, he lands several times in different visceral arteries.This does not succeed.The angiography control of the left arm shows that the trunk of the prosthesis is filled with contrast dye, but neither leg of the prosthesis can be imaged.¿ the undated surgical report states: ¿at this point, the left prosthesis leg has not yet deployed, and this is why it cannot be imaged.The contralateral right device leg also cannot be seen.No contrast dye flows through it into the right pelvic artery, so that it can be assumed that this leg is closed, whether due to the suspected dissection in the common iliac artery on the right side or due to another reason that cannot be explained.Finally, after a long time of trying via the arm to cannulate the contralateral right device leg, another angiographic control from the right arm is conducted.We see the outflow of the left renal artery, the trunk completely filled with contrast dye, but neither leg can be imaged and no contrast due continues to reach the right pelvic artery as well, so that i device to make an aortouniiliac reconstruction out of it and to conduct a cross-over bypass to supply the right leg.¿ the undated surgical report continues: ¿to make certain that this is a possible path to spare the patient an open operation, i contact the vascular surgery department¿by telephone.I explained the situation to the responsible senior physician on duty, dr.Donas.He also advised me to retain the aortouniiliac situation as it now prevails, to create a cross-over bypass, and at this point, to refrain from an open operation with the explantation of the indwelling stent-graft prosthesis.He suggested that i close the right pelvic artery and also the right leg of the stent-graft prosthesis with a suitable closure system in the same session.I indicated that i do not have this closure system available at the moment and offered to transfer the patient immediately to muenster for this procedure.My colleague did not consider this necessary at the moment, insofar as he could assess based on the information i gave him over the telephone, so that i now tread the path of adding an aortouniiliac prosthesis.¿ the undated surgical report states: ¿for this purpose, an angiography was conducted from the arm in order to document the patency of both renal arteries and the correct position of the stent-graft prosthesis.Because of this angiography, it is necessary to push the stent-graft prosthesis down a bit since the left renal artery appears partially covered but still perfused.The repeated angiographic control from the arm now shows good perfusion in the left renal artery, so that now, after x-ray imaging of the outflow of the internal iliac artery on the left side and marking of this outflow on the screen, the left device leg is deployed.The undated surgical report continues: ¿finally, with the balloon, the left leg and the prosthesis trunk is remodelled, and finally the pigtail catheter is brought in from the left and, again, a final angiography is conducted.No endoleak is seen.Both renal arteries are well perfused.No contralateral device leg is seen and no filling of the right pelvic artery.After all wires are removed, both sheaths are removed and the arterial cannulation sites on the right and left each closed with single button sutures.¿ the undated surgical report states: ¿imaging of the common femoral artery on both sides now, in its total length.First on the right side, after clamping the proximal and distal common femoral artery, a longitudinal arterectomy is conducted.No dissection is seen here.An 8 mm ringed silvergraft prosthesis is anastomosed end-to-side, guided subcutaneously to the left side where it is also anastomosed end-to-side, and finally the blood flow to both legs is released.Insertion of a redon drain in both groins.Single button suture of the fascia, single button suture subcutaneously and skin closure using a staple line.Sterile dressing in both groins and end of the operation.¿ the undated surgical report continues: ¿post-operatively, the dorsal pedal artery and the posterior tibial artery on both sides can be easily dopplered.Both feet are pink and warm.¿ ¿the hand is warm and pink.The radial artery pulse is not palpable on the left side, and the arterial pressure measurement in this artery lies in the area of the wrist.The patient has stable circulation and is transferred to the intensive care unit with ventilation.It is planned to continue the ventilation over night.¿ the undated surgical report provides the following diagnoses: ¿penetrating aortic ulcer (pau) with aortic sclerosis; status post conservatively treated, complicated sigmoid diverticulitis; arterial hypertension; chronic renal failure, stage 1; hypercholesterolemia; nicotine; and previously known damage to hepatic parenchyma (see discharge letter from our institution).¿ the indicated discharge letter was not provided to gore.Medical records with lab results indicating the patient¿s pre- and post-operative creatinine levels were not provided to gore.Additionally, medical records detailing the patient¿s medical history were not provided to gore.Medical records detailing the patient¿s post-operative course after treatment of the pau were not provided to gore.An autopsy report dated (b)(6) 2017 indicates ¿central cardiovascular failure¿ as the cause of death.The report also provides the following underlying diseases: ¿1st recent brain bleed right occipital.2nd general arteriosclerosis.3rd status post aortoiliac stent-graft prosthesis implantation because of penetrating aortic ulcer (pau).4th coronary heart disease.5th diverticulitis and peridiverticulitis with sigmoid.6th diverticulosis.Nodular prostate hyperplasia with [sic].¿ the (b)(6) 2017 autopsy report provides the following pathological-anatomical findings and epicritical assessment: ¿according to clinical information, the patient had been implanted with an aortoiliac stent-graft prosthesis due to a penetrating aortic ulcer (pau) with aortic sclerosis in order to eliminate the pau.In addition, a half-closed fasciotomy of three compartments in the lower leg (right) with impending compartment syndrome on had been performed on (b)(6) 2017.¿ medical records dated (b)(6) 2017 were not provided to gore.The autopsy report continues: ¿the abovementioned operative (i.E.The stent implantation) was done on (b)(6) 2017.During the operation, the surgeon did not succeed in cannulating the contralateral right device leg in order to dock the extension piece.However, no transfer of contrast due from the prosthesis trunk into the right pelvic axis occurred.¿ ¿in the post-operative phase, the patient is supposed to have developed acute renal failure, which was supposed to have been treated with volume administration and diuretics, and later with the additional help of hemofiltration.On the morning of (b)(6) 2017, the patient developed bradycardia and hypotension with subsequent atrial fibrillation, to complete surprise of the doctors.Resuscitation and defibrillation were performed immediately, but these measures were without success.The patient then died around 8:20 a.M.¿ the autopsy report states: ¿a significant finding was that, in the dissection of the brain, an at most 2.5 cm large recent brain bleed in the area of the right occipital lobe was found.However, no convincing morphological substrates were found which allowed conclusions to be drawn regarding the etiopathogenesis of this recent brain hemorrhage.In particular, the typical histopathological picture of a cerebral infarction did not show up, nor were there indications of a brain tumor or a vascular anomaly in the sense of an aneurysm.In addition, there were also no typical findings of a brain mass hemorrhage as can be observed in the context of hypertension.Brain edema resulted from this recent brain hemorrhage.¿ ¿the symptoms indicated from the clinical side on the morning of (b)(6) 2017, with bradycardia and hypotension, point, in this connection to a bulbar brain syndrome in the context of the brain constriction described above, with failure of the brain stem reflexes due to compression of the medulla oblongata.¿ the autopsy report continues: ¿another underlying condition was a general arteriosclerosis that was accentuated in the abdominal aorta and in part significantly calcified.As part of this arteriosclerosis, a so-called penetrating aortic ulcer (pau) with secondary thrombosis was detected in the lower infrarenal section of the abdominal aorta, measuring approx.2 cm.The autopsy revealed no further complication in this area of this lesion, especially no retroperitoneal bleeding.The opening of the abdominal aorta showed a normally positioned and continuous left aortoiliac stent-graft prosthesis as well as a so-called cross-over bypass from the left to right.The latter, according to the clinical information, had been necessary because, during the surgery, the so-called right device leg of the prosthesis could not be cannulated in order to dock the extension piece.The autopsy report states: ¿the approximately 6 cm long thrombose detected in the area of the common iliac artery (right) is apparently the result of the described inability to cannulate the so-called right device leg of the prosthesis.The operation, according to the clinical information, was conducted using an endovascular or conventional procedure and involved overall normal surgical conditions.Secondary findings in the context of the described surgery include the 9.5 cm long wound in the left groin area closed with staples and the 8.5 cm closed wound in the right groin area.There were also surgical wounds up to 7 cm long in the area of the right lower leg (due to suspected threatening compartment syndrome, according to the information).¿ the autopsy report continues: ¿coronary artery disease must also be documented as an additional underlying illness.Histologically small ossified subendocardial myocardial fibrosis was found in the anterior wall of the left ventricle in the context of a partly significant stenosis and calcified coronary sclerosis in the anterior interventricular branch of the left coronary artery.But there was no morphological evidence for an acute coronary insufficiency in the sense of an acute myocardial infarction.The heart valves showed unremarkable conditions with no indicators of endocarditis.¿ the autopsy report states: ¿other underlying diseases were a partially florid diverticulitis and peridiverticulitis with sigmoid diverticulitis and a nodular prostate hyperplasia with prostate infarctions.The autopsy revealed no evidence of gastrointestinal bleeding, pneumonia, pulmonary arterial thromboembolism, nephritis or hepatitis, as well as no evidence of malignant tumor.¿ the autopsy report concludes: ¿in summary, the patient, taking into consideration the clinical information as well, died from an acute bulbar brain syndrome with central cardiovascular failure in the context of a recent right occipital brain hemorrhage.The morphological findings show no convincing evidence of the etiopathogenesis of this brain hemorrhage.In my opinion, there is no connection with the surgical intervention.¿ the european instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states that the gore® excluder® aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease and who have appropriate anatomy, including an infrarenal aortic neck treatment diameter range of 19 ¿ 32 mm.The device used during the aforementioned procedure was implanted in an aortic neck measuring 17-18 mm.The (b)(4) ifu for the gore® excluder® aaa endoprosthesis states: ¿if multiple cannulation attempts fail, the trunk-ipsilateral leg endoprosthesis may be repositioned for better contralateral gate access by following steps a through d above.¿ the (b)(4) ifu for the gore® excluder® aaa endoprosthesis provides the following warnings: ¿do not attempt to reposition the endoprosthesis after complete deployment of the device.Vessel damage or device misplacement may result.¿ ¿incorrect deployment or migration of the endoprosthesis may require surgical intervention.¿ ¿always have a vascular surgery team available during implantation or reintervention procedures in the event that conversion to open surgical repair is necessary.¿ the (b)(4) ifu for the gore® excluder® aaa endoprosthesis states: ¿adverse events that may occur and / or require intervention include, but are not limited to: death; endoprosthesis: incomplete component deployment; occlusion; renal (e.G., artery occlusion, contrast toxicity, insufficiency, failure); surgical conversion.¿.
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The explant evaluation showed the following observations: submitted unfixed was one gore® excluder® aaa endoprosthesis; a trunk-ipsilateral leg endoprosthesis (trunk).The lumen of the trunk body and ipsilateral leg were widely patent.The contralateral gate portion of the device was not expanded (lumen remained closed) from the level of the bifurcation through the distal cuff.The luminal and abluminal device surfaces were generally devoid of tissue except for scattered plaques of friable red/brown material consistent with dried blood.There were multiple longitudinal cuts on the device through the graft material and wire, and the constraint sleeve is missing.These material disruptions are consistent with handling by surgical instrumentation during the explant procedure.Histopathological examination was not performed due to the paucity of adherent tissue.The device was placed in a warm (37°c) saline bath for approximately five minutes and the gate remained closed.The device was then subjected to an enzymatic digestion process to remove biologic debris.Following digestion the device was examined for material disruptions with the aid of a stereomicroscope and scanning electron microscopy.During enzyme digestion the contralateral gate expanded/ opened.Strands of thin translucent to opaque white material were seen spanning across the lumen of the gate.The strands appeared to be attached to the surface of the luminal eptfe.Multiple plaques of shiny material were noted on the luminal surface of the graft.Sem revealed smooth, flat thin layers of material on the luminal surface of the graft which appeared to be adhered to the surface, in multiple configurations, of the expanded-polytetrafluoroethylene (eptfe).A combination of eds, ¿hot stage¿ microscopy and fourier transform infrared spectroscopy identified that the shiny material contained fluorinated ethylene propylene (fep); a copolymer used in the manufacturing of this device.The impact of the presence of this material in the lumen of the device is unknown.Several factors are involved in this case: an unanticipated material was present in the lumen of the device, the device was deployed in anatomical conditions outside the ifu (23mm device is intended for 19-21mm aortic vessel diameter; patients¿ vessel diameter reported to be 17x15mm), and autopsy was not performed immediately, leaving the device in a small vessel diameter and presumed temperatures below 37°c (ideal temperature for nitinol wire prescribed diameter expansion), for an extended period.Considering these factors, in conjunction with the observation that this device did not expand until subjected to conditions of no physical constraint in an agitated 37°c enzyme digestion solution, any combination of these factors could attribute to difficulties expanding/ opening the contralateral gate of the gore® excluder® aaa endoprosthesis.The exact cause of the contralateral gate not expanding could not be determined.No wear related disruptions were identified.Procedural and post-procedure imaging, medical records and autopsy reports were not made available for investigation.Based on gore¿s investigation and information made available, this is a unique event and the exact cause of the contralateral gate not expanding could not be determined.The (b)(4) instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states that the gore® excluder® aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease and who have appropriate anatomy, including an infrarenal aortic neck treatment diameter range of 19 ¿ 32 mm.The device used during the aforementioned procedure was implanted in an aortic neck measuring 17-18 mm.The (b)(4) ifu for the gore® excluder® aaa endoprosthesis states: ¿if multiple cannulation attempts fail, the trunk-ipsilateral leg endoprosthesis may be repositioned for better contralateral gate access by following steps a through d above.¿ the (b)(4) ifu for the gore® excluder® aaa endoprosthesis provides the following warnings: ¿do not attempt to reposition the endoprosthesis after complete deployment of the device.Vessel damage or device misplacement may result.¿ ¿incorrect deployment or migration of the endoprosthesis may require surgical intervention.¿ ¿always have a vascular surgery team available during implantation or reintervention procedures in the event that conversion to open surgical repair is necessary.¿ the (b)(4) ifu for the gore® excluder® aaa endoprosthesis states: ¿adverse events that may occur and / or require intervention include, but are not limited to: death; endoprosthesis: incomplete component deployment; occlusion; renal (e.G., artery occlusion, contrast toxicity, insufficiency, failure); surgical conversion.¿.
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