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WILLIAM A. COOK AUSTRALIA, PTY LTD UNKNOWN; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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| Catalog Number UNKNOWN |
| Device Problem
Insufficient Information (3190)
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| Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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Complaint information came from review of literature article: 'two-year results on real-world fenestrated or branched endovascular repair for complex aortic abdominal aneurysm in france.' stéphan haulon et al doi: https://doi.Org/10.1177/15266028231208653 date of events not known - article covers events from april 2012 to dec 2018.Article covers procedures performed across 15 sites in france.First published online october 30, 2023 complaint devices are either: ce-marked zenith fenestrated aaa endovascular graft (zfen) or branched and/or fenestrated custom-made device (cmd) manufactured by cook medical (william a.Cook australia, brisbane, australia) device: snds database clinical study custom-made device (cook medical).80.7% (866) 96.2% (179) <0.01 zenith fenestrated (cook medical, ce-marked).19.3% (207) 3.8% (7) although the likelihood of the complaint devices being z-fen grafts registered for sale in the usa is far lower than the likelihood of them being cmd's that are not registered for sale in the usa, this is being reported to fda out of an abundance of caution.Note: note: given that multiple papers can be addressing the same cohort of patients, duplicates of the data may be reported and therefore these numbers can be overestimating the events.Cgi01 11 april 2024.
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Event Description
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Haulon s.Et al 2023.Two-year results on real-world fenestrated or branched endovascular repair for complex aortic abdominal aneurysm in france france ¿ april 2012 to dec 2018 fbevar for the treatment of aortic aneurysms: patients received custom-made fenestrated or branched devices (snds: 80.7%, clinical: 96.2%) or ce-marked zenith fenestrated devices (snds: 19.3%, clinical: 3.8%).Ce-marked zenith fenestrated aaa endovascular graft (zfen) or a branched and/or fenestrated custom-made device (cmd) manufactured by cook medical (william a.Cook australia, brisbane, australia) device: snds database clinical study custom-made device (cook medical).80.7% (866) 96.2% (179) <0.01 zenith fenestrated (cook medical, ce-marked).19.3% (207) 3.8% (7) high-risk patient criteria included age =80 years, presence of coronary artery disease, cardiac insufficiency, previous thoracotomy, chronic obstructive pulmonary disease (copd), or chronic terminal renal insufficiency.Data collected included information from the implantation stay and/or during hospital stays throughout follow-up.Data related to the patient¿s smoking history was limited to events directly related to a hospital stay (based on the icd- 10 diagnosis code) or nicotine substitute reimbursements.Information such as adverse events (defined as conversion to open surgical repair, revascularization procedures, complications of vascular prosthesis, non-vascular access site complications, aneurysm rupture, renal failure with or without dialysis, myocardial infarction, stroke, paraplegia or paraparesis, bowel vascular disorders, and dialysis), reason for hospitalization (ie, principal diagnosis), date of death, and medical cause of death (when available) were identified when available.Initial success was defined as no death, no surgical conversion procedures, or no complications involving the vascular prosthesis, grafts, and implants.Chronic terminal renal insufficiency was defined as a patient who required chronic dialysis or renal transplantation, or who had a follow-up visit after renal transplantation captured in the database.Data derived from imaging (eg, patency, aneurysm size, and sac stability) or exact details on all secondary interventions were not captured.However, secondary procedures performed to restore patency of the main graft, limb, components, or extensions were available as part of the snds data set.These included procedures such as dilation, recanalization, thrombectomies, thromboendarterectomies, and bypass procedures, among others.Thus, this information was used as a surrogate measure for secondary interventions for the snds study and will be referred to as secondary interventions for this study henceforth.Mortality data were collected using the date of death available in sniiram and the medical causes of death available in cépidc, when available ((b)(6), 2012 until (b)(6) 2016).Aneurysm related hospital mortality was determined through the identification of hospital stays ending with death and with a principal diagnosis of aneurysm; however, it is possible that not all aneurysm-related deaths were identified as such due to coding limitations and potential out-of-hospital aneurysm-related deaths not identifiable in the snds database.Clinical study design and definitions the clinical study was designed as a prospective, observational, and monitored study in france to evaluate the long-term safety and performance of fenestrated or branched stent grafts for the treatment of patients with complex aaas.The study was conducted for the continued reimbursement registration of abdominal stent grafts per has.Inclusion and exclusion criteria were minimal to reflect real-world use while balancing necessary data quality.Patients were included if they needed endovascular repair of abdominal aortic or aorto-iliac aneurysms morphologically suitable for placement of fenestrated or branched devices and if they did not object to the collection and transmission of their data.Patients were excluded from the study if clinical follow-up was impossible¿for example, patients living abroad and unavailable for follow-up.Because of these limited inclusion and exclusion criteria, collected data were defined as ¿real world,¿ that is observational health data collected on a medical product during standard of care use.Enrollment began in january 2017 and was completed by october 2018 at 15 sites; patients were enrolled consecutively.The study was conducted following local regulations and the ethical principles originating from the declaration of helsinki; the french data protection agency approved the study.Clinical assessments were performed per standard of care.Aneurysm-related mortality was defined as death from aneurysm rupture; death from any cause occurring within 30 days of the initial procedure or a secondary intervention; or any death determined to be related to the aneurysm or its treatment (ie, device or procedure).Death relatedness to the aneurysm, device, and/or procedure was site-reported.Technical success was defined as successful access to the aneurysm site and deployment of the fenestrated or branched graft in the intended location, with all device components patent at deployment completion (per intraoperative angiography).Patency calculations were performed per definitions from oderich et al,16 and only visceral vessels in which stents were placed at procedure and patent upon completion were included in patency calculations (non-targeted vessels were excluded from calculations).Maximum aneurysm diameter was measured from outer wall to outer wall, and aneurysm growth was defined as >5 mm change from baseline measurement (defined as first follow-up imaging after the procedure but before 1-year follow-up).Data analysis all clinical study data were managed by a centralized data coordinating center [details omitted for double-anonymized review].Statistical analyses were performed using sas (version 9.4; sas institute, cary, north carolina) for windows.Unless noted otherwise, continuous variables were reported as mean±standard deviation; categorical variables were reported as percentages and frequencies.Kaplan- meier (km) analysis was used to estimate freedom from all-cause mortality, aneurysm-related mortality, secondary intervention, and loss of target vessel patency.Chi-squared test was used to assess significant differences between the database and clinical study populations.Comparison of snds database study to clinical study patient populations.A total of 1073 patients were included in the analysis of the snds database, a total of 74.3% (797/1073) patients presented with at least 1 high-risk factor.A total of 63.2% (678/1073) patients had their procedure performed at a center with more than 10 implantations per year; all french sites (public and private, low and high volume) with reimbursed zfen or cmd implantations were included in the database study by design.The mean follow-up for these patients was 3.2 years.In the clinical study, aneurysms were reported as juxtarenal (48.9%, 91/186), type iv taaa (23.1%, 43), pararenal (15.1%, 28), or other (12.9%, 24).Additionally, 1 emergent case was site-reported in this study for a patient who presented with juxtarenal aneurysm and impending renal aneurysm rupture.The mean follow-up for these patients was 1.7±0.6 years.There were significant differences found between the 2 study demographics.These included the rate of hypertension, tobacco use in the last 10 years, hyperlipidemia, renal insufficiency, and type of device placed.Technical success initial success was 94.4% (1013/1073) for the snds database study.Clinical study technical success was 97.8% (182/186) with 4 patients experiencing technical failures.The right renal stent was not implanted in 1 patient following difficulties in catheterizing the right renal artery.This patient died 3 days post-procedure of multi-organ failure.In the second patient, iliac artery stenosis prevented the insertion of the device; no target devices were deployed, and the patient died 2 days post-procedure.A celiac stent was not implanted in a third patient because of difficulties with patient anatomy; the celiac artery was instead embolized.Finally, it was impossible to deploy a stent through a celiac artery fenestration in a fourth patient; however, there was no evidence of endoleak upon procedure completion and the vessel was patent upon follow-up.All-cause and aneurysm-related mortality the snds database study reported a 30-day mortality rate of 5.5% (56/1017); 30-day all-cause mortality for the clinical study was 4.3% (8/186).In the database study, km estimates for all-cause similarly, the km estimate for 2-year all-cause survival in the clinical study was 85.1%±2.7%.Kaplan-meier estimate for aneurysm-related survival probability at 2 years was 93.8% based on the health care database, while 2-year aneurysm-related survival was 94.6%±1.7% in the clinical study survival at 2 years was 80.0%.Clinical study deaths within first 30 days from procedure: days post-procedure cause of death site-determined relatedness 1 multi-organ dysfunction related to disease and procedure 2 hemorrhagic shock, acute renal failure related to disease, device, and procedure 2 multi-organ failure related to disease and procedure 4 multi-organ failure related to disease and procedure 13 cerebrovascular accident related to procedure 15 pulmonary failure related to procedure 20 aortic arch rupture not related per site assessment 23 multi-organ failure related to disease and procedure all deaths within the first 30 days were captured in the aneurysm-related mortality calculation, per the study definition, even if the site did not determine that the death was related to disease, procedure, or device.In the clinical study, 10 aneurysm-related deaths were reported, including the 8 deaths within 30 days of the procedure (categorized as aneurysm-related by study definition, regardless of reported relatedness) and 2 additional deaths after the first 30 days.Of these 2 patients who died after 30 days post-procedure, 1 patient died 63 days post-procedure of deterioration following transfemoral amputation related to post-procedural paraplegia; this death was site-reported as related to the study aneurysm, procedure, and device.The second patient with an aneurysm- related death died 131 days post-procedure of chronic respiratory insufficiency.This patient underwent a secondary intervention for a new aortic dissection on post-procedure day 112 with the placement of a thoracic graft; however, this secondary intervention was reported as unsuccessful by the site and the patient experienced respiratory related adverse events prior to death.Adverse events and interventions within 30 days, secondary intervention procedures were noted for 15.6% (167/1073) of patients included in the snds database and dialysis for 1.6% (17/1073) of these patients.Freedom from secondary interventions at 2 years for the snds database population was 73%±2.84%.Thirty-day stroke rate and aneurysm rupture were 0.2% (2/1073) and 0.8%, respectively.Thirty-day total adverse event rate, defined earlier, was 34.3% (368/1073).Two patients in this database study underwent conversion to open surgical repair between 1- and 2-year follow-up; no conversions occurred within 30 days.The clinical study contained more details on exact secondary procedures km freedom from secondary intervention was calculated at 79.1%±3.2% at 2 years.The renal failure rate for this study was 8.1% (15/186) at 30 days.The 30-day stroke rate and aneurysm rupture were 1.6% (3/186) and 0.5% (1/186), respectively.One patient (0.5%, 1/186) underwent conversion to open surgical repair on day 654 post-procedure.This patient experienced repeated right renal thrombosis despite successful secondary interventions, including thrombectomy, thromboaspiration, thrombolysis, additional stent placement, and balloon angioplasty.Imaging outcomes no imaging outcomes were available in the snds database.Thus, we were unable to evaluate endoleaks, aneurysm growth, and target vessel patency in this population.This level of imaging information detail was available in the clinical study.Device migration was noted in 1 patient in the clinical study (0.5%, 1/186) through 2-year follow-up.For this patient, cranial migration of the left and right iliac leg grafts was observed at a 2-year follow-up, and issues concerning this migration were successfully resolved following the endovascular placement of bilateral iliac extensions.Eleven patients in the clinical study had type i [5 patients] or iii endoleaks [6 patinets] upon procedural completion angiogram, neither of the proximal type i endoleaks at the procedure was treated, but 2 of the distal type i endoleaks were treated with distal extensions.Of the 6 type iii endoleaks observed at the procedure, 2were treated successfully (1 via additional stent placement, no additional details were provided for the second patient).Overall, through 2 years, 17 endoleaks were associated with secondary interventions in 15 patients, and all associated interventions were reported as successful.For patients with eligible imaging in the clinical study, the overall maximum aneurysm size decreased from a mean diameter of 56.0±11.9 mm at 1 year to 52.5±13.8 mm at 2 years.Aneurysm shrinkage or stability was observed in 88.2% (75/85) of patients with eligible imaging at 1 year, and in 92.3% (72/78) of eligible patients at 2 years.Of the 10 patients with aneurysm growth at 1 year, 5 patients had endoleaks detected at the same visit: 1 patient had a distal type i endoleak, 2 patients had type ii endoleaks, and 2 patients had type iii endoleaks.At 2 years, aneurysm growth was observed in 6 patients; 3 of these patients had endoleaks detected at the same visit.Freedom from loss of primary patency was 96.4%±2.3%, 95.9%±2.0%, 95.7%±2.0%, and 99.1%±1.0% for the celiac, sma, right renal, and left renal artery, respectively, at 2 years.Primary-assisted and secondary patency were not established for any target vessels in any patients based on reported data.Because of the overlap in years of clinical study enrollment and data extraction from the database, it is possible that some patients in the french clinical study are also captured in the french database.Therefore, comparisons between the 2 studies should highlight the methodology of data capture because of the limitations of potential data interdependence.Loss of primary patency: = 30 days +30 days = 2 years celiac artery 1 7 sma 0 9 right renal artery 0 18 left renal artery 0 1 one instance of bilateral iliac leg migration was observed in the french clinical study, but successful treatment with iliac leg extensions was performed and no changes in aneurysm sac size were observed for this patient.No additional device integrity issues were reported.Through 2 years, 17 endoleaks were treated successfully in the clinical study, thereby suggesting the importance of surveillance detection following fbevar.23.Complaints registered as: this (b)(4): procedural related difficulties/technical failure 2 patients: the right renal stent was not implanted in 1 patient following difficulties in catheterizing the right renal artery.This patient died 3 days post-procedure of multi-organ failure.(patient's death reported under (b)(4)) in one patient it was impossible to deploy a stent through a celiac artery fenestration in a fourth patient; however, there was no evidence of endoleak upon procedure completion and the vessel was patent upon follow-up.(b)(4): adverse physiological response leading to mortality within 30 days of the procedure in 5 patients haulon et al 2023: clinical study deaths within first 30 days from procedure: multi organ failure in 3 patients, multi organ dysfunction in one patient and aortic graft rupture in one patient.(b)(4): procedural complications leading to death within 30 days in 2 patients haulon et al 2023.Hemorrhagic shock in one patient and cerebrovascular accident in the other patient.(b)(4): renal failure leading to death within 30 days in 1 patient haulon et al 2023.2 days post procedure the patient experienced acute renal failure.(b)(4): paraplegia leading to additional procedure and death later than 30 days post procedure haulon et al 2023.One patient died 63 days post-procedure of deterioration following transfemoral amputation related to post-procedural paraplegia; this death was site-reported as related to the study aneurysm, procedure, and device.(b)(4): dissection leading to death later than 30 days post procedure in 1 patient haulon et al 2023.One patient with an aneurysm- related death died 131 days post-procedure of chronic respiratory insufficiency.This patient underwent a secondary intervention for a new aortic dissection on post-procedure day 112 with the placement of a thoracic graft; however, this secondary intervention was reported as unsuccessful by the site and the patient experienced respiratory related adverse events prior to death.(b)(4): renal failure within 30 days post procedure in 15 patients haulon et al 2023.The renal failure rate for this study was 8.1% (15/186) at 30 days.(b)(4) stroke within 30 days post procedure in 3 patients haulon et al 2023.The 30-day stroke rate: the stroke rate was given as both 1.6% (3/186) and 0.2% (2/1073) throughout the article.A quantity of 3 will be used to err on the side of caution.(b)(4): secondary intervention within 30 days for 167 patients haulon et al 2023.Within 30 days, secondary intervention procedures were noted for 15.6% (167/1073) of patients included in the snds database.Dialysis for 1.6% (17/1073) of these patients (b)(4): conversion to open repair between 1- and 2-year post procedure in 1 patient haulon et al 2023.Patient in this database study underwent conversion to open surgical repair between 1- and 2-year follow-up; (no conversions occurred within 30 days).Freedom from secondary intervention was calculated at 79.1%±3.2% at 2 years.(b)(4) thrombus in one patient requiring repeated interventions including conversion to open repair in 1 patient haulon et al 2023.One patient (0.5%, 1/186) underwent conversion to open surgical repair on day 654 post-procedure.This patient experienced repeated right renal thrombosis despite successful secondary interventions, including thrombectomy, thromboaspiration, thrombolysis, additional stent placement, and balloon angioplasty.(b)(4): device migration of the left and right iliac leg grafts in 1 patient requiring intervention haulon et al 2023.Device migration was noted in 1 patient in the clinical study (0.5%, 1/186) through 2-year follow-up.For this patient, cranial migration of the left and right iliac leg grafts was observed at a 2-year follow-up, and issues concerning this migration were successfully resolved following the endovascular placement of bilateral iliac extensions.(b)(4): proximal type 1 endoleaks seen on completion angiogram in 2 patients haulon et al 2023.Proximal type 1 endoleaks seen on completion angiogram in 2 patients.Neither of the proximal type i endoleaks at the procedure were treated.(b)(4) type iii endoleaks upon procedural completion angiogram in 6 patients haulon et al 2023.Type iii endoleaks seen in 6 patients upon procedural completion angiogram.2 were treated successfully: 1 via additional stent placement, no additional details were provided for the second patient treated successfully.No details supplied for the other 4 patients.(b)(4): secondary interventions for endoleaks in 8 patients haulon et al 2023.Of the 15 patients¿ secondary intervention for endoleaks, 7 have either been registered under another pr or are not associated with cook manufactured devices; therefore, the total number for this pr is 8.(b)(4): type iii endoleaks seen at 1 year in 2 patients haulon et al 2023.Type iii endoleaks seen at 1 year in 2 patients.(b)(4): loss of primary patency for 36 patients in total haulon et al 2023.Loss of primary patency in celiac artery within 30 days for one patient.Loss of primary patency between 30 days & 2 years for 35 patients.
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Manufacturer Narrative
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No part of the device was returned for evaluation; therefore, no visual inspection or functional testing could be performed.No imaging was received to assist the investigation.Additional information was requested, but despite several requests, no response was received.Due to the lot number of the device not being provided, a review of the device history record consisting of the relevant work order was not able to be conducted.Review of specifications found that there are a number of controls and processes in place that would identify faulty product prior to shipping.As the lot number is unknown, the instructions for use (ifu) currently supplied with zfen devices for general information was reviewed, and found to contain appropriate warnings, precautions, and instructions to the user, including: 5 potential adverse events clinical studies have identified that with use of the zenith fenestrated aaa endovascular graft there is a risk of renal impairment/loss (which could lead to a need for dialysis).Clinical studies have shown that this risk is reduced when the renal arteries are stented as part of the procedure to implant a zenith fenestrated aaa endovascular graft.Stenting of the renal arteries is therefore strongly recommended with use of the zenith fenestrated aaa endovascular graft to reduce the risk of renal impairment/loss.Other adverse events that may occur and/or require intervention include, but are not limited to: ¿ endoleak ¿ renal complications and subsequent attendant problems (e.G., artery occlusion, contrast toxicity, insufficiency, failure) 11 imaging guidelines and post-operative follow-up 11.1 general the long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires life long, regular follow-up to assess their health and performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive additional follow-up.There is no evidence to suggest that the user did not follow the instructions for use.Based on the information provided, a definitive root cause for the events could not be determined.The appropriate individuals will continue to monitor for similar complaints.The mandatory requirement to always check complaints history during a complaint investigation will ensure trends are constantly monitored.After considering this event the benefits of using this device still outweigh the known risks.Complaint information came from review of literature article: 'two-year results on real-world fenestrated or branched endovascular repair for complex aortic abdominal aneurysm in france.' stéphan haulon et al doi: https://doi.Org/10.1177/15266028231208653.Date of events not known - article covers events from april 2012 to dec 2018.Article covers procedures performed across 15 sites in france.First published online october 30, 2023 complaint devices are either: ce-marked zenith fenestrated aaa endovascular graft (zfen) or branched and/or fenestrated custom-made device (cmd) manufactured by cook medical (william a.Cook (b)(6), australia) device: snds database clinical study custom-made device (cook medical).80.7% (866) 96.2% (179) <0.01 zenith fenestrated (cook medical, ce-marked).19.3% (207) 3.8% (7) although the likelihood of the complaint devices being z-fen grafts registered for sale in the usa is far lower than the likelihood of them being cmd's that are not registered for sale in the usa, this is being reported to fda out of an abundance of caution.Note: note: given that multiple papers can be addressing the same cohort of patients, duplicates of the data may be reported and therefore these numbers can be overestimating the events.
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Event Description
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Haulon s.Et al 2023.Two-year results on real-world fenestrated or branched endovascular repair for complex aortic abdominal aneurysm in france.France ¿ april 2012 to dec 2018 fbevar for the treatment of aortic aneurysms: patients received custom-made fenestrated or branched devices (snds: 80.7%, clinical: 96.2%) or ce-marked zenith fenestrated devices (snds: 19.3%, clinical: 3.8%).Ce-marked zenith fenestrated aaa endovascular graft (zfen) or a branched and/or fenestrated custom-made device (cmd) manufactured by cook medical (william a.Cook australia, brisbane, australia).Device: snds database clinical study custom-made device (cook medical).80.7% (866) 96.2% (179) <0.01 zenith fenestrated (cook medical, ce-marked).19.3% (207) 3.8% (7) high-risk patient criteria included age =80 years, presence of coronary artery disease, cardiac insufficiency, previous thoracotomy, chronic obstructive pulmonary disease (copd), or chronic terminal renal insufficiency.Data collected included information from the implantation stay and/or during hospital stays throughout follow-up.Data related to the patient¿s smoking history was limited to events directly related to a hospital stay (based on the icd- 10 diagnosis code) or nicotine substitute reimbursements.Information such as adverse events (defined as conversion to open surgical repair, revascularization procedures, complications of vascular prosthesis, non-vascular access site complications, aneurysm rupture, renal failure with or without dialysis, myocardial infarction, stroke, paraplegia or paraparesis, bowel vascular disorders, and dialysis), reason for hospitalization (ie, principal diagnosis), date of death, and medical cause of death (when available) were identified when available.Initial success was defined as no death, no surgical conversion procedures, or no complications involving the vascular prosthesis, grafts, and implants.Chronic terminal renal insufficiency was defined as a patient who required chronic dialysis or renal transplantation, or who had a follow-up visit after renal transplantation captured in the database.Data derived from imaging (eg, patency, aneurysm size, and sac stability) or exact details on all secondary interventions were not captured.However, secondary procedures performed to restore patency of the main graft, limb, components, or extensions were available as part of the snds data set.These included procedures such as dilation, recanalization, thrombectomies, thromboendarterectomies, and bypass procedures, among others.Thus, this information was used as a surrogate measure for secondary interventions for the snds study and will be referred to as secondary interventions for this study henceforth.Mortality data were collected using the date of death available in sniiram and the medical causes of death available in cépidc, when available (january 1, 2012 until december 31, 2016).Aneurysm related hospital mortality was determined through the identification of hospital stays ending with death and with a principal diagnosis of aneurysm; however, it is possible that not all aneurysm-related deaths were identified as such due to coding limitations and potential out-of-hospital aneurysm-related deaths not identifiable in the snds database.Clinical study design and definitions the clinical study was designed as a prospective, observational, and monitored study in france to evaluate the long-term safety and performance of fenestrated or branched stent grafts for the treatment of patients with complex aaas.The study was conducted for the continued reimbursement registration of abdominal stent grafts per has.Inclusion and exclusion criteria were minimal to reflect real-world use while balancing necessary data quality.Patients were included if they needed endovascular repair of abdominal aortic or aorto-iliac aneurysms morphologically suitable for placement of fenestrated or branched devices and if they did not object to the collection and transmission of their data.Patients were excluded from the study if clinical follow-up was impossible¿for example, patients living abroad and unavailable for follow-up.Because of these limited inclusion and exclusion criteria, collected data were defined as ¿real world,¿ that is observational health data collected on a medical product during standard of care use.Enrollment began in january 2017 and was completed by october 2018 at 15 sites; patients were enrolled consecutively.The study was conducted following local regulations and the ethical principles originating from the declaration of helsinki; the french data protection agency approved the study.Clinical assessments were performed per standard of care.Aneurysm-related mortality was defined as death from aneurysm rupture; death from any cause occurring within 30 days of the initial procedure or a secondary intervention; or any death determined to be related to the aneurysm or its treatment (ie, device or procedure).Death relatedness to the aneurysm, device, and/or procedure was site-reported.Technical success was defined as successful access to the aneurysm site and deployment of the fenestrated or branched graft in the intended location, with all device components patent at deployment completion (per intraoperative angiography).Patency calculations were performed per definitions from oderich et al,16 and only visceral vessels in which stents were placed at procedure and patent upon completion were included in patency calculations (non-targeted vessels were excluded from calculations).Maximum aneurysm diameter was measured from outer wall to outer wall, and aneurysm growth was defined as >5 mm change from baseline measurement (defined as first follow-up imaging after the procedure but before 1-year follow-up).Data analysis all clinical study data were managed by a centralized data coordinating center [details omitted for double-anonymized review].Statistical analyses were performed using sas (version 9.4; sas institute, cary, north carolina) for windows.Unless noted otherwise, continuous variables were reported as mean±standard deviation; categorical variables were reported as percentages and frequencies.Kaplan- meier (km) analysis was used to estimate freedom from all-cause mortality, aneurysm-related mortality, secondary intervention, and loss of target vessel patency.Chi-squared test was used to assess significant differences between the database and clinical study populations.Comparison of snds database study to clinical study patient populations.A total of 1073 patients were included in the analysis of the snds database, a total of 74.3% (797/1073) patients presented with at least 1 high-risk factor.A total of 63.2% (678/1073) patients had their procedure performed at a center with more than 10 implantations per year; all french sites (public and private, low and high volume) with reimbursed zfen or cmd implantations were included in the database study by design.The mean follow-up for these patients was 3.2 years.In the clinical study, aneurysms were reported as juxtarenal (48.9%, 91/186), type iv taaa (23.1%, 43), pararenal (15.1%, 28), or other (12.9%, 24).Additionally, 1 emergent case was site-reported in this study for a patient who presented with juxtarenal aneurysm and impending renal aneurysm rupture.The mean follow-up for these patients was 1.7±0.6 years.There were significant differences found between the 2 study demographics.These included the rate of hypertension, tobacco use in the last 10 years, hyperlipidemia, renal insufficiency, and type of device placed.Technical success initial success was 94.4% (1013/1073) for the snds database study.Clinical study technical success was 97.8% (182/186) with 4 patients experiencing technical failures.The right renal stent was not implanted in 1 patient following difficulties in catheterizing the right renal artery.This patient died 3 days post-procedure of multi-organ failure.In the second patient, iliac artery stenosis prevented the insertion of the device; no target devices were deployed, and the patient died 2 days post-procedure.A celiac stent was not implanted in a third patient because of difficulties with patient anatomy; the celiac artery was instead embolized.Finally, it was impossible to deploy a stent through a celiac artery fenestration in a fourth patient; however, there was no evidence of endoleak upon procedure completion and the vessel was patent upon follow-up.All-cause and aneurysm-related mortality the snds database study reported a 30-day mortality rate of 5.5% (56/1017); 30-day all-cause mortality for the clinical study was 4.3% (8/186).In the database study, km estimates for all-cause similarly, the km estimate for 2-year all-cause survival in the clinical study was 85.1%±2.7%.Kaplan-meier estimate for aneurysm-related survival probability at 2 years was 93.8% based on the health care database, while 2-year aneurysm-related survival was 94.6%±1.7% in the clinical study survival at 2 years was 80.0%.Clinical study deaths within first 30 days from procedure: days post-procedure cause of death site-determined relatedness 1 multi-organ dysfunction related to disease and procedure 2 hemorrhagic shock, acute renal failure related to disease, device, and procedure 2 multi-organ failure related to disease and procedure 4 multi-organ failure related to disease and procedure 13 cerebrovascular accident related to procedure 15 pulmonary failure related to procedure 20 aortic arch rupture not related per site assessment 23 multi-organ failure related to disease and procedure all deaths within the first 30 days were captured in the aneurysm-related mortality calculation, per the study definition, even if the site did not determine that the death was related to disease, procedure, or device.In the clinical study, 10 aneurysm-related deaths were reported, including the 8 deaths within 30 days of the procedure (categorized as aneurysm-related by study definition, regardless of reported relatedness) and 2 additional deaths after the first 30 days.Of these 2 patients who died after 30 days post-procedure, 1 patient died 63 days post-procedure of deterioration following transfemoral amputation related to post-procedural paraplegia; this death was site-reported as related to the study aneurysm, procedure, and device.The second patient with an aneurysm- related death died 131 days post-procedure of chronic respiratory insufficiency.This patient underwent a secondary intervention for a new aortic dissection on post-procedure day 112 with the placement of a thoracic graft; however, this secondary intervention was reported as unsuccessful by the site and the patient experienced respiratory related adverse events prior to death.Adverse events and interventions within 30 days, secondary intervention procedures were noted for 15.6% (167/1073) of patients included in the snds database and dialysis for 1.6% (17/1073) of these patients.Freedom from secondary interventions at 2 years for the snds database population was 73%±2.84%.Thirty-day stroke rate and aneurysm rupture were 0.2% (2/1073) and 0.8%, respectively.Thirty-day total adverse event rate, defined earlier, was 34.3% (368/1073).Two patients in this database study underwent conversion to open surgical repair between 1- and 2-year follow-up; no conversions occurred within 30 days.The clinical study contained more details on exact secondary procedures km freedom from secondary intervention was calculated at 79.1%±3.2% at 2 years.The renal failure rate for this study was 8.1% (15/186) at 30 days.The 30-day stroke rate and aneurysm rupture were 1.6% (3/186) and 0.5% (1/186), respectively.One patient (0.5%, 1/186) underwent conversion to open surgical repair on day 654 post-procedure.This patient experienced repeated right renal thrombosis despite successful secondary interventions, including thrombectomy, thromboaspiration, thrombolysis, additional stent placement, and balloon angioplasty.Imaging outcomes no imaging outcomes were available in the snds database.Thus, we were unable to evaluate endoleaks, aneurysm growth, and target vessel patency in this population.This level of imaging information detail was available in the clinical study.Device migration was noted in 1 patient in the clinical study (0.5%, 1/186) through 2-year follow-up.For this patient, cranial migration of the left and right iliac leg grafts was observed at a 2-year follow-up, and issues concerning this migration were successfully resolved following the endovascular placement of bilateral iliac extensions.Eleven patients in the clinical study had type i [5 patients] or iii endoleaks [6 patients] upon procedural completion angiogram, neither of the proximal type i endoleaks at the procedure was treated, but 2 of the distal type i endoleaks were treated with distal extensions.Of the 6 type iii endoleaks observed at the procedure, 2 were treated successfully (1 via additional stent placement, no additional details were provided for the second patient).Overall, through 2 years, 17 endoleaks were associated with secondary interventions in 15 patients, and all associated interventions were reported as successful.For patients with eligible imaging in the clinical study, the overall maximum aneurysm size decreased from a mean diameter of 56.0±11.9 mm at 1 year to 52.5±13.8 mm at 2 years.Aneurysm shrinkage or stability was observed in 88.2% (75/85) of patients with eligible imaging at 1 year, and in 92.3% (72/78) of eligible patients at 2 years.Of the 10 patients with aneurysm growth at 1 year, 5 patients had endoleaks detected at the same visit: 1 patient had a distal type i endoleak, 2 patients had type ii endoleaks, and 2 patients had type iii endoleaks.At 2 years, aneurysm growth was observed in 6 patients; 3 of these patients had endoleaks detected at the same visit.Freedom from loss of primary patency was 96.4%±2.3%, 95.9%±2.0%, 95.7%±2.0%, and 99.1%±1.0% for the celiac, sma, right renal, and left renal artery, respectively, at 2 years.Primary-assisted and secondary patency were not established for any target vessels in any patients based on reported data.Because of the overlap in years of clinical study enrollment and data extraction from the database, it is possible that some patients in the french clinical study are also captured in the french database.Therefore, comparisons between the 2 studies should highlight the methodology of data capture because of the limitations of potential data interdependence.Loss of primary patency: = 30 days +30 days = 2 years celiac artery 1 7 sma 0 9 right renal artery 0 18 left renal artery 0 1 one instance of bilateral iliac leg migration was observed in the french clinical study, but successful treatment with iliac leg extensions was performed and no changes in aneurysm sac size were observed for this patient.No additional device integrity issues were reported.Through 2 years, 17 endoleaks were treated successfully in the clinical study, thereby suggesting the importance of surveillance detection following fbevar.23.Complaints registered as: this (b)(4): procedural related difficulties/technical failure 2 patients: the right renal stent was not implanted in 1 patient following difficulties in catheterizing the right renal artery.This patient died 3 days post-procedure of multi-organ failure.(patient's death reported under (b)(4).In one patient it was impossible to deploy a stent through a celiac artery fenestration in a fourth patient; however, there was no evidence of endoleak upon procedure completion and the vessel was patent upon follow-up.(b)(4): adverse physiological response leading to mortality within 30 days of the procedure in 5 patients haulon et al 2023: clinical study deaths within first 30 days from procedure: multi organ failure in 3 patients, multi organ dysfunction in one patient and aortic graft rupture in one patient.(b)(4): procedural complications leading to death within 30 days in 2 patients haulon et al 2023.Hemorrhagic shock in one patient and cerebrovascular accident in the other patient.(b)(4): renal failure leading to death within 30 days in 1 patient haulon et al 2023.2 days post procedure the patient experienced acute renal failure.(b)(4): paraplegia leading to additional procedure and death later than 30 days post procedure haulon et al 2023.One patient died 63 days post-procedure of deterioration following transfemoral amputation related to post-procedural paraplegia; this death was site-reported as related to the study aneurysm, procedure, and device.(b)(4): dissection leading to death later than 30 days post procedure in 1 patient haulon et al 2023.One patient with an aneurysm- related death died 131 days post-procedure of chronic respiratory insufficiency.This patient underwent a secondary intervention for a new aortic dissection on post-procedure day 112 with the placement of a thoracic graft; however, this secondary intervention was reported as unsuccessful by the site and the patient experienced respiratory related adverse events prior to death.(b)(4): renal failure within 30 days post procedure in 15 patients haulon et al 2023.The renal failure rate for this study was 8.1% (15/186) at 30 days.(b)(4) stroke within 30 days post procedure in 3 patients haulon et al 2023.The 30-day stroke rate: the stroke rate was given as both 1.6% (3/186) and 0.2% (2/1073) throughout the article.A quantity of 3 will be used to err on the side of caution.(b)(4): secondary intervention within 30 days for 167 patients haulon et al 2023.Within 30 days, secondary intervention procedures were noted for 15.6% (167/1073) of patients included in the snds database.Dialysis for 1.6% (17/1073) of these patients.(b)(4): conversion to open repair between 1- and 2-year post procedure in 1 patient haulon et al 2023.Patient in this database study underwent conversion to open surgical repair between 1- and 2-year follow-up; (no conversions occurred within 30 days).Freedom from secondary intervention was calculated at 79.1%±3.2% at 2 years.(b)(4) thrombus in one patient requiring repeated interventions including conversion to open repair in 1 patient haulon et al 2023.One patient (0.5%, 1/186) underwent conversion to open surgical repair on day 654 post-procedure.This patient experienced repeated right renal thrombosis despite successful secondary interventions, including thrombectomy, thromboaspiration, thrombolysis, additional stent placement, and balloon angioplasty.(b)(4): device migration of the left and right iliac leg grafts in 1 patient requiring intervention haulon et al 2023.Device migration was noted in 1 patient in the clinical study (0.5%, 1/186) through 2-year follow-up.For this patient, cranial migration of the left and right iliac leg grafts was observed at a 2-year follow-up, and issues concerning this migration were successfully resolved following the endovascular placement of bilateral iliac extensions.(b)(4): proximal type 1 endoleaks seen on completion angiogram in 2 patients haulon et al 2023.Proximal type 1 endoleaks seen on completion angiogram in 2 patients.Neither of the proximal type i endoleaks at the procedure were treated.(b)(4): type iii endoleaks upon procedural completion angiogram in 6 patients haulon et al 2023.Type iii endoleaks seen in 6 patients upon procedural completion angiogram.2 were treated successfully: 1 via additional stent placement, no additional details were provided for the second patient treated successfully.No details supplied for the other 4 patients.(b)(4): secondary interventions for endoleaks in 8 patients haulon et al 2023.Of the 15 patients¿ secondary intervention for endoleaks, 7 have either been registered under another pr or are not associated with cook manufactured devices; therefore, the total number for this pr is 8.(b)(4): type iii endoleaks seen at 1 year in 2 patients haulon et al 2023.Type iii endoleaks seen at 1 year in 2 patients.(b)(4): loss of primary patency for 36 patients in total haulon et al 2023.Loss of primary patency in celiac artery within 30 days for one patient.Loss of primary patency between 30 days & 2 years for 35 patients.
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