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| Model Number N/A |
| Device Problem
Fluid/Blood Leak (1250)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Suspect medical device: devices used were reported as "the zenith endovascular graft consists of three modular system composed by a bifurcated aortic main body with suprarenal bare stent aortic fixation and two iliac legs.The zenith had minor modifications, and the second-generation zenith flex aortic main body was used from july 2010." exact device identity is unknown but is presumed to be a tfb or tffb device.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
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Event Description
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In december 2020, cook received a literature article titled "long-term outcomes of endovascular aortic aneurysm repair with the zenith aaa endovascular graft: a single-center study" published online in the japanese journal of radiology in october 2019.The purpose of the article was to present a retrospective study for the long-term results obtained with endovascular abdominal aortic aneurysm (aaa) repair (evar) using the zenith aaa endovascular graft from a single institution.Between august 2007 and december 2013, 95 consecutive patients underwent evar using the zenith aaa endograft at a single institution encompassing three university hospitals.Eighty-one patients were male, 14 were female, and the median age was 77 (range 5195) years.The standard indication for evar at our institution included an aaa larger than 5 cm, or patients with a smaller aaa but with iliac aneurysms larger than 3 cm in maximum diameter.A rapidly increasing aaa sac diameter of more than 5 mm within 6 months and symptomatic aaa in emergency treatment were also included.All patients were at high risk for open repair because of their comorbidities or high age, and had a suitable anatomy for a zenith aaa endovascular graft.Evar was performed in some patients who had exclusion-criteria anatomy, although the physicians essentially complied with instructions for use (ifu).Anatomic exclusion criteria included a proximal neck length < 15 mm, a proximal neck diameter > 32 mm or < 18 mm, a neck angle > 60 degrees, and an angle between the neck and aaa > 45 degrees.The zenith endovascular graft used in the procedures consists of three modular system composed by a bifurcated aortic main body with suprarenal bare stent aortic fixation and two iliac legs.The zenith had minor unspecified modifications, and the second-generation zenith flex aortic main body was used from july 2010.All patients received general anesthesia, and surgical access was via the femoral arteries.The internal iliac arteries were embolized if there were coexisting common or internal iliac artery aneurysms or the common iliac arteries were unstable for distal landing zones.Although we did not routinely embolize branch arteries, such as inferior mesenteric arteries (ima), lumbar arteries, or accessory renal arteries; under certain criteria, some branch arteries with markedly large diameters were embolized based on the operators decision to prevent type 2 endoleaks.These embolizations were performed just before the stent-graft placement during the same evar procedure.The follow-up imaging protocol included non-enhanced, arterial, and delayed venous phase contrast-enhanced aortoiliac computed tomography (ct) at 1 week, 6 months, and 1 year after the procedures and annually thereafter.This report covers six patients that had type 4 endoleaks.No specific information was provided regarding patient identity, patient outcome, endoleak treatment, or follow up procedures for any of these patients.Kawamata, h., tajima, h., ueda, t.Et al.Long-term outcomes of endovascular aortic aneurysm repair with the zenith aaa endovascular graft: a single-center study.Jpn j radiol 38, 7784 (2020).Https://doi.Org/10.1007/s11604-019-00892-6.
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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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Investigation - evaluation: on (b)(6) 2020, cook became aware of a published journal article describing the experiences of a facility in japan in use of zenith aaa endovascular grafts.The article appeared in the japanese journal of radiology and was published on (b)(6) 2019.In the article ¿long-term outcomes of endovascular aortic aneurysm repair with the zenith aaa endovascular graft: a single-center study¿, the authors describe their experiences in using zenith flex aaa endovascular grafts.This event focuses on type 4 endoleaks following implantation of cook devices.No distinguishing information was provided regarding the 6 patients.A review of documentation including the complaint history, drawing, instructions for use (ifu), manufacturing instructions (mi), quality control, and specifications of the device was conducted during the investigation.The complaint devices were not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) was unable to be completed due to a lack of lot information from the user facility.It should be noted that these devices are distributed via one-device lots, giving no indication of nonconforming product in house.As there are adequate inspection activities established and objective evidence that the dhr was fully executed, cook has concluded that the devices were manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The product instructions for use (ifu) [t_zaaaf_rev5] states the following in consideration of the reported failure mode: ¿warnings and precautions -- additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing a large aneurysm, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak.An increase in aneurysm size and/or persistent endoleak or migration may lead to aneurysm rupture.-- 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 conducive to graft migration or endoleak.-- 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 4.2 patient selection, treatment and follow-up -- 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 (<15mm); and inverted funnel shape (greater than 10% increase in diameter over 15mm 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.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 -- 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.-- inadequate fixation of the zenith flex aaa endovascular graft may result in increased risk of migration of the stent graft.Incorrect deployment or migration of the endoprosthesis may require surgical intervention.12.3 abdominal radiographs -- the following views are required: - four films: supine-frontal (ap), cross-table lateral, 30 degree lpo and 30 degree rpo views centered on umbilicus.- record the table-to-film distance and use the same distance at each subsequent examination -- ensure entire device is captured on each single image format lengthwise.If there is any concern about the device integrity (e.G.Kinking, stent breaks, barb separation, relative component migration), it is recommended to use magnified views.The attending physician should evaluate film for device integrity (entire device length including components) using 2-3x magnification visual aid.12.6 additional surveillance and treatment -- additional surveillance and possible treatment is recommended for: - aneurysms with type i endoleak - aneurysms with type iii endoleak - aneurysm enlargement, =5 mm of maximum diameter (regardless of endoleak status) - migration - inadequate seal length consideration for reintervention or conversion to open repair should include the attending physician¿s assessment of an individual patient¿s co-morbidities, life expectancy and the patient¿s personal choices.Patients should be counseled that subsequent reinterventions including catheter based and open surgical conversion are possible following endograft placement.¿ based on the information provided, no products or imaging returned, and the results of our investigation, a definitive root cause for these events was unable to be established.However, it should be noted that endoleaks are a known inherent risk of using these devices.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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Search Alerts/Recalls
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