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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
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Sepsis (2067)
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Event Type
Death
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Event Description
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Association of baseline chronic kidney disease stage with short- and long-term outcomes after fenestrated endovascular aneurysm repair.Shernaz s.Dossabhoy et al 2023.Of 244 consecutive fevar performed from september 2012 to january 2022, 184 were treated with fda-approved cook zfen or clinical-trial cook zenith p-branch fenestrated devices.Total of 184 patients - 96.2% (177/184) treated with zfen and 3.8% (7/184) cook zenith p-branch; average age 73.9±7.6.A single institution, retrospective review of a prospectively maintained database of all consecutive fevar performed from september 2012 to january 2022.Patients treated with an fda-approved cook zfen or clinical-trial cook zenith p-branch device, which is a fenestrated endograft configured with 3 fenestrations and onescallop (cook medical, inc) were included.Those with any adjunctive modifications (e.G., chimney, snorkel, periscope, or laser fenestration) were excluded from the analysis.This study was approved by the stanford university institutional review board for retrospective review of deidentified patient data.The cohort was stratified by severity of ckd stage as none-to-mild ckd (defined as no ckd or stage 1e2) and moderate-to-severe ckd (defined as stage 3e5).Ckd stage was determined using preoperative serum creatinine (scr) and estimated glomerular filtration rate (egfr) calculated using the 2021 ckd-epi creatinine equation recommended by the national kidney foundation.Baseline demographics, anatomic and device features, operative characteristics, 30-day postoperative events, and 1-year technical outcomes and survival, and long-term outcomes, including rates of dialysis, endoleak, sac regression, reintervention, and overall survival at latest follow-up, were obtained from the database.Comorbidities were assessed using the previously validated svs comorbidity severity score.Operative technical success was defined as all target vessels patent without proximal endoleak on completion angiogram.The primary outcome was the rate of postoperative acute kidney injury (aki), defined by risk, injury, failure, loss, end stage criteria as 1.5x increase in scr from baseline to hospital discharge.Secondary outcomes included 30-day perioperative complications (myocardial infarction [mi], stroke, bleeding, access complications, bowel ischemia, limb ischemia, new-onset dialysis, reintervention, and mortality) and 1- and 5-year overall survival and rates of dialysis, renal target artery patency, type i or iii endoleak, and reintervention.These 5-year outcomes were considered ¿¿longterm¿¿ outcomes in this cohort and consistent with the existing literature on fevar.16 additional secondary end points assessed at latest follow-up included aneurysm sac regression, total number of surveillance computed tomography (ct) scans, and ckd stage progression.Progression of ckd stage was defined as worsening in ckd stage from baseline to latest follow-up by 1 stage (i.E., ckd stage 2 at baseline to stage 3 at latest followup).Ckd stage at latest follow-up was determined using last available scr, from which egfr was then calculated using age at latest follow-up, as described above.Additional 30-day perioperative events were similar between groups (table iii).No significant differences were observed in rates of new-onset dialysis, any major adverse event, reintervention, or mortality at 30 days.The overall 30-day mortality rate was 2.2% with 4 deaths occurring in 1 patient with baseline ckd stage 2, 2 patients with ckd stage 3, and 1 patient with ckd stage 4.On kaplan-meier analysis, overall survival at 1 and 5 years was significantly lower for the ckd 3e5 group compared to ckd 1e2 (82.3% vs.95.1%, p < 0.01; and 55.4% vs.70.8%, p ¼ 0.02;).Freedom from new-onset chronic dialysis was also significantly lower for ckd 3e5 at 1 year (94.4% vs.100%, p ¼ 0.02;) and 5 years (84.7% vs.100%, p < 0.01; ).There were no significant differences in long-term technical outcomes, including renal artery patency, reinterventions, or type i or iii endoleak at 1 and 5 years.For patients with available postoperative surveillance imaging (n ¼ 167), mean aneurysm sac regression at latest follow-up was 10.8 ± 10.3 mm for the overall cohort and did not significantly differ between groups (ckd 1e2 10.5 ± 10.9 mm vs.Ckd 3e5 11.3 ± 9.2 mm, p ¼ 0.58).The mean number of ct scans during follow-up was not significantly different between ckd 1e2 vs.Ckd 3e5 groups (4 ± 2 scans vs.3 ± 2 scans, p ¼ 0.11).For patients with at least one scr value available at 30 days (n ¼ 153), ckd stage progression occurred in 47 patients (30.7%) at latest follow-up but did not differ between stratified groups (ckd 1e2 36.0% vs.Ckd 3e 5 23.4%; p ¼ 0.17;.Of note, 24 patients (15.7%) were observed to have improved their ckd stage by 1 stage at latest follow-up.The mean follow-up time for the overall cohort was 34.3 ± 24.5 months (range, 0 to 101 months or 8.4 years) there were 49 deaths during the follow-up period (26.6% of the total cohort) with 4 of these deaths occurring within 30 days of the index fevar procedure (2.2% of total cohort).Of the 49 total deaths, 6 were aortic aneurysm related.These included aortic graft infection (n ¼ 1), bowel ischemia (n ¼ 2), hemorrhagic shock (n ¼ 1), cardiogenic shock after reintervention for endoleak (n ¼ 1), and renal stent occlusion with attempted embolectomy at outside hospital complicated by perforation leading to hemorrhagic shock and multisystem organ failure (n ¼ 1).The other 43 causes of death included unknown (n ¼ 23), cancer (n ¼ 4), mi or heart failure (n ¼ 8), proximal acute aortic dissection (n ¼ 1), endocarditis with embolic stroke (n ¼ 1), stroke (n ¼ 1), pulmonary embolism (n ¼ 1), pneumonia (n ¼ 1), sepsis (n ¼ 1), acute on chronic mesenteric ischemia (n ¼ 1), and motor vehicle accident (n ¼ 1).While there were no deaths specifically attributed to ckd or dialysis needs in this cohort, we can only postulate that chronic renal dysfunction may have contributed to some of the disease states and causes of mortality as listed above.Major adverse events - death of the patients: request from investigator to split the complaint: (b)(4) will cover: adverse physiological events.(all patients died): total 9 patients myocardium infarction or heart failure 4 patients (see related (b)(4) for myocardial infarction <30 days resulting in death in 4 further patients) proximal acute aortic dissection 1 patient endocarditis with embolic stroke 1 patient stroke 1 patient pulmonary embolism 1 patient pneumonia 1 patient this (b)(4) will cover: adverse physiological event - sepsis.(patients died): total 1 patient.
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Manufacturer Narrative
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Event information was taken from literature article: 'association of baseline chronic kidney disease stage with short- and long-term outcomes after fenestrated endovascular aneurysm repair.' authors: shernaz s.Dossabhoy, sabina m.Sorondo, andrea t.Fisher, vy t.Ho, jordan r.Stern, and jason t.Lee, doi: https://doi.Org/10.1016/j.Avsg.2023.07.102.The complaint device is an unknown z-fen graft manufactured by william a cook australia.
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Manufacturer Narrative
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No part of any 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, and the following response was received "hi we are not able to provide such information.Complications not associated with the devices".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 (us) devices for general information was reviewed, and found to contain appropriate warnings, precautions, and instructions to the user, including: 5 potential adverse events aneurysm rupture and death death 8 patient counseling information long-term performance of fenestrated endovascular grafts and stents in the 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.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.Event information was taken from literature article: 'association of baseline chronic kidney disease stage with short- and long-term outcomes after fenestrated endovascular aneurysm repair.' authors: shernaz s.Dossabhoy, sabina m.Sorondo, andrea t.Fisher, vy t.Ho, jordan r.Stern, and jason t.Lee.Doi: https://doi.Org/10.1016/j.Avsg.2023.07.102.The complaint devices are unknown z-fen grafts manufactured by william a cook australia.It is not known if any or all of the events reported were caused or contributed to by any cook device, the events are being reported out of an abundance of caution.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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Association of baseline chronic kidney disease stage with short- and long-term outcomes after fenestrated endovascular aneurysm repair.Shernaz s.Dossabhoy et al 2023.Of 244 consecutive fevar performed from september 2012 to january 2022, 184 were treated with fda-approved cook zfen or clinical-trial cook zenith p-branch fenestrated devices.Total of 184 patients - 96.2% (177/184) treated with zfen and 3.8% (7/184) cook zenith p-branch; average age 73.9±7.6.A single institution, retrospective review of a prospectively maintained database of all consecutive fevar performed from september 2012 to january 2022.Patients treated with an fda-approved cook zfen or clinical-trial cook zenith p-branch device, which is a fenestrated endograft configured with 3 fenestrations and onescallop (cook medical, inc) were included.Those with any adjunctive modifications (e.G., chimney, snorkel, periscope, or laser fenestration) were excluded from the analysis.This study was approved by the stanford university institutional review board for retrospective review of deidentified patient data.The cohort was stratified by severity of ckd stage as none-to-mild ckd (defined as no ckd or stage 1e2) and moderate-to-severe ckd (defined as stage 3e5).Ckd stage was determined using preoperative serum creatinine (scr) and estimated glomerular filtration rate (egfr) calculated using the 2021 ckd-epi creatinine equation recommended by the national kidney foundation.Baseline demographics, anatomic and device features, operative characteristics, 30-day postoperative events, and 1-year technical outcomes and survival, and long-term outcomes, including rates of dialysis, endoleak, sac regression, reintervention, and overall survival at latest follow-up, were obtained from the database.Comorbidities were assessed using the previously validated svs comorbidity severity score.Operative technical success was defined as all target vessels patent without proximal endoleak on completion angiogram.The primary outcome was the rate of postoperative acute kidney injury (aki), defined by risk, injury, failure, loss, end stage criteria as 1.5x increase in scr from baseline to hospital discharge.Secondary outcomes included 30-day perioperative complications (myocardial infarction [mi], stroke, bleeding, access complications, bowel ischemia, limb ischemia, new-onset dialysis, reintervention, and mortality) and 1- and 5-year overall survival and rates of dialysis, renal target artery patency, type i or iii endoleak, and reintervention.These 5-year outcomes were considered ¿¿longterm¿¿ outcomes in this cohort and consistent with the existing literature on fevar.16 additional secondary end points assessed at latest follow-up included aneurysm sac regression, total number of surveillance computed tomography (ct) scans, and ckd stage progression.Progression of ckd stage was defined as worsening in ckd stage from baseline to latest follow-up by 1 stage (i.E., ckd stage 2 at baseline to stage 3 at latest followup).Ckd stage at latest follow-up was determined using last available scr, from which egfr was then calculated using age at latest follow-up, as described above.Additional 30-day perioperative events were similar between groups (table iii).No significant differences were observed in rates of new-onset dialysis, any major adverse event, reintervention, or mortality at 30 days.The overall 30-day mortality rate was 2.2% with 4 deaths occurring in 1 patient with baseline ckd stage 2, 2 patients with ckd stage 3, and 1 patient with ckd stage 4.On kaplan-meier analysis, overall survival at 1 and 5 years was significantly lower for the ckd 3e5 group compared to ckd 1e2 (82.3% vs.95.1%, p < 0.01; and 55.4% vs.70.8%, p ¼ 0.02;).Freedom from new-onset chronic dialysis was also significantly lower for ckd 3e5 at 1 year (94.4% vs.100%, p ¼ 0.02;) and 5 years (84.7% vs.100%, p < 0.01; ).There were no significant differences in long-term technical outcomes, including renal artery patency, reinterventions, or type i or iii endoleak at 1 and 5 years.For patients with available postoperative surveillance imaging (n ¼ 167), mean aneurysm sac regression at latest follow-up was 10.8 ± 10.3 mm for the overall cohort and did not significantly differ between groups (ckd 1e2 10.5 ± 10.9 mm vs.Ckd 3e5 11.3 ± 9.2 mm, p ¼ 0.58).The mean number of ct scans during follow-up was not significantly different between ckd 1e2 vs.Ckd 3e5 groups (4 ± 2 scans vs.3 ± 2 scans, p ¼ 0.11).For patients with at least one scr value available at 30 days (n ¼ 153), ckd stage progression occurred in 47 patients (30.7%) at latest follow-up but did not differ between stratified groups (ckd 1e2 36.0% vs.Ckd 3e 5 23.4%; p ¼ 0.17;.Of note, 24 patients (15.7%) were observed to have improved their ckd stage by 1 stage at latest follow-up.The mean follow-up time for the overall cohort was 34.3 ± 24.5 months (range, 0 to 101 months or 8.4 years).There were 49 deaths during the follow-up period (26.6% of the total cohort) with 4 of these deaths occurring within 30 days of the index fevar procedure (2.2% of total cohort).Of the 49 total deaths, 6 were aortic aneurysm related.These included aortic graft infection (n ¼ 1), bowel ischemia (n ¼ 2), hemorrhagic shock (n ¼ 1), cardiogenic shock after reintervention for endoleak (n ¼ 1), and renal stent occlusion with attempted embolectomy at outside hospital complicated by perforation leading to hemorrhagic shock and multisystem organ failure (n ¼ 1).The other 43 causes of death included unknown (n ¼ 23), cancer (n ¼ 4), mi or heart failure (n ¼ 8), proximal acute aortic dissection (n ¼ 1), endocarditis with embolic stroke (n ¼ 1), stroke (n ¼ 1), pulmonary embolism (n ¼ 1), pneumonia (n ¼ 1), sepsis (n ¼ 1), acute on chronic mesenteric ischemia (n ¼ 1), and motor vehicle accident (n ¼ 1).While there were no deaths specifically attributed to ckd or dialysis needs in this cohort, we can only postulate that chronic renal dysfunction may have contributed to some of the disease states and causes of mortality as listed above.Major adverse events - death of the patients: request from investigator to split the complaint: (b)(4) will cover: adverse physiological events.(all patients died): total 9 patients.Myocardium infarction or heart failure 4 patients (see related (b)(4) for myocardial infarction <30 days resulting in death in 4 further patients).Proximal acute aortic dissection 1 patient.Endocarditis with embolic stroke 1 patient.Stroke 1 patient.Pulmonary embolism 1 patient.Pneumonia 1 patient.This (b)(4) will cover: adverse physiological event - sepsis.(patients died): total 1 patient.
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