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It was reported that a type 1b endoleak was identified on the left zenith flex with spiral-z technology aaa endovascular graft iliac leg during a fenestrated endovascular abdominal aortic aneurysm repair (fevar) procedure on a 67-year-old male patient.Pre-procedure imaging was completed on (b)(6)2024, 112 days prior to the procedure.The proximal sealing zone did not have any occlusive disease or calcification.Thrombus was not present in the proximal sealing zone.The proximal sealing zone was described as parallel.The right common iliac artery, left common iliac artery, right external iliac artery, left external iliac artery, right femoral artery, left formal artery did not have any calcification or occlusive disease.The iliac arteries were not tortuous.The aorta diameter at the location of the maximum aneurysm diameter (outer-wall to outer-wall) was 63 mm.The length of the suitable proximal seal zone was 50 mm.The diameter of the aorta at location of maximum diameter over length of proximal seal zone (outer-wall to outer-wall) was 26 mm.The diameter of aorta at the location of minimum diameter over length of proximal seal zone (outer-wall to outer-wall) was 24 mm.The % change in seal zone diameter throughout the length of the seal zone was 7.69.The length from lowest targeted vessel (most inferior aspect) to the aortic bifurcation was 143 mm.The angulation between infra-renal aorta and aneurysm center line was 0 degrees.The maximum angulation above the infra-renal aorta (within region of zfen and delivery system was 6 degrees.The percentage of stenosis was less than 50% for the celiac, sma, right renal, and left renal arteries.The diameter of the celiac artery at the location of intended distal landing zone (outer wall to outer-wall) was 6.9 mm.The length from the celiac artery ostium to the first major bifurcation was 15 mm.The diameter of the superior mesenteric artery at the location of intended distal landing zone (outer wall to outer-wall) was 7.0 mm.The length from the superior mesenteric artery ostium to the first major bifurcation was 25 mm.The diameter of the left renal artery at the location of intended distal landing zone (outer wall to outer-wall) was 6.2 mm.The length from the left renal ostium to the first major bifurcation was 28 mm.The length from the ostium of the right iliac artery to the first major bifurcation was 38 mm.The diameter of the right iliac artery at the location of the intended distal landing zone (outer wall to outer wall) was 13 mm.The length from the ostium of the left iliac artery to the first major bifurcation was 40 mm.The diameter of the left iliac artery at the location of the intended distal landing zone (outer wall to outer wall) was 13 mm.The location of the intended distal landing zone maintained the patency of the internal iliac arteries.No stenosis was present in the left or right iliac artery.Per procedural notes: the patient underwent a fenestrated endovascular aortic repair (fevar) procedure under general anesthesia on (b)(6)2024.Patient admitted: 05:55 procedural time (24-hour clock): time arrives in room: 07:05 administration of anesthesia: 07:27 time of first incision or arterial puncture: 08:26 initial catheter inserted: 08:44 final catheter removed 11:08 all incision closures completed: 12:19 time patient leaves room: 12:39 estimated blood loss: 250 cc during the procedure, the patient did not receive any blood bank products.Total contrast volume used during the procedure: 50 ml contrast concentration: 50 ml total fluoroscopy time (from incision to removal): 62 minutes radiation dose (total during procedure): 8876 mgy.Total procedure time was 135 minutes.Transferred to hpj033: 12:39 transferred out of hpj033: 15:04 patient discharged: 15:28 anesthesia: get patient was brought to the operative theater placed in the supine position after adequate general anesthesia was given.The patient's abdomen and bilateral groins were prepped and draped in usual sterile fashion.Bilateral groins were accessed with micropuncture systems under ultrasound guidance.These were exchanged for stiff competitor guide wires and two suture mediated closure devices were used to pre close each groin.Eleven cm long 8f marker-tipped sheaths were then placed over the stiff competitor guide wires.Heparin was given and acts were checked at half hour intervals.On the right-side, a competitor guide wire was placed in the descending thoracic aorta.The 8fr sheath was removed and an 18fr sheath was brought up to the aortic bifurcation.At this point a competitor wire was placed into the proximal thoracic aorta on the left.A pigtail catheter was placed up the right side into the thoracic aorta.An aortogram revealed a large fusiform juxtarenal aneurysm, a solitary left renal, celiac and superior mesenteric arteries.The aortoiliac system was patent with bilateral external iliac artery stents.The fenestrated proximal main body was oriented outside the body under fluoroscopy.It was exchanged with the 8fr sheath on the left side over the competitor wire.It was brought up to the level of the celiac and the superior mesenteric artery and confirmed the orientation.It was deployed without difficulty.The proximal antibody was cannulated using a vanschie5 and a stiff competitor wire and the 18fr sheath was brought up into the distal portion of the proximal main body.Using vanschie4 catheter, the celiac artery was cannulated.A stiff wire was advanced towards the hepatic.A quick cross catheter was used to place it into the hepatic.A rosen wire was placed at the hepatic.Using a vs1 catheter, the superior mesenteric artery was accessed with a stiff wire.The vs1 catheter tract into the superior mesenteric artery.Angiogram of the superior mesenteric artery revealed a widely patent vessel and a rosen was placed into the superior mesenteric artery.A 7fr sheath was now brought up into the superior mesenteric artery.Using a vs1 catheter the left renal artery was accessed.Using a stiff competitor wire the catheter was placed into the distal portion of the renal artery.This was exchanged out for the rosen wire through the vs1.A 6fr ansell was brought up into the proximal portion of the renal artery.Once the orientation was correct and placement of the superior mesenteric artery sheath and left renal sheath, the constraining wire was removed.As well as the two out of trickle wires for the proximal fixation and distal fixation.This was balloon molded with a coda balloon proximally before any deployment of the stents.Once balloon molding was done a competitor stent was placed in the left renal.There was reported difficulty with adequate overlap into the aorta.The proximal portion was flared with a doppler probe balloon.A competitor stent was placed into the proximal superior mesenteric artery and was flared with a 10 mm balloon.A 7fr ansell was brought up into the celiac and a competitor stent was deployed without difficulty.Upon trying to flare of the proximal portion, great difficulty was experienced when tracking a balloon and ultimately a competitor balloon was used for adequate flaring.The universal distal main body was opened and was oriented on fluoroscopy outside the patient body.The graft was brought the left side and deployed without difficulty.Using a kumpe catheter and a stiff competitor wire, the contralateral gate was cannulated.Without difficulty, a mild wire was placed, and the location of the hypogastric artery was confirmed via angiogram.A 16 x 37 mm graft was placed on the contralateral side deployed without difficulty.Deployment of the distal main body on the ipsilateral side was completed and the wires and inner cannula were removed.Using a 16 x 54 limb, the user placed the graft just proximal to the left hypogastric.All junction points and seals were balloon molded with a coda balloon, except for the proximal.An aortogram performed revealed widely patent left renal, superior mesenteric artery and celiac artery.There appeared to be type ii endoleak coming from the lumbar as well as the inferior mesenteric artery.A type lb endoleak was also identified.The area of the endoleak was further balloon molded with a coda balloon, as well as a competitor angiographic balloon.Upon further angiographic inspection, the type ib was further minimized, and appeared to be the just result of a type ii endoleak.At this point all sheaths and catheters were removed.The suture mediated closure devices were cinched up.There is noted to be hemostasis.On the left requiring additional placement of another suture mediated closure devices.Ultrasound revealed no pseudoaneurysm or hematoma and adequate flow.The patient had pulses distally.The patient was awoken and moved everything to the par in stable condition.The right common femoral artery was cut down for ipsilateral and contralateral access.Successful deployment in all intended locations for all devices was achieved.All delivery system devices were able to be withdrawn successfully.No unanticipated corrective interventions were required during the procedure.No bridging stents were unable to be delivered or deployed due to being stripped off the balloon.The following cook devices were implanted during the procedure: cook zenith fenestrated device: there was no difficulty flushing the introducer system and removing the release wires.The clinician was able to adequately visualize the device from the start to the end of the implant.There was no difficulty cannulating the fenestrations or retracting the sheath.Cook universal distal body was placed using ipsilateral access the amount of overlap with the preceding component was 4 stents.There were no difficulties in removing the release wires or retracting the sheath.The clinician was able to adequately visualize the device from the start to the end of the implant.Unknown device placed in the right common iliac artery.The amount of overlap with the preceding component was 1.5 stents.Cook zenith flex with spiral-z technology aaa endovascular graft iliac leg was placed in the left common iliac artery via ipsilateral access.The amount of overlap with the preceding component was 2.0 stents.From the contralateral access, a competitor¿s stent was placed in the left renal artery.12 atmospheres (atm) of inflation pressure were used to expand the bridging stent.The stent was flared.A competitor¿s 8 x 2 balloon was inflated to 10 atm for flaring.No issues were encountered during flaring.The clinician was able to adequately visualize the bridging stent from the start to the end of the implant.From the contralateral access, a competitor¿s stent was placed in the superior mesenteric artery (sma).12 atm of inflation pressure was used to expand the bridging stent.The stent was flared.A competitor¿s 10 x 2 balloon was inflated to 10 atm for flaring.No issues were encountered during flaring.The clinician was able to adequately visualize the bridging stent from the start to the end of the implant.From the contralateral access, a competitor¿s stent was placed in the superior mesenteric artery (sma).10 atm of inflation pressure was used to expand the bridging stent.The stent was flared.A competitor¿s 2 x10 balloon was inflated to 8 atm for flaring.No issues were encountered during flaring.The clinician was able to adequately visualize the bridging stent from the start to the end of the implant.Additional cook ancillary devices were used during the procedure.No device deficiencies were identified involving the cook ancillary devices.No adverse events were identified involving the cook ancillary devices.The device performed as intended and successful access of the intended vasculature was achieved.Procedural imaging (cone beam computed tomography (ct) without contrast and an angiography scan) were completed on (b)(6)2024.All of the devices were patent at the end of the procedure.There was no stenosis in any vessel greater than 50% identified.A type ii endoleak was present in the inferior mesenteric and lumbar arteries.Resumption of oral fluid intake occurred on (b)(6)2024.The patient was discharged on (b)(6)2024.An in-person post procedure clinical assessment was completed on (b)(6)2024, 26 days post procedure.The patient was taking antithrombotic medications.Since the study procedure the patient has not had any significant medical problems or been hospitalized for any reason.A follow up ct was completed on (b)(6)2024, 26 days post procedure.There was no stenosis in any vessel greater than 50% identified in any treated vessel.The endograft devices were all patent.Visceral vessel patency: the celiac artery native vessel was patent and was patent within the stent.The sma native vessel was patent and was patent within the stent.No stent was placed in the right renal artery.The left renal artery native vessel was patent and was patent within the stent.Other targeted vessels were not patient within the stent, but the native vessel was patent.The other targeted vessel was not identified.The aorta diameter at the location of the maximum aneurysm diameter (outer-wall to outer-wall) was 54 mm.The maximum aneurysm diameter had not increased more than 5 mm when compared to the post procedure ct measurement.The diameter of the right common iliac artery at location of maximum diameter (outer-wall to outer-wall) was 14 mm.The diameter of the left common iliac artery at location of maximum diameter (outer-wall to outer-wall) was 14 mm.A type ii endoleak was present in the inferior mesenteric and lumbar arteries.There was no evidence of device integrity issues.No separation of components had occurred.There was no evidence of device migration more than or equal to 10 mm.There was no evidence of device thrombus within a study device.An in person follow clinical assessment was completed on (b)(6)2024, 188 days post procedure.The patient was taking antithrombotic medications.Since the study procedure the patient had a significant medical problem or was hospitalized.A follow up ct was completed on (b)(6)2024, 188 days post procedure.There was no stenosis in any vessel greater than 50% identified in any treated vessel.The endograft devices were all patent.Visceral vessel patency: the celiac artery native vessel was patent and was patent within the stent.The sma native vessel was patent and was patent within the stent.No stent was placed in the right renal artery.The left renal artery native vessel was patent and was patent within the stent.No stents were placed in the other targeted vessels.The aorta diameter at the location of the maximum aneurysm diameter (outer-wall to outer-wall) was 63 mm.The maximum aneurysm diameter had not increased more than 5 mm when compared to the post procedure ct measurement.The diameter of the right common iliac artery at location of maximum diameter (outer-wall to outer-wall) was 18 mm.The diameter of the left common iliac artery at location of maximum diameter (outer-wall to outer-wall) was 18 mm.A type 1b endoleak on the left iliac leg graft was identified.A type ii endoleak was also present.There was no evidence of device integrity issues.No separation of components had occurred.There was no evidence of device migration more than or equal to 10 mm.There was no evidence of device thrombus within a study device.On (b)(6)2024, 188 days post procedure the type 1b endoleak on the left iliac leg graft was indicated to require treatment.However, treatment had not been provided as of the date of the report.
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Correction: h6 - annex a.Investigation ¿ evaluation.It was reported that a type 1b endoleak was identified on the left zenith flex with spiral-z technology aaa endovascular graft iliac leg during a fenestrated endovascular abdominal aortic aneurysm repair (fevar) procedure on a 67-year-old male patient.On (b)(6) 2024, procedure imaging was completed.The proximal sealing zone did not have any occlusive disease or calcification.Thrombus was not present in the proximal sealing zone.The proximal sealing zone was described as parallel.The right common iliac artery left common iliac artery, right external iliac artery, left external iliac artery, right femoral artery, left formal artery did not have any calcification or occlusive disease.The iliac arteries were not tortuous.The aorta diameter at the location of the maximum aneurysm diameter (outer-wall to outer-wall) was 63 mm.The length of the suitable proximal seal zone was 50 mm.The diameter of the aorta at location of maximum diameter over length of proximal seal zone (outer-wall to outer-wall) was 26 mm.The diameter of aorta at the location of minimum diameter over length of proximal seal zone (outer-wall to outer-wall) was 24 mm.The % change in seal zone diameter throughout the length of the seal zone was 7.69.The length from lowest targeted vessel (most inferior aspect) to the aortic bifurcation was 143 mm.The angulation between infra-renal aorta and aneurysm center line was 0 degrees.The maximum angulation above the infra-renal aorta (within region of zfen+ and delivery system was 6 degrees.The percentage of stenosis was less than 50% for the celiac, sma, right renal, and left renal arteries.The location of the intended distal landing zone maintained the patency of the internal iliac arteries.No stenosis was present in the left or right iliac artery.On 07jun2024, the patient underwent an endovascular procedure as part of the study: 17-07 zenith fenestrated endovascular graft clinical study.During the procedure, the operative report had noted "there appeared to be type ii endoleak coming from the lumbar as well as the ima.There appeared to be a type ib endoleak.This was further balloon molded with a coda balloon as well as angiographic balloon of the 14 mm armada.Upon further angiographic inspection a type ib was further minimized and appeared to be the just result of a type ii endoleak." on (b)(6) 2024, 188 days post procedure the type 1b endoleak on the left iliac leg graft was indicated to require treatment.On (b)(6) 2025, percutaneous secondary intervention was completed to treat the type ib endoleak at the left iliac leg graft.The focus of this investigation is the type ib endoleak on the left iliac leg graft.The event was considered not related to a device and not related to the procedure.The site added that the "patient had a potential large iliac/longer than originally though, and type ib occurred" was another condition/circumstance that caused or contributed to this event.There was an additional zsle-20-56-zt placed proximally to the bifurcation of the iliac.The core lab's 6m ct analysis: there was 0% stenosis of the celiac, sma, lra within stent and native vessel.The endograft devices were patent and there was 0% stenosis of the bilateral iliac leg grafts.There was no separation of components, evidence of migration, evidence of device integrity issues, or evidence of thrombus within a study device.There was a type ii endoleak.Reviews of the documentation including the complaint history, device history record, drawing, quality control procedures and instructions for use (ifu) of the device were completed during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination could not be performed.However, medical imagine was provided for expert image review.The image reviewer found that the left zsle-16-39 type 1b endoleak was confirmed.The endoleak was present at implantation, suggested at one month, and definite at six months.Implantation of a zsle-16-39 rather than the planning and sizing worksheet specified zsle-16-56 resulted in an under sized sealing stent that permitted the endoleak at implantation and follow up.A type ii endoleak from lumbar arteries was also present.On cta follow up, this endoleaks direction relative to the sac cannot be determined.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that appropriate inspections are in place relative to the reported device failure.A review of the device history record (dhr) for the device found no nonconformances or other complaints associated with the final product lot number.Cook was able to review product labeling.The device was packaged with ifu t_zaaasz_rev4.The ifu includes the following, warnings, precautions, and instructions for proper placement of the device.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 patient experiencing enlarging aneurysms, 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 ¿ successful patient selection requires specific imaging and accurate measurements; please see section 4.3, pre-procedure measurement techniques and imaging.4.3 pre-procedure measurement techniques and imaging ¿ clinical experience indicates that contrast-enhanced spiral computed tomographic angiography (cta) with 3-d reconstruction is the strongly recommended imaging modality to accurately assess patient anatomy prior to treatment with the zenith spiral-z aaa iliac leg.If contrast-enhanced spiral cta with 3-d reconstruction is not available, the patient should be referred to a facility with these capabilities.Lengths ¿ 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., endoleak, 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 or stent fracture) 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 spiral-z aaa iliac leg ifu sizing guide is strongly recommended when selecting the appropriate device size (table 10.5.1).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 spiral-z aaa iliac leg within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the internal iliac arteries.¿ fluoroscopy should be used during introduction and deployment to confirm proper operation of the delivery system components, proper placement of the graft, and desired procedural outcome.5.2 potential adverse events ¿ aneurysm enlargement ¿ aneurysm rupture and death ¿ claudication (e.G., buttock, lower limb) ¿ endoleak ¿ endoprosthesis: improper component placement; incomplete component deployment; component migration; component separation from another graft component; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; and corrosion ¿ surgical conversion to open repair 7.1 individualization of treatment additional considerations for patient selection include, but are not limited to: ¿ patient¿s age and life expectancy ¿ co-morbidities (e.G., cardiac, pulmonary or renal insufficiency prior to surgery, morbid obesity) ¿ patient¿s suitability for open surgical repair ¿ patient¿s ability to tolerate general, regional or local anesthesia ¿ iliofemoral access vessel size and morphology (minimal thrombus, calcification and/or tortuosity) should be compatible with vascular access techniques and accessories of the delivery profile of a 14 french to 16 french vascular introducer sheath 8 patient counseling information ¿ 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 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.¿ patients should be counseled on the importance of adhering to the follow-up schedule, both during the first year and at yearly 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.At a minimum, annual imaging and adherence to routine postoperative follow-up requirements is required and should be considered a life-long commitment to the patient¿s health and well-being.¿ physicians must advise all patients that it is important to seek prompt medical attention if they experience signs of limb occlusion include pain in the hip(s) or leg(s) during walking or at rest or discoloration or coolness of the leg.Aneurysm rupture may be asymptomatic, but usually presents as: pain; dizziness; fainting; rapid heartbeat or sudden weakness.Physicians should refer patient 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 (see section 5.1, observed adverse events and section 5.2, potential adverse events).The physician should complete the patient i.D.Card and give it to the patient so he/she can carry it with him/her visits additional health practitioners, particularly for any additional diagnostic procedures (e.G., mri).12 imaging guidelines and postoperative follow-up 12.1 general ¿ 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 additional follow-up.¿ patients should be counseled on the importance of adhering to the follow-up schedule, both during the first year and at yearly 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.¿ physicians should evaluate patients on an individual basis and prescribe follow-up relative to the needs and circumstances of each individual patient.The minimum requirement for patient follow-up (described in the instructions for use for the zenith aaa device that was used) should be maintained even in the absence of clinical symptoms (e.G., pain, numbness, weakness).Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the stent graft) should receive follow-up at more frequent intervals.¿ the combination of contrast and non-contrast ct imaging provides information on aneurysm diameter change, endoleak, patency, tortuosity, progressive disease, fixation length and other morphological changes.¿ duplex ultrasound imaging may provide information on device integrity (e.G., separation between components, stent fracture).After review of the ifu, cook has concluded the device labeling contains appropriate warnings, precautions and instructions to the user related to the reported failure.Evidence provided by the customer, complaint history, device history record, device failure analysis, manufacturing documents, and verification testing, suggests that the device was manufactured to specification.There is no evidence of nonconforming devices in house or in the field.Based on the information provided, an expert review of imaging provided, and the results of our investigation, it was concluded that the medical procedure likely contributed to the event.The image reviewer stated, ¿implantation of a zsle-16-39 rather than the planning and sizing worksheet specified zsle-16-56 resulted in an undersized sealing stent that permitted the endoleak at implantation and follow up.¿ in addition, the ifu states ¿strict adherence to the zenith spiral-z aaa iliac leg ifu sizing guide is strongly recommended when selecting the appropriate device size.Inaccurate placement and/or incomplete sealing of the zenith spiral-z aaa iliac leg within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the internal iliac arteries.¿ per the risk assessment no further action is required.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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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