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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 Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
High Blood Pressure/ Hypertension (1908)
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Event Type
Injury
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Event Description
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Burke et al 2017: incidence and clinical significance of renal infarct after fenestrated endovascular aortic aneurysm repair: burke et al 2017.A retrospective review of all patients who underwent fevar with unenhanced and contrast-enhanced ct angiography during a 4-year period.Fevar was accomplished with either a u.S.Food and drug administration¿approved device (zenith fenestrated aaa endovascular graft, cook medical) or enrollment into an investigation device exemption protocol (zfen g040063, investigation device exemption g110101) a total of 123 patients were evaluated from a prospectively maintained database of all patients undergoing fevar at our institution.Thirty-three patients were excluded for review secondary to lack of an accessible contrast-enhanced pre- or postoperative ct examination within our pacs or serum creatinine value.The remaining 90 patients were included for review.Fifteen patients were classified as having a pararenal abdominal aortic aneurysm, and the remaining 75 met criteria for thoracoabdominal aneurysm.Ninety patients were included for analysis.All patients had a mild progressive increase in serum creatinine level after fevar.Twenty-three patients (26%) had a renal infarct identified on post-fevar ct, nine (39%) of which were secondary to intentional exclusion of an accessory renal artery and 14 (61%) of which were presumed to be embolic.Two patients with presumed embolic infarcts and three with exclusion of an accessory renal artery had an increase in serum creatinine level of greater than 0.3 mg/dl at 1 month after fevar.Statistical analysis showed a significant difference between pre- and postoperative serum creatinine levels and estimated gfrs, regardless of whether the patient had a renal infarct (p = 0.05).None of the patients in the cohort required permanent dialysis; one patient required temporary hemodialysis for rhabdomyolysis.Twenty-three patients (26%) had at least one renal infarct identified on post-fevar ct (mean, 1.3 infarcts; range, 1¿4 infarcts).All patients were classified as having a thoracoabdominal aneurysm.Serum creatinine levels and estimated gfrs before and after fevar for patients with renal infarcts there was a statistically significant increase in serum creatinine level after fevar at the 1-month (p = 0.005) and 1-year (p = 0.02) time points.However, there was no statistically significant difference in estimated gfr at the 1-month (p = 0.15) and 1-year (p = 0.37) time points.Of the 23 patients, nine (39%) underwent intentional exclusion of an accessory renal artery, and only three of those nine patients (33%) had an increase in serum creatinine level of 0.3 mg/dl.The remaining 14 (61%) patients were assumed to have renal infarcts secondary to plaque embolization, because the main renal arteries appeared patent on the post-fevar images.Only two of these 14 patients (14%) had an increase in serum creatinine level of greater than 0.3 mg/dl during the post-fevar period.No patient in either group required temporary or permanent hemodialysis during the study period.This pr403566: adverse physiological response: twenty-three of 90 patients (26%) had documented new or worsening hypertension after fevar that required a change in the patient¿s antihypertensive drug regimen.There is no statistical relationship between renal volume loss and new or worsening hypertension.Also: pr403560: twenty-three patients (26%) had at least one renal infarct identified on post-fevar ct (mean, 1.3 infarcts; range, 1¿4 infarcts).All patients were classified as having a thoracoabdominal aneurysm.Serum creatinine levels and estimated gfrs before and after fevar for patients with renal infarcts there was a statistically significant increase in serum creatinine level after fevar at the 1-month (p = 0.005) and 1-year (p = 0.02) time points.However, there was no statistically significant difference in estimated gfr at the 1-month (p = 0.15) and 1-year (p = 0.37) time points.Of the 23 patients, nine (39%) underwent intentional exclusion of an accessory renal artery, and only three of those nine patients (33%) had an increase in serum creatinine level of 0.3 mg/dl.The remaining 14 (61%) patients were assumed to have renal infarcts secondary to plaque embolization, because the main renal arteries appeared patent on the post-fevar images.Only two of these 14 patients (14%) had an increase in serum creatinine level of greater than 0.3 mg/dl during the post-fevar period.No patient in either group required temporary or permanent hemodialysis during the study period.
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Manufacturer Narrative
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Event information was taken from review of a journal article: incidence and clinical significance of renal infarct after fenestrated endovascular aortic aneurysm repair: l.M.B.Burke et al 2017.Doi: (b)(6).
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Event Description
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Burke et al 2017: incidence and clinical significance of renal infarct after fenestrated endovascular aortic aneurysm repair: burke et al 2017.A retrospective review of all patients who underwent fevar with unenhanced and contrast-enhanced ct angiography during a 4-year period.Fevar was accomplished with either a u.S.Food and drug administration¿approved device (zenith fenestrated aaa endovascular graft, cook medical) or enrollment into an investigation device exemption protocol (zfen g040063, investigation device exemption g110101) a total of 123 patients were evaluated from a prospectively maintained database of all patients undergoing fevar at our institution.Thirty-three patients were excluded for review secondary to lack of an accessible contrast-enhanced pre- or postoperative ct examination within our pacs or serum creatinine value.The remaining 90 patients were included for review.Fifteen patients were classified as having a pararenal abdominal aortic aneurysm, and the remaining 75 met criteria for thoracoabdominal aneurysm.Ninety patients were included for analysis.All patients had a mild progressive increase in serum creatinine level after fevar.Twenty-three patients (26%) had a renal infarct identified on post-fevar ct, nine (39%) of which were secondary to intentional exclusion of an accessory renal artery and 14 (61%) of which were presumed to be embolic.Two patients with presumed embolic infarcts and three with exclusion of an accessory renal artery had an increase in serum creatinine level of greater than 0.3 mg/dl at 1 month after fevar.Statistical analysis showed a significant difference between pre- and postoperative serum creatinine levels and estimated gfrs, regardless of whether the patient had a renal infarct (p = 0.05).None of the patients in the cohort required permanent dialysis; one patient required temporary hemodialysis for rhabdomyolysis.Twenty-three patients (26%) had at least one renal infarct identified on post-fevar ct (mean, 1.3 infarcts; range, 1¿4 infarcts).All patients were classified as having a thoracoabdominal aneurysm.Serum creatinine levels and estimated gfrs before and after fevar for patients with renal infarcts there was a statistically significant increase in serum creatinine level after fevar at the 1-month (p = 0.005) and 1-year (p = 0.02) time points.However, there was no statistically significant difference in estimated gfr at the 1-month (p = 0.15) and 1-year (p = 0.37) time points.Of the 23 patients, nine (39%) underwent intentional exclusion of an accessory renal artery, and only three of those nine patients (33%) had an increase in serum creatinine level of 0.3 mg/dl.The remaining 14 (61%) patients were assumed to have renal infarcts secondary to plaque embolization, because the main renal arteries appeared patent on the post-fevar images.Only two of these 14 patients (14%) had an increase in serum creatinine level of greater than 0.3 mg/dl during the post-fevar period.No patient in either group required temporary or permanent hemodialysis during the study period.This pr403566: adverse physiological response: twenty-three of 90 patients (26%) had documented new or worsening hypertension after fevar that required a change in the patient¿s antihypertensive drug regimen.There is no statistical relationship between renal volume loss and new or worsening hypertension.Also: pr403560: twenty-three patients (26%) had at least one renal infarct identified on post-fevar ct (mean, 1.3 infarcts; range, 1¿4 infarcts).All patients were classified as having a thoracoabdominal aneurysm.Serum creatinine levels and estimated gfrs before and after fevar for patients with renal infarcts there was a statistically significant increase in serum creatinine level after fevar at the 1-month (p = 0.005) and 1-year (p = 0.02) time points.However, there was no statistically significant difference in estimated gfr at the 1-month (p = 0.15) and 1-year (p = 0.37) time points.Of the 23 patients, nine (39%) underwent intentional exclusion of an accessory renal artery, and only three of those nine patients (33%) had an increase in serum creatinine level of 0.3 mg/dl.The remaining 14 (61%) patients were assumed to have renal infarcts secondary to plaque embolization, because the main renal arteries appeared patent on the post-fevar images.Only two of these 14 patients (14%) had an increase in serum creatinine level of greater than 0.3 mg/dl during the post-fevar period.No patient in either group required temporary or permanent hemodialysis during the study period.
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Manufacturer Narrative
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No part of any device 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 numbers are 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) found to contain appropriate warnings, precautions, and instructions to the user, including: 4.Warnings and precautions: 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.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) 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 could not be determined.These are known effects of failure and are 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.Event information was taken from review of a journal article: incidence and clinical significance of renal infarct after fenestrated endovascular aortic aneurysm repair: l.M.B.Burke et al 2017.Doi: doi:10.2214/ajr.16.16562.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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