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COOK INC ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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| Model Number N/A |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Stroke/CVA (1770); Embolism/Embolus (4438); Renal Impairment (4499)
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Event Type
Injury
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Manufacturer Narrative
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B3 - date of event: occurred between (b)(6) 1999 and (b)(6) 2011.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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In the article "a decade of outcomes and predictors of sac enlargement after endovascular abdominal aortic aneurysm repair using zenith endografts in a japanese population" by iwakoshi et al (2014) published in the journal of vascular interventional radiology, it was reported that complications arose following placement of an unknown zenith flex aaa endovascular graft bifurcated main body (rpn: tffb)."materials and methods: patients: between july 1999 and august 2011, 127 patients underwent elective evar with zenith endografts.This was a retrospective review of prospectively collected clinical follow-up and imaging data and did not require institutional review board approval according to our institutional guidelines.All patients provided written informed consent to participate in all procedures associated with the study.The median age of patients was 78 years (range, 55¿91 y), and the median follow-up time was 43 months (range, 3¿143 mo).Table 1 summarizes patient demographics.The inclusion criteria for evar at our vascular center were (a) aneurysm sacs > 50 mm or sac > 40 mm with iliac artery aneurysms >35 mm on the minor axis of the maximal aneurysm plane, (b) an increase in sac diameter of 5 mm within 6 months, or (c) saccular aneurysms of any size.Exclusion criteria were (a) circular thrombus or extensive calcification in the proximal neck, (b) proximal neck diameter > 30 mm, and (c) proximal neck length < 10 mm.Patients with isolated iliac or ruptured aneurysms were not included in this study." "procedures and hospital stay: a team of interventional radiologists and vascular surgeons performed all evar procedures in an angiography suite using a fixed fluoroscopic unit.All patients received local anesthesia with conscious sedation.Access was achieved through cutdown of the bilateral femoral arteries." "image acquisition and follow-up: the follow-up protocol included a clinical examination, measurement of ankle-brachial index, biplanar plain abdominal radiography (anteroposterior and lateral projections), and nonenhanced arterial and delayed venous phase contrast-enhanced computed tomography (ct).Follow-up of patients using these modalities was usually performed at 1 week, 6 months, and 12 months after the procedures and annually thereafter.The origin of any type i or type iii endoleaks and sac enlargement > 5 mm determined by contrast-enhanced ct were confirmed by digital subtraction angiography.Type ii endoleaks were evaluated with digital subtraction angiography only when the aneurysmal sac enlarged >5 mm." "definition: aneurysm morphology, technical success, change in aneurysm size, and complications were defined according to the reporting standards suggested by the society for vascular surgery.In brief, we measured the minor axis of the maximal aneurysm plane on axial images of aneurysm sacs.A change in diameter of > or equal to 5 mm from the first set of postoperative values determined from imaging was considered significant.Neck length, neck diameter, and aortic angulation were assessed for planning evar using a three-dimensional workstation.A hostile neck was defined as having one or more of the following four features: short neck, length 10¿15 mm; infrarenal angulation, angle >60 degrees; wide neck, neck diameter >28 mm; and reverse taper.A reverse taper neck was defined as a proximal neck with gradual dilation of > or equal to 2 mm within the first 10 mm below the lowest renal artery.A friendly neck was defined as having no hostile neck features.Infrarenal angulation combined with a short or a reverse taper neck was defined as angulated and short (as) and angulated and reverse (ar), respectively (fig 1), and a short neck combined with a reverse taper neck was defined as short and reverse.Stent graft migration was defined as > 10 mm downward displacement of the device.Significant kinking was defined as graft kinking that caused > 50% stenosis or ischemic limb symptoms.The treating physicians obtained all ct measurements." "primary technical success was defined as successful access and deployment at the intended position without type i or iii endoleaks, significant kinking, obstruction of flow, or a need for open conversion.An unplanned additional endovascular procedure, such as placement of an extra-large bare metal stent or the need for unplanned main body extension to achieve aneurysm exclusion, was defined as an assisted primary technical success.Primary freedom from sac growth was defined as sac shrinkage or no change without additional intervention.Secondary freedom from sac growth was defined as sac shrinkage or no change achieved after a secondary procedure." "endpoints: endpoints of this investigation included initial technical success and complications, all-cause and aneurysm-related mortality, freedom from secondary intervention and risk factors for a secondary intervention, freedom from sac enlargement and risk factors for sac enlargement, and device migration and integrity." "statistical methods: data are shown as basic descriptive statistics, such as means and standard deviations for continuous variables and proportions and frequencies for categorical variables.Between-group comparisons were made using contingency table analysis with ¿2 test or fisher exact text (categorical variables), and statistically significant differences were determined using t tests (continuous variables).Overall survival rates, freedom from aneurysm-related mortality, reintervention, and sac enlargement (primary or secondary) were assessed using kaplan-meier curves.We also compared rates of freedom from primary sac enlargement between patients with a friendly neck and a hostile neck using the log-rank test.Risk factors for a secondary intervention and sac enlargement were identified by cox univariate analysis.Covariates entered into the model included age; gender; diabetes; hypertension; hyperlipidemia; coronary artery disease; chronic kidney disease; history of cigarette smoking; aneurysm sac diameter; short proximal neck (> 15 mm); suprarenal angulation (> 45 degrees); infrarenal angulation (>60 degrees); and reverse taper, as, and angulated and reverse necks.Factors with p<.10 in the univariate cox analysis were entered into multivariate regression models.P <.05 was considered statistically significant in all models.All data were statistically analyzed using software." "results: friendly necks were present in 83 (65%) patients, and hostile necks were present in 44 (35%) patients.Among patients with hostile necks, 31 (25%) had one hostile feature, and 13 (10%) had two hostile features.Table 2 in the article summarizes the demographics and anatomic characteristics of the patients.There were 5 patients lost to follow-up, and 23 patients did not undergo ct imaging at the final visit." "initial technical success and complication: a bifurcated device was deployed in 125 patients, and 2 patients received an aorto-uni-iliac device.Iliac limb extensions to the external iliac artery (eia) were performed with embolization of unilateral internal iliac artery in 41 (32%) patients, whereas bilateral eia extensions with iia embolization were performed in 1 patient." "the primary technical success rate of evar was 92.1% (117 of 127 patients).Type ia endoleaks developed in 10 patients.Subsequent unplanned adjunctive procedures were required to achieve a proximal seal, which consisted of the deployment of an extra-large stent in seven patients and the placement of a main body extension in three patients.Proximal adjunctive procedures were required in three (4%) patients with friendly necks and seven (16%) patients with hostile necks (p =-.020).Among the seven patients with hostile necks, four patients had as necks.These adjunctive procedures resolved eight type ia endoleaks, resulting in a primary assisted success rate of 98.4% (125 of 127 patients).The remaining two patients had minor residual type ia endoleaks that spontaneously resolved by the first postoperative ct scan performed 1 week after the procedure.No type ib or iii endoleaks were detected at the end of the procedures.A renal artery stent was deployed in one patient because of thrombus formation in the proximal renal artery." "according to the reporting standard for evar, five moderate and two mild complications developed in seven (5.5%) patients.Cerebellar infarction (cerebrovascular grade 2) occurred in one patient, and renal insufficiency (grade 2), cholesterol emboli (grade 1), and acute limb occlusion developed in two patients.Thrombectomy and intraarterial urokinase infusions restored blood flow to the iliac limbs of the two patients with acute limb occlusion.The in-hospital and early postoperative (30-day) mortality rate was 0%." "long-term outcomes all-cause and aneurysm-related mortality rates: during the follow-up period, 49 patients died of malignant tumors (n = 11), pneumonia (n = 9), stroke (n = 5), acute myocardial infarction (n=5), and aneurysm-related cause (n = 3).All three aneurysms enlarged after evar in the three patients whose deaths were aneurysm related.A type ii endoleak was treated by embolization in the first patient, but the aneurysm sac continued to enlarge, and the patient died of aneurysm rupture at 28 months.The second patient in whom no endoleaks were detected refused further treatment and died of rupture 76 months after evar.The last patient was converted to surgical repair and died of graft infection at 77 months.Overall survival at 1, 3, 5, and 10 years was 95%, 87%, 77%, and 39%, and freedom from aneurysm-related mortality was 100%, 100%, 99%, and 93%." "endoleak and secondary interventions: at some point during the follow-up period, 25 endoleaks became evident in 21 (17%) patients (article table 3).Two types of endoleaks were detected in 4 of 21 patients in different periods.Type ia, ib, ii, and iii endoleaks were detected in 4, 2, 16, and 3 patients.Embolization of the type ii endoleaks was the most common intervention (n = 9), followed by adding a bridging stent graft at the junction (n = 8), stent placement for iliac artery stenosis (n = 6), adding a main body extension for type ia endoleak correction (n = 4; combined with chimney technique, n = 2), thrombectomy for iliac limb occlusion (n = 2), and limb extension to resolve type 1b endoleaks (n = 2).One intervention was performed in 16 patients, two interventions were performed in 4 patients, three interventions were performed in 1 patient, and four interventions were performed in 1 patient.Most (82%) second interventions were performed within 4 years after evar; in two cases, second interventions were required after 5 years.Rates of freedom from a secondary intervention at 1, 3, 5, and 10 years were 97%, 91%, 88%, and 70%.Multivariate analysis revealed aneurysm sac diameter as the only predictor of a secondary intervention (hazard ratio, 1.08; 95% confidence interval, 1.01¿1.15; p=.020)." "freedom from sac enlargement and risk factors for sac enlargement: sac enlargement occurred in 19 patients.Three patients refused a secondary intervention, and the intervention was converted to open repair in another patient.The remaining 15 patients underwent a second intervention, which prevented growth of the aneurysm in 9 patients.Rates of primary freedom from sac enlargement at 1, 3, 5, and 10 years were 99%, 87%, 75%, and 67%, and rates of secondary freedom from sac enlargement were 100%, 93%, 87%, and 78% (journal article fig 2a).The rates of primary freedom from sac enlargement at 1, 3, 5, and 10 years were 99%, 92%, 76%, and 72% for patients with friendly necks and 94%, 72%, 72%, and 36% for patients with hostile necks; this did not reach statistical significance (p=.132).However, 3-year rates of freedom from sac enlargement were significantly lower in patients with two features of hostile necks (24%) compared with patients with friendly necks (91%) or patients with necks with one hostile feature (95%) (p o.001) (journal article fig 2b).Univariate analysis showed preoperative sac diameter, suprarenal angulation (4 45 degrees), and as neck as risk factors associated with sac enlargement.Multivariate analysis including these three factors revealed preoperative sac diameter and as neck as independent risk factors for sac enlargement (journal article table 4)." "migration and device integrity: stents migrated >10mm in two patients resulting in aneurysm enlargement; both patients refused secondary intervention, one owing to malignant tumor and the other owing to advanced age.Physical changes in alignment such as stent grafts straightened by extra-large metal stents returning to an angulated configuration occurred in two patients with as necks (journal article fig 3a¿e), and aneurysms became enlarged in both patients.One patient underwent proximal stent graft extension with chimney technique; the second patient refused secondary intervention because of advanced age." this report captures five patients who experienced initial complications following the placement of a zenith device.The complications included the following: cerebellar infarction (cerebrovascular grade 2) occurred in one patient, renal insufficiency (grade 2) in 2 patients and cholesterol emboli (grade 1) in 2 patients.Additional events mentioned in the article are referenced in reports with patient identifiers: (b)(6).Literature citation: iwakoshi, s., ichihashi, s., higashiura, w., itoh, h., sakaguchi, s., tabayashi, n., uchida, h., & kichikawa, k.(2014).A decade of outcomes and predictors of sac enlargement after endovascular abdominal aortic aneurysm repair using zenith endografts in a japanese population.Journal of vascular and interventional radiology, 25(5), 694¿701.Https://doi.Org/10.1016/j.Jvir.2014.01.017.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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Cook inc.Has been unable to submit reports due to issues with receiving new ssl certificates for esg as2 trading partners from the esg help desk.This issue was discovered over the weekend on (b)(6) 2023.Cook has been in communication with the fda regarding this issue and was provided the needed security certificate on (b)(6) 2023.Per (b)(4), questions and answers about emdr - electronic medical device reporting - guidance for industry, user facilities and fda staff, section d: "if a manufacturer or importer is unable to submit a report on time due to an outage affecting the esg or the cdrh emdr processing system, it may document its attempts at timely filing in block h10 for the affected reports and submit reports electronically as soon as the esg or cdrh emdr processing system is operational." an email has been sent to fda as the guidance instructs informing fda of the information set forth in the guidance regarding these delayed submissions.Investigation / evaluation: in the article "a decade of outcomes and predictors of sac enlargement after endovascular abdominal aortic aneurysm repair using zenith endografts in a japanese population" by iwakoshi et al (2014) published in the journal of vascular interventional radiology, it was reported that five patients experienced initial complications following the placement of an unknown zenith flex aaa endovascular graft bifurcated main body (rpn: tffb).The complications included the following: cerebellar infarction (cerebrovascular grade 2) occurred in one patient; renal insufficiency (grade 2) in 2 patients; cholesterol emboli (grade 1) in 2 patients.Reviews of documentation including the complaint history, drawing, quality control procedures, specifications, manufacturing instructions (mi), and instructions for use (ifu) of the complaint device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, five still images were provided within the literature, but the images were de-identified and it could not be determined what patient the images belong to.The images showed failed clinical result in aaa with as (angulated and short) neck.The first still image (a) is a aortogram and shows the aaa with as proximal neck.The second still image (b) shows the deployment of a zenith endograft, a palmaz stent was deployed inside the endograft.The third still image (c) shows the addition of the palmaz stent forced the stent graft to be straightened.The fourth still image (d) is an abdominal radiograph obtained 1 day after the procedure and shows a straightened endograft with palmaz stent.The fifth still image (e) is an abdominal radiograph obtained 1 year after the procedure and shows a deformed palmaz stent; the straightened stent graft returned to an angulated configuration.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded sufficient inspection activities are in place to identify this failure mode prior to distribution.The customer did not provide the lot number for the complaint device.Cook reviewed the sales history for this customer and was unable to identify the complaint lot.The device history record could not be reviewed.Based on this information, the device was manufactured to specification.There is no evidence of nonconforming material in house or in the field.Cook also reviewed product labeling.The product ifu, t_zaaaf36_rev 6 ¿zenith flex aaa graft with the h&l one-shot introduction system,¿ provides the following information to the user related to the reported failure mode: "4 warnings and precautions: 4.1 general.Patients experiencing reduced blood flow through the graft limb and/or leaks may be required to undergo secondary interventions or surgical procedures.4.2 patient selection, treatment and follow-up: the zenith flex aaa endovascular graft is designed to treat aortic neck diameters no smaller than 18 mm and no larger than 32 mm.The zenith flex aaa endovascular graft is designed to treat proximal aortic necks (distal to the lowest renal artery) of at least 15 mm in length.Iliac artery distal fixation site greater than 10 mm in length and 7.5 - 20 mm in diameter (measured outer wall to outer wall) is required.These sizing measurements are critical to the performance of the endovascular repair.Key anatomical elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation (>60 degrees for infrarenal neck to axis of aaa or >45 degrees for suprarenal neck relative to the immediate infrarenal neck); short proximal aortic neck (<15 mm); an inverted funnel shape (greater than 10% increase in diameter over 15 mm of proximal aortic neck length); and circumferential thrombus and/or calcification at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.In the presence of anatomical limitations, a longer neck may be required to obtain adequate sealing and fixation.Irregular calcification and/or plaque may compromise the attachment and sealing at the fixation sites.Necks exhibiting these key anatomical elements may be more conducive to graft migration or endoleak.Adequate iliac or femoral access is required to introduce the device into the vasculature.Access vessel diameter (measured inner wall to inner wall) and morphology (minimal tortuosity, occlusive disease and/or calcification) should be compatible with vascular access techniques and delivery systems of a 16 french to 22 french vascular introducer sheath.Vessels that are significantly calcified, occlusive, tortuous, or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization.A vascular conduit technique may be necessary to achieve success in some patients.The zenith flex aaa endovascular graft with the h&l one-shot introduction system is not recommended in patients who cannot tolerate contrast agents necessary for intraoperative and postoperative follow-up imaging.All patients should be monitored closely and checked periodically for a change in the condition of their disease and the integrity of the endoprosthesis.Diameters: utilizing ct, diameter measurements should be determined from the outer wall to outer wall vessel diameter (not lumen measurement) to help with proper device sizing and device selection.The contrast-enhanced spiral ct scan must start 1 cm superior to the celiac axis and continue through the femoral heads at an axial thickness slice of 3 mm or less.Lengths: 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 the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysm or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.Specific follow-up guidelines are described in section 12, imaging guidelines and postoperative follow-up.After endovascular graft placement, patients should be regularly monitored for perigraft flow, aneurysm growth or changes in the structure or position of the endovascular graft.At a minimum, annual imaging is required, including: 1) abdominal radiographs to examine device integrity (separation between components, stent fracture or barb separation) and 2) contrast and non-contrast ct to examine aneurysm changes, perigraft flow, patency, tortuosity and progressive disease.If renal complications or other factors preclude the use of image contrast media, abdominal radiographs and duplex ultrasound may provide similar information.4.4 device selection: strict adherence to the zenith flex aaa endovascular graft ifu sizing guide is strongly recommended when selecting the appropriate device size (tables 10.5.1 through 10.5.2).Appropriate device oversizing has been incorporated into the ifu sizing guide.Sizing outside of this range can result in endoleak, fracture, migration, device infolding or compression 4.5 implant procedure: appropriate procedural imaging is required to successfully position the zenith flex aaa endovascular graft and assure accurate apposition to the aortic wall.Inaccurate placement and/or incomplete sealing of the zenith flex aaa endovascular graft within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries.Renal artery patency must be maintained to prevent/reduce the risk of renal failure and subsequent complications.5.2 potential adverse events: adverse events that may occur and/or require intervention include, but are not limited to: arterial or venous thrombosis and/ or pseudoaneurysm bowel complications (e.G., ileus, transient ischemia, infarction, necrosis) cardiac complications and subsequent attendant problems (e.G., arrhythmia, myocardial infarction, congestive heart failure, hypotension, hypertension).Embolization (micro and marco) with transient or permanent ischemia infarction neurologic local or systemic complications and subsequent attendant problems (e.G., stroke, transient ischemic attack, paraplegia, paraparesis, paralysis renal complications and subsequent attendant problems (e g , artery stenosis or occlusion, contrast toxicity, infarct, insufficiency, failure) 8 patient counseling information.Physicians should refer patients to the patient guide regarding risks occurring during or after implantation of the device.Procedure-related risks include cardiac, pulmonary, neurologic, bowel and bleeding complications.Device related risks include occlusion, endoleak, aneurysm enlargement, fracture, potential for reintervention and open surgical conversion, rupture, and death.10.5 device sizing guidelines: the choice of diameter should be determined from the outer wall to outer wall vessel diameter and not the lumen diameter.Undersizing or oversizing may result in incomplete sealing or compromised flow.11 directions for use: anatomical requirements.Proximal aortic neck lengths should be a minimum of 15 mm with a diameter measured outer wall to outer wall of 18 ¿ 32 mm.12 imaging guidelines and postoperative follow-up: 12.1 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 the performance of their endovascular graft.Patients with specific clinical (e.G., endoleaks, enlarging aneurysm or changes in the structure or position of the endovascular graft) should receive additional follow-up.Patients should be counseled on the importance of adhering to the follow-up schedule.Both during the first year and at early intervals thereafter.Patients should be told that regular and consistent follow-up is a critical part of ensuring the ongoing safety and effectiveness of endovascular treatment of aaas." based on the information provided, review of medical imaging provided by the literature, and the results of our investigation, cook could not establish a definitive cause for the event.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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