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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 Problems
Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562); Migration (4003)
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| Patient Problem
Abdominal Pain (1685)
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| Event Date 07/29/2022 |
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Event Type
Injury
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Manufacturer Narrative
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Device name: device is an unknown tffb zenith flex aaa endovascular graft bifurcated main body.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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It was reported that stent separation in the zenith flex aaa endovascular graft bifurcated main body lead to graft migration and a type 1a endoleak in an 81-year-old male patient.As a result, an additional procedure was required to re-align and seal off the aneurysm.The initial endovascular abdominal aortic aneurysm repair (evar) procedure was estimated to have occurred 14 years ago.The patient presented to a physician after becoming symptomatic with abdominal pain.An initial scan reflected a leak, as the suprarenal barb separated from the first sealing stent.This caused the graft to migrate, leading to a type 1a endoleak.Per the physician, explantation of the device was not an option due to the patient's age.As the situation was non-emergent, the patient was scheduled for a repair.The secondary intervention took place on (b)(6) 2022.The physician, who had their own fda investigational device exemption (ide), modified a cook thoracic graft (tx2) to create fenestrations for the iliac artery, superior mesenteric artery (sma) and the right renal artery.The physician also re-aligned the limbs on the right side with aui and zsle grafts.The hypogastric artery on the left side was "out," as it was occluded.The physician performed final run imaging that indicated no leak was present.Additional information regarding event and patient details has been requested, but is currently unavailable.
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Event Description
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Additional information was provided on (b)(6) 2022 indicating that the left iliac leg graft was occluded before the reintervention procedure on (b)(6) 2022.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5 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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Manufacturer Narrative
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Investigation ¿ evaluation area representative informed cook medical on 29jul2022 about an incident regarding stent separation of a zenith flex aaa endovascular graft bifurcated main body which lead to graft migration and a type 1a endoleak in an 81-year-old male patient.As a result, an additional procedure was required to re-align and seal off the aneurysm.The initial endovascular abdominal aortic aneurysm repair (evar) procedure was estimated to have occurred 14 years ago.The patient presented to a physician after becoming symptomatic with abdominal pain.An initial scan reflected a leak, as the suprarenal barb separated from the first sealing stent.This caused the graft to migrate, leading to a type 1a endoleak.Per the physician, explanation of the device was not an option due to the patient's age.As the situation was non-emergent, the patient was scheduled for a repair.The secondary intervention took place on 29jul2022.The physician, who had their own fda investigational device exemption (ide), modified a cook thoracic graft (tx2) to create fenestrations for the iliac artery, superior mesenteric artery (sma) and the right renal artery.The physician also re-aligned the limbs on the right side with aui and zsle grafts.The hypogastric artery on the left side was "out," as it was occluded before the placement of the aui.A still image provided by the site clearly shows the suprarenal stent was fractured.Pr371884 was opened to capture the fracture of the suprarenal stent.Pr373506 was opened to capture the occlusion of the left iliac leg graft.This investigation, pr371267 will focus on the type 1a endoleak with suprarenal stent separation.A review of the complaint history, documentation, drawing, quality control procedures, specifications, manufacturing instructions (mi), and instructions for use (ifu) were conducted during the investigation.The complaint device was 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.The customer did not provide the lot number for the complaint devices.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 7 ¿zenith flex aaa endovascular graft with the h&l-b one-shot introduction system,¿ provides the following information to the user related to the reported failure mode: 4 warnings and precautions 4.1 general ¿ additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing an enlarging 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.¿ 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.Lengths ¿ 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 ¿ 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: ¿ endoleak ¿ endoprosthesis: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; barb separation and corrosion 7 patient selection and treatment 7.1 individualization of treatment the risks and benefits should be carefully considered for each patient before use of the zenith flex aaa endovascular graft.Additional considerations for patient selection include but are not limited to: ¿ patient's anatomical suitability for endovascular repair ¿ non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm: ¿ with a length of at least 15 mm, ¿ with a diameter measured outer wall to outer wall of no greater than 32 mm and no less than 18 mm, ¿ with an angle less than 60 degrees relative to the long axis of the aneurysm, and ¿ with an angle less than 45 degrees relative to the axis of the suprarenal aorta ¿ freedom from significant femoral/iliac artery occlusive disease that would impede flow through the endovascular graft the final treatment decision is at the discretion of the physician and patient.8 patient counseling information the long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.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.Pre-implant determinants verify from pre-implant planning that the correct device has been selected.Determinants include: 1.Femoral artery selection for introduction of the main body system (i.E., define respective contralateral and ipsilateral iliac arteries).2.Angulation of aortic neck, aneurysm, and iliac arteries.3.Quality of the aortic neck.4.Diameters of infrarenal aortic neck and distal iliac arteries.5.Distance from renal arteries to the aortic bifurcation.6.Length from the aortic bifurcation to the internal iliac arteries/attachment site(s).7.Aneurysm(s) extending into the iliac arteries may require special consideration in selecting a suitable graft/artery interface site.8.Consider the degree of vascular calcification.Final angiogram 1.Position angiographic catheter just above the level of the renal arteries.Perform angiography to verify that the renal arteries are patent and that there are no endoleaks.Verify patency of internal iliac arteries.2.Confirm there are no endoleaks or kinks and verify position of proximal gold radiopaque markers.Remove the sheaths, wires, and catheters.The imaging review was completed by dr.Nabeel r.Rana, md on 01sep2022.A postoperative ct study and angiography images were provided for evaluation.The following is the impression of the review: impression: 1.A presumed infrarenal aaa was previously treated using a tffb main body graft and bilateral tfle iliac legs.Based on this ct, it was likely a tffb-32-96 device.2.The current ct (reportedly 14 years postop) shows partial component separation of the suprarenal stent from the proximal graft of the tffb device along the left anterolateral segment.The suprarenal stent remains attached along the posterior graft, but there is a 7 mm gap between components anteriorly.The subsequent angiogram procedure shows an interval focal fracture of the suprarenal stent with partial unraveling.3.There is severe aneurysmal dilation of the pararenal aorta with a maximum diameter of 63 mm at the level of the rra.The aneurysm sac begins between the celiac trunk and sma and continues through the infrarenal aorta.This is basically an extent iv taaa.Preop imaging is not provided so it cannot be determined if the anatomy was within ifu at the time of initial repair.4.The proximal tffb graft is within the aneurysmal segment with no graft wall apposition and a large type 1a endoleak.The graft begins 22 mm below the rra.On the present study, the type 1a endoleak is not due to the component separation or possible graft migration.It is due to aneurysmal dilation of the pararenal aorta with no infrarenal neck.5.The sequence of causality cannot be determined from the single study provided.One possibility is the component separation led to a focal type 1a endoleak with progressive dilation of the proximal neck due to sac perfusion and subsequent graft migration due to loss of graft wall apposition.The more likely scenario (based on the severity and extent of proximal neck dilation) is progression of aneurysmal disease of the pararenal aorta with loss of graft wall apposition resulting in shearing forces at the suprarenal stent junction causing partial component separation and, possibly, concomitant migration.6.Finally, it cannot be determined if there was adequate anatomy at the time of initial repair with an infrarenal neck and adequate proximal seal, or if the graft was placed low initially rather than migrating.Preop or early postop imaging would be needed to delineate these possibilities.7.It is not clear if the focal fracture of the suprarenal stent on the angiogram images occurred during the angiogram procedure or in the interval following the ct study, as there is no fracture seen on the ct.If the latter, this is likely the result of partial stent fixation in the aortic wall with continued shearing forces on the free-floating and partially separated graft ultimately yielding to a fracture and partial unraveling.8.Incidentally, there is complete occlusion of the left tfle iliac leg, which is positioned much higher than the right tfle leg well above the flow divider within the tffb graft.Based on the information provided and the results of the investigation, a definitive cause for the failure could not be determined.Per image reviewer, the type 1a endoleak is not due to the component separation or possible graft migration.It is due to aneurysmal dilation of the pararenal aorta with no infrarenal neck.Two possible causes were offered for the type 1a endoleak.The first possibility is the component separation led to a focal type 1a endoleak with progressive dilation of the proximal neck due to sac perfusion and subsequent graft migration due to loss of graft wall apposition.The more likely scenario (based on the severity and extent of proximal neck dilation) is progression of aneurysmal disease of the pararenal aorta with loss of graft wall apposition resulting in shearing forces at the suprarenal stent junction causing partial component separation and, possibly, concomitant migration.While a definitive cause for the failure could not be determined a likely contributing factor was disease progression.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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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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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: h6 - annex a.Investigation ¿ evaluation.Area representative informed cook medical on 29jul2022 about an incident regarding stent separation of a zenith flex aaa endovascular graft bifurcated main body which lead to graft migration and a type 1a endoleak in an 81-year-old male patient.As a result, an additional procedure was required to re-align and seal off the aneurysm.The initial endovascular abdominal aortic aneurysm repair (evar) procedure was estimated to have occurred 14 years ago.The patient presented to a physician after becoming symptomatic with abdominal pain.An initial scan reflected a leak, as the suprarenal barb separated from the first sealing stent.This caused the graft to migrate, leading to a type 1a endoleak.Per the physician, explanation of the device was not an option due to the patient's age.As the situation was non-emergent, the patient was scheduled for a repair.The secondary intervention took place on (b)(6) 2022.The physician, who had their own fda investigational device exemption (ide), modified a cook thoracic graft (tx2) to create fenestrations for the iliac artery, superior mesenteric artery (sma) and the right renal artery.The physician also re-aligned the limbs on the right side with aui and zsle grafts.The hypogastric artery on the left side was "out," as it was occluded before the placement of the aui.A still image provided by the site clearly shows the suprarenal stent was fractured.(b)(4).Was opened to capture the fracture of the suprarenal stent.(b)(4).Was opened to capture the occlusion of the left iliac leg graft.This investigation, (b)(4).Will focus on the type 1a endoleak with suprarenal stent separation.A review of the complaint history, documentation, drawing, quality control procedures, specifications, manufacturing instructions (mi), and instructions for use (ifu) were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, medical imaging was provided by the customer for expert review.A presumed infrarenal aaa was previously treated using a tffb main body graft and bilateral tfle iliac legs.Based on this ct, it was likely a tffb-32-96 device.The current ct (reportedly 14 years postop) shows partial component separation of the suprarenal stent from the proximal graft of the tffb device along the left anterolateral segment.The suprarenal stent remains attached along the posterior graft, but there is a7 mm gap between components anteriorly.The subsequent angiogram procedure shows an interval focal fracture of the suprarenal stent with partial unraveling.There is severe aneurysmal dilation of the pararenal aorta with a maximum diameter of 63 mm at the level of the rra.The aneurysm sac begins between the celiac trunk and sma and continues through the infrarenal aorta.This is basically an extent iv taaa.Preop imaging is not provided so it cannot be determined if the anatomy was within ifu at the time of initial repair.The proximal tffb graft is within the aneurysmal segment with no graft wall apposition and a large type 1a endoleak.The graft begins 22 mm below the rra.On the present study, the type 1a endoleak is not due to the component separation or possible graft migration.It is due to aneurysmal dilation of the pararenal aorta with no infrarenal neck.The sequence of causality cannot be determined from the single study provided.One possibility is the component separation led to a focal type 1a endoleak with progressive dilation of the proximal neck due to sac perfusion and subsequent graft migration due to loss of graft wall apposition.The more likely scenario (based on the severity and extent of proximal neck dilation) is progression of aneurysmal disease of the pararenal aorta with loss of graft wall apposition resulting in shearing forces at the suprarenal stent junction causing partial component separation and, possibly, concomitant migration.Finally, it cannot be determined if there was adequate anatomy at the time of initial repair with an infrarenal neck and adequate proximal seal, or if the graft was placed low initially rather than migrating.Preop or early postop imaging would be needed to delineate these possibilities.It is not clear if the focal fracture of the suprarenal stent on the angiogram images occurred during the angiogram procedure or in the interval following the ct study, as there is no fracture seen on the ct.If the latter, this is likely the result of partial stent fixation in the aortic wall with continued shearing forces on the free-floating and partially separated graft ultimately yielding to a fracture and partial unraveling.Incidentally, there is complete occlusion of the left tfle iliac leg, which is positioned much higher than the right tfle leg well above the flow divider within the tffb graft.Additionally, 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) could not be performed due to lack of lot information from the user facility.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product ifu, t_zaaaf36_rev 7 ¿zenith flex aaa endovascular graft with the h&l-b one-shot introduction system,¿ provides the following information to the user related to the reported failure mode: 4 warnings and precautions.4.1 general.Additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing an enlarging 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.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.Lengths: 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 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: endoleak endoprosthesis: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; barb separation and corrosion 7 patient selection and treatment 7.1 individualization of treatment the risks and benefits should be carefully considered for each patient before use of the zenith flex aaa endovascular graft.Additional considerations for patient selection include but are not limited to: patient's anatomical suitability for endovascular repair non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm: with a length of at least 15 mm, with a diameter measured outer wall to outer wall of no greater than 32 mm and no less than 18 mm, with an angle less than 60 degrees relative to the long axis of the aneurysm, and with an angle less than 45 degrees relative to the axis of the suprarenal aorta freedom from significant femoral/iliac artery occlusive disease that would impede flow through the endovascular graft the final treatment decision is at the discretion of the physician and patient.8 patient counseling information the long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.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.Pre-implant determinants verify from pre-implant planning that the correct device has been selected.Determinants include: 1.Femoral artery selection for introduction of the main body system (i.E., define respective contralateral and ipsilateral iliac arteries).2.Angulation of aortic neck, aneurysm, and iliac arteries.3.Quality of the aortic neck.4.Diameters of infrarenal aortic neck and distal iliac arteries.5.Distance from renal arteries to the aortic bifurcation.6.Length from the aortic bifurcation to the internal iliac arteries/attachment site(s).7.Aneurysm(s) extending into the iliac arteries may require special consideration in selecting a suitable graft/artery interface site.8.Consider the degree of vascular calcification.Final angiogram 1.Position angiographic catheter just above the level of the renal arteries.Perform angiography to verify that the renal arteries are patent and that there are no endoleaks.Verify patency of internal iliac arteries.2.Confirm there are no endoleaks or kinks and verify position of proximal gold radiopaque markers.Remove the sheaths, wires, and catheters.Based on the information provided and the results of the investigation, cook could not determine a definitive cause for the failure.It was noted the ct showed partial component separation of the suprarenal stent from the proximal graft of the tffb device along the left anterolateral segment.The suprarenal stent remained attached along the posterior graft with a 7 mm gap between components anteriorly.On the subsequent angiogram there was a new fracture of the suprarenal stent.A possible cause of the fracture of the stent was observed via images in which it is not clear if the focal fracture of the suprarenal stent on the angiogram occurred during the angiogram procedure or in the interval following the ct study, as there is no fracture seen on the ct.If the latter, this was likely the result of partial stent fixation in the aortic wall with continued shearing forces on the free-floating and partially separated graft ultimately yielding to a fracture and partial unraveling.Another possible contributing factor was disease progression causing aneurysmal dilation of the pararenal neck leading to partial component separation which in turn caused stress on the free-floating graft leading to the fracture.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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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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Search Alerts/Recalls
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