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WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED GRAFT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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| Catalog Number UNKNOWN |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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| Patient Problems
Cardiac Arrest (1762); Pneumonia (2011); Obstruction/Occlusion (2422); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
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Event Type
Injury
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Event Description
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All patients that underwent fevar over a 2-year period, from 2013 to 2015, were included was performed.All patients in this series underwent fevar using the food and drug administration (fda) approved zenith fenestrated aaa endovascular graft (zfen), custom-made devices (cmds), or the investigational off-the-shelf p-branch fenestrated endograft.Indications included type iv thoracoabdominal, suprarenal, and juxtarenal aortic aneurysms, type ia endoleaks after previous evar, and penetrating atherosclerotic ulcerations.Demographics and comorbidities were evaluated for each gender group, including procedural data and imaging.Aneurysm classification was based on the recommended reporting standards for aneurysm repair of the society for vascular surgery.A juxtarenal aortic aneurysm is defined as an aneurysm with an infrarenal aortic neck of less than 10 mm with involvement of the aneurysmal dilatation up to the level of the renal arteries, which originate from normal aorta.Suprarenal aortic aneurysm involves the origin of at least one renal artery but do not extend into the celiac artery.Type iv thoracoabdominal aortic aneurysms involve the origin of all four visceral arteries, including the celiac axis, extending up to the diaphragmatic hiatus.Postprocedural events were defined as those within the first 30 days after the procedure.Outcomes were compared between males and females that underwent fevar.End points.The primary end point was the rate of major adverse events (maes) within 30 days after the target procedure.Maes were defined as the presence of one of the following: all-cause mortality, bowel ischemia (requiring intensification of medical therapy or surgical therapy), myocardial infarction (raised levels of cardiac biomarkers or electrocardiogram changes), paraplegia, respiratory failure (pneumonia or respiratory failure requiring ventilatory support for >24 hours), stroke, and renal failure requiring dialysis.Secondary end points included any perioperative complication, estimated blood loss, length of hospital stay, intensive care unit (icu) duration of stay, days to ambulate, days to start oral intake, rate of endoleak, procedure-related reinterventions, and renal adverse events defined as renal function deterioration with a 30% or greater increase of serum creatinine from baseline.Variations on the estimated glomerular filtration rate (egfr) from baseline according to gender were analyzed as well.A total of 79 patients underwent fevar, 63 men (80%) and 16 women (20%), with a median age of 73 years (interquartile range [iqr], 68-79 years).The zenith fenestrated aaa endograft was used in 60 patients (76%), zenith p-branch in 6 patients (8%), and investigational cmds in 13 patients (16%).Aneurysm anatomic location included 19 juxtarenal aneurysms (24%), 53 suprarenal aneurysms (67%), and 7 type iv thoracoabdominal aneurysms (9%).Median aneurysm size was 55 mm (iqr, 53-62 mm).Of the patients, 95% were asymptomatic at the time of repair.The median number of fenestrations was three.Men were more likely to have history of coronary artery disease (65% vs 19%; p =.01) and have higher values of preoperative creatinine (1.2 [iqr, 0.1-1.4] vs 0.9 [iqr, 0.7-1.3] among females; p <.02).Women were more likely to undergo endoconduits at the access site before the target procedure (19% vs 2% of men; p =.02).Anatomically, women had smaller diameters of the celiac artery (p =.003), superior mesenteric artery (p <.01), right renal (p <.01) and left renal arteries (p =.05), and common femoral arteries (right common femoral artery, p <.01; left common femoral artery, p =.05).No 30-day deaths occurred.The overall postoperative complication rate was similar among females and males (31% vs 33%; p >.5).However, women experienced longer times in the icu with a median of icu stay of 3 days (iqr, 2-5 days) vs 2 days (iqr 1-3 days; p =.05) in males.Similarly, the median duration of hospital stay was longer among women at 4.5 days (iqr, 3-6.5 days) vs 3 days (iqr, 2-4 days; p <.01).The median estimated blood loss among women was 600 ml (iqr, 400-1000 ml) vs 500 ml (iqr, 200-600 ml) in men (p =.05).After multivariate analysis and adjustment of all independent predictors, female gender was associated with an eight-fold increased risk of renal function deterioration (odds ratio, 8.13; 95% confidence interval, 6.14-10.75).After logistic regression analysis, women were found to have an odds ratio of 7.36 (95% confidence interval, 6.68-8.11).In our study, access vessels were smaller in women and one-fifth of our female population required the use of endoconduits before fenestrated repair.This (b)(4): this pr covers 7 cases of major adverse events as defined in the article.One male patient developed a non-st myocardial infarction treated with antiplatelet therapy and observation.One female patient with an exacerbation of heart failure that resolved with medical therapy.Four patients (one woman and three men) diagnosed with pneumonia (one required tracheostomy).One man diagnosed with small bowel obstruction that resolved with conservative medical therapy.
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Manufacturer Narrative
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Timaran de, knowles m, soto-gonzalez m, et al.Gender and perioperative outcomes after fenestrated endovascular repair using custom-made and off-the-shelf devices.J vasc surg.2016;64(2):267-272.Doi:10.1016/j.Jvs.2016.02.062 (b)(4) are related.
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Manufacturer Narrative
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No part of the device was returned for evaluation.Additional information was requested, but no further information was received.No imaging was received to assist the investigation.Manufacturing records review could not be completed as the lot number is unknown.Review of the instructions for use (ifu) likely supplied with the device (as the lot number is unknown, the ifu currently supplied with zfen devices was reviewed) and states: 4.1 general use information the long-term performance of fenestrated endovascular grafts, including the stents placed in fenestrations/scallops, has not yet been established all patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft patients with specific clinical findings (e g , endoleaks, enlarging aneurysms, changes in the structure or position of the endovascular graft, or stenosis/occlusion of vessels accommodated by fenestrations) should receive enhanced follow-up.4.2 patient selection, treatment and follow-up.Inability to maintain patency of at least one internal iliac artery or occlusion of an indispensable inferior mesenteric artery may increase the risk of pelvic/bowel ischemia.5.Adverse events: potential adverse events that may occur and/or require intervention include, but are not limited to: - cardiac complications and subsequent attendant problems (e.G., arrhythmia, myocardial infarction, congestive heart failure, hypotension, hypertension).- pulmonary/respiratory complications and subsequent attendant problems (e.G., pneumonia, respiratory failure, prolonged intubation).- bowel complications (e.G., ileus, transient ischemia, infarction, necrosis).There is no evidence to suggest that the user did not follow the instructions for use.Based on the information received, a definitive root cause for these events could not be determined.This is a known effect of failure, and it is listed in the risk document and in the ifu.Should additional information be received at any time in the future the investigation may be updated, and an additional report may be supplied.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.The event information was taken from a literature article: timaran de, knowles m, soto-gonzalez m, et al.Gender and perioperative outcomes after fenestrated endovascular repair using custom-made and off-the-shelf devices.J vasc surg.2016;64(2):267-272.Doi:10.1016/j.Jvs.2016.02.062.The initial submission covered 7 cases of major adverse events.This had been updated as the investigation required some events to be investigated separately.The events that have been investigated separately are reported under.- (b)(4): one man diagnosed with small bowel obstruction that resolved with conservative medical therapy.The events reported in (b)(4) are related.
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Event Description
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All patients that underwent fevar over a 2-year period, from 2013 to 2015, were included was performed.All patients in this series underwent fevar using the food and drug administration (fda) approved zenith fenestrated aaa endovascular graft (zfen), custom-made devices (cmds), or the investigational off-the-shelf p-branch fenestrated endograft.Indications included type iv thoracoabdominal, suprarenal, and juxtarenal aortic aneurysms, type ia endoleaks after previous evar, and penetrating atherosclerotic ulcerations.Demographics and comorbidities were evaluated for each gender group, including procedural data and imaging.Aneurysm classification was based on the recommended reporting standards for aneurysm repair of the society for vascular surgery.A juxtarenal aortic aneurysm is defined as an aneurysm with an infrarenal aortic neck of less than 10 mm with involvement of the aneurysmal dilatation up to the level of the renal arteries, which originate from normal aorta.Suprarenal aortic aneurysm involves the origin of at least one renal artery but do not extend into the celiac artery.Type iv thoracoabdominal aortic aneurysms involve the origin of all four visceral arteries, including the celiac axis, extending up to the diaphragmatic hiatus.Postprocedural events were defined as those within the first 30 days after the procedure.Outcomes were compared between males and females that underwent fevar.End points.The primary end point was the rate of major adverse events (maes) within 30 days after the target procedure.Maes were defined as the presence of one of the following: all-cause mortality, bowel ischemia (requiring intensification of medical therapy or surgical therapy), myocardial infarction (raised levels of cardiac biomarkers or electrocardiogram changes), paraplegia, respiratory failure (pneumonia or respiratory failure requiring ventilatory support for >24 hours), stroke, and renal failure requiring dialysis.Secondary end points included any perioperative complication, estimated blood loss, length of hospital stay, intensive care unit (icu) duration of stay, days to ambulate, days to start oral intake, rate of endoleak, procedure-related reinterventions, and renal adverse events defined as renal function deterioration with a 30% or greater increase of serum creatinine from baseline.Variations on the estimated glomerular filtration rate (egfr) from baseline according to gender were analyzed as well.A total of 79 patients underwent fevar, 63 men (80%) and 16 women (20%), with a median age of 73 years (interquartile range [iqr], 68-79 years).The zenith fenestrated aaa endograft was used in 60 patients (76%), zenith p-branch in 6 patients (8%), and investigational cmds in 13 patients (16%).Aneurysm anatomic location included 19 juxtarenal aneurysms (24%), 53 suprarenal aneurysms (67%), and 7 type iv thoracoabdominal aneurysms (9%).Median aneurysm size was 55 mm (iqr, 53-62 mm).Of the patients, 95% were asymptomatic at the time of repair.The median number of fenestrations was three.Men were more likely to have history of coronary artery disease (65% vs 19%; p =.01) and have higher values of preoperative creatinine (1.2 [iqr, 0.1-1.4] vs 0.9 [iqr, 0.7-1.3] among females; p <.02).Women were more likely to undergo endoconduits at the access site before the target procedure (19% vs 2% of men; p =.02).Anatomically, women had smaller diameters of the celiac artery (p =.003), superior mesenteric artery (p <.01), right renal (p <.01) and left renal arteries (p =.05), and common femoral arteries (right common femoral artery, p <.01; left common femoral artery, p =.05).No 30-day deaths occurred.The overall postoperative complication rate was similar among females and males (31% vs 33%; p >.5).However, women experienced longer times in the icu with a median of icu stay of 3 days (iqr, 2-5 days) vs 2 days (iqr 1-3 days; p =.05) in males.Similarly, the median duration of hospital stay was longer among women at 4.5 days (iqr, 3-6.5 days) vs 3 days (iqr, 2-4 days; p <.01).The median estimated blood loss among women was 600 ml (iqr, 400-1000 ml) vs 500 ml (iqr, 200-600 ml) in men (p =.05).After multivariate analysis and adjustment of all independent predictors, female gender was associated with an eight-fold increased risk of renal function deterioration (odds ratio, 8.13; 95% confidence interval, 6.14-10.75).After logistic regression analysis, women were found to have an odds ratio of 7.36 (95% confidence interval, 6.68-8.11).In our study, access vessels were smaller in women and one-fifth of our female population required the use of endoconduits before fenestrated repair.This (b)(4).This pr covers 6 cases of major adverse events as defined in the article.- one male patient developed a non-st myocardial infarction treated with antiplatelet therapy and observation.- one female patient with an exacerbation of heart failure that resolved with medical therapy.- four patients (one woman and three men) diagnosed with pneumonia (one required tracheostomy).- one man diagnosed with small bowel obstruction that resolved with conservative medical therapy.
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Manufacturer Narrative
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This is a follow up report to advise that the description of event has been updated.The initial submission covered 7 cases of major adverse events.This has been updated as the investigation required some events to be investigated separately.The events that have been investigated separately are reported under the following prs: (b)(4): one man diagnosed with small bowel obstruction that resolved with conservative medical therapy.
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Event Description
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All patients that underwent fevar over a 2-year period, from 2013 to 2015, were includedwas performed.All patients in this series underwent fevar using the food and drug administration (fda) approved zenith fenestrated aaa endovascular graft (zfen), custom-made devices (cmds), or the investigational off-the-shelf p-branch fenestrated endograft.Indications included type iv thoracoabdominal, suprarenal, and juxtarenal aortic aneurysms, type ia endoleaks after previous evar, and penetrating atherosclerotic ulcerations.Demographics and comorbidities were evaluated for each gender group, including procedural data and imaging.Aneurysm classification was based on the recommended reporting standards for aneurysm repair of the society for vascular surgery.A juxtarenal aortic aneurysm is defined as an aneurysm with an infrarenal aortic neck of less than 10 mm with involvement of the aneurysmal dilatation up to the level of the renal arteries, which originate from normal aorta.Suprarenal aortic aneurysm involves the origin of at least one renal artery but do not extend into the celiac artery.Type iv thoracoabdominal aortic aneurysms involve the origin of all four visceral arteries, including the celiac axis, extending up to the diaphragmatic hiatus.Postprocedural events were defined as those within the first 30 days after the procedure.Outcomes were compared between males and females that underwent fevar.End points.The primary end point was the rate of major adverse events (maes) within 30 days after the target procedure.Maes were defined as the presence of one of the following: all-cause mortality, bowel ischemia (requiring intensification of medical therapy or surgical therapy), myocardial infarction (raised levels of cardiac biomarkers or electrocardiogram changes), paraplegia, respiratory failure (pneumonia or respiratory failure requiring ventilatory support for >24 hours), stroke, and renal failure requiring dialysis.Secondary end points included any perioperative complication, estimated blood loss, length of hospital stay, intensive care unit (icu) duration of stay, days to ambulate, days to start oral intake, rate of endoleak, procedure-related reinterventions, and renal adverse events defined as renal function deterioration with a 30% or greater increase of serum creatinine from baseline.Variations on the estimated glomerular filtration rate (egfr) from baseline according to gender were analyzed as well.A total of 79 patients underwent fevar, 63 men (80%) and 16 women (20%), with a median age of 73 years (interquartile range [iqr], 68-79 years).The zenith fenestrated aaa endograft was used in 60 patients (76%), zenith p-branch in 6 patients (8%), and investigational cmds in 13 patients (16%).Aneurysm anatomic location included 19 juxtarenal aneurysms (24%), 53 suprarenal aneurysms (67%), and 7 type iv thoracoabdominal aneurysms (9%).Median aneurysm size was 55 mm (iqr, 53-62 mm).Of the patients, 95% were asymptomatic at the time of repair.The median number of fenestrations was three.Men were more likely to have history of coronary artery disease (65% vs 19%; p =.01) and have higher values of preoperative creatinine (1.2 [iqr, 0.1-1.4] vs 0.9 [iqr, 0.7-1.3] among females; p <.02).Women were more likely to undergo endoconduits at the access site before the target procedure (19% vs 2% of men; p =.02).Anatomically, women had smaller diameters of the celiac artery (p =.003), superior mesenteric artery (p <.01), right renal (p <.01) and left renal arteries (p =.05), and common femoral arteries (right common femoral artery, p <.01; left common femoral artery, p =.05).No 30-day deaths occurred.The overall postoperative complication rate was similar among females and males (31% vs 33%; p >.5).However, women experienced longer times in the icu with a median of icu stay of 3 days (iqr, 2-5 days) vs 2 days (iqr 1-3 days; p =.05) in males.Similarly, the median duration of hospital stay was longer among women at 4.5 days (iqr, 3-6.5 days) vs 3 days (iqr, 2-4 days; p <.01).The median estimated blood loss among women was 600 ml (iqr, 400-1000 ml) vs 500 ml (iqr, 200-600 ml) in men (p =.05).After multivariate analysis and adjustment of all independent predictors, female gender was associated with an eight-fold increased risk of renal function deterioration (odds ratio, 8.13; 95% confidence interval, 6.14-10.75).After logistic regression analysis, women were found to have an odds ratio of 7.36 (95% confidence interval, 6.68-8.11).In our study, access vessels were smaller in women and one-fifth of our female population required the use of endoconduits before fenestrated repair.This (b)(4): this pr covers 6 cases of major adverse events as defined in the article.One male patient developed a non-st myocardial infarction treated with antiplatelet therapy and observation.One female patient with an exacerbation of heart failure that resolved with medical therapy.Four patients (one woman and three men) diagnosed with pneumonia (one required tracheostomy).One man diagnosed with small bowel obstruction that resolved with conservative medical therapy.
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