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On (b)(6) 2014, the electively selected patient with an asymptomatic aneurysm with maximum diameter > 5 cm, which required placement of endovascular stent graft, underwent a procedure and had four cook devices implanted successfully.At day of procedure, the patient presented with a maximum aneurysm diameter of 93 mm and a proximal neck diameter at lowest renal artery was 24 mm.Length from lowest renal artery to start of aneurysm was 30mm.Length from lowest renal artery to aortic bifurcation was 135 mm.Length from aortic bifurcation to iliac bifurcation was 40 mm on the left side and 30 mm on the right side.Outer diameter of iliac at fixation site was 20 mm on the left side and 21 mm on the right side.It was classified as parallel and no plaque/thrombus was present.The procedural imaging revealed patent devices at the conclusion of the procedure and no kinks or endoleaks were observed.The procedure was considered to be successful.A planned standard molding balloon angioplasty was performed as additional procedure.On (b)(6) 2014 (three days post-procedure), the post procedure imaging revealed a maximum aneurysm diameter of 94 mm.Inner lumen diameter of left iliac leg at narrowest segment was 9 mm and inner lumen diameter of right iliac leg at narrowest segment was 10 mm.The devices were patent and intact and there was no migration or kink observed.An endoleak type 2 was observed.On (b)(6) 2014 (230 days post-procedure), the six-month follow-up was performed.The imaging revealed a maximum aneurysm diameter of 84 mm.Inner lumen diameter of left iliac leg at narrowest segment was 12 mm and inner lumen diameter of right iliac leg at narrowest segment was 13 mm.The devices were patent and intact and there was no migration or kink observed.An endoleak type 2 was observed.On (b)(6) 2015 (483 days post-procedure), the 12-month follow-up was performed.The imaging revealed a maximum aneurysm diameter of 85 mm.Inner lumen diameter of left iliac leg at narrowest segment was 10 mm and inner lumen diameter of right iliac leg at narrowest segment was 11 mm.The devices were intact and there was no migration or kink observed.They were also patent except for a stenosis in the left iliac leg.An endoleak type 2 was observed.On (b)(6) 2016 (723 days post-procedure), the two-year follow-up was performed.The imaging revealed a maximum aneurysm diameter of 80 mm.Inner lumen diameter of left iliac leg at narrowest segment was 9 mm and inner lumen diameter of right iliac leg at narrowest segment was 9 mm.The devices were intact and there was no migration, kink or endoleak observed.They were also patent except for a stenosis in the left iliac leg.On (b)(6) 2017 (1115 days post-procedure), the three-year follow-up was performed.The imaging revealed a maximum aneurysm diameter of 77 mm.Inner lumen diameter of left iliac leg at narrowest segment was 10 mm and inner lumen diameter of right iliac leg at narrowest segment was 5 mm.The devices were patent and intact and there was no migration or kink observed.A distal type 1 endoleak on the left side was observed.The patient remains in the study.
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Method codes: 4114, device not returned.Evaluation / investigation: the actual complaint device was not returned.Imaging was provided for review.Without the complaint device, a physical investigation was not able to be completed.A document based investigation has been performed.A review of the provided imaging, instructions for use, and quality control data was conducted.A review of the device history record could not be performed as the lot number of the device was not provided.The three-year follow up computerized tomographic angiography (cta) was provided.A left type 1b endoleak occurred through a 2mm long seal at the distal end of the left zsle inside of calcified funnel shaped, heavily calcified left common iliac aneurysm (cia).The left zsle-24-56 terminated 10mm superior to the left internal iliac artery (iia) origin.The left cia maximal diameter was 21mm at the left iia origin.The following are the impressions of the imaging reviewer.A left type 1b endoleak is confirmed.Given the left iliac gate angulation, the zsle-24-56 was likely extracted by an anterior shift of the zalb inside the large aneurysm sac.The anchoring potential of the left seal zone was limited by its short funnel shape.Given aortic aneurysm shrinkage and the heavily calcified left cia wall, the alternative explanation of left cia aneurysm growth into the seal zone was extremely unlikely.Zsle-24-56 stenosis is not confirmed.Instead, stenosis from angulation and downstream mural thrombus of the left zalb gate is confirmed.The angulation occurred between the flow divider stent and the first zalb ipsilateral gate stent.Right zsle-16-56 stenosis from mural thrombus just downstream the angulation of the proximal right zalb gate is confirmed.Based on the imaging reviewer¿s observation the endoleak was likely a cause of the zsle-24- 56 likely extracted by anterior shift of the zalb inside the large aneurysm sac.There is no mention of device kinking or migration.There is no planning and sizing information.According to the instructions for use (ifu), strict adherence to the zenith spiral-z aaa iliac leg ifu sizing guide is strongly recommended when selecting the appropriate device size.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.Based on current intervention, the most probable causes of this event are human anatomy, medical procedure and/or disease progression related.Each zenith device is shipped with instructions for use (ifu), listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.Per the ifu, do not bend or kink the delivery system.Doing so may cause damage to the delivery system and the zenith spiral-z aaa iliac graft.Do not continue advancing any portion of the delivery system if resistance is felt during advancement of the wire guide or delivery system.Stop and assess the cause of resistance; vessel, catheter or graft damage may occur.Exercise particular care in areas of stenosis, intravascular thrombosis, or in calcified or tortuous vessels.This complaint focuses on the type 1b endoleak that was noted 1115 days after the initial procedure.It was reported that stenosis was noted 483 days after the procedure.However, per the image review zsle-24-56 was not confirmed.A type i endoleak occurs when there is a gap between the graft and the vessel wall at ¿seal zones.¿ the gap allows blood to flow along the side of the graft into the aneurysm sac, which creates pressure within the sac and increases the risk of sac rupture.A possible root cause for type i endoleak could be due to inappropriate sizing, inappropriate deployment procedure followed (deployment of the suprarenal stent in the infrarenal abdominal aorta rather than in suprarenal abdominal aorta), patient¿s anatomical conditions, disease progression (aneurysm neck expansion, increase in the aneurysm diameter) leading to iliac dilation or inappropriate sizing.A three-year follow-up cta image review indicated that the left type ib endoleak occurred through a 2mm long seal at the distal end of the left zsle inside of calcified funnel shaped, heavily calcified left cia aneurysm.The left cia aneurysm was 21mm at the left internal iliac artery (iia) origin.Inferior zalb angulation in the large aneurysm sac required the right zsle to angle 50 degrees posteriorly at the flow divider and the zalb left gate to angle 100degrees posterior to reach the cias.Mural thrombus narrowed the right zsle to 5*7mm and the left gate to 6*11mm, just inferior to each angulation.The gate angulation occurred between the flow divider stent and the first zalb ipsilateral (left) gate stent with downstream mural thrombus of the left zalb gate.Therefore, due to the left iliac gate angulation, the left zsle was likely extracted by an anterior shift of the zalb inside the large aneurysm sac.This along with the short funnel shape of the left zsle seal zone and heavily calcified left cia aneurysm, increased the risk of distal type ib endoleak in the left zsle graft.It was also reported that there was a type ii endoleak noted three days after the procedure until 483 days post procedure.However, no information on endoleak was provided on the 723 and 1115 days follow-up procedure.Type ii endoleaks occur due to patient's anatomical conditions: patent inferior mesenteric artery, number of patent lumbar arteries, and maximum aneurysm diameter significantly increase the risk for type ii endoleaks after evar.Additionally, it was reported that the patient had pre-existing condition of hyperlipidemia, systemic disease and is a current smoker.It is possible that the patient anatomy would have increased the risk of type ib endoleak in the left iliac leg.The image review indicates that the left type ib endoleak occurred at the distal end of the left zsle inside of calcified funnel shaped and heavily calcified left cia aneurysm.Therefore, the likely cause for the type ib endoleak in the left zsle is adverse event related to patient condition.In addition, the main body used was short relative to the length of the infrarenal abdominal aorta and the left zsle terminated 10mm superior to the iia.It is possible that using a longer mainbody would have reduced the risk of left zsle extraction into the mainbody would have reduced and adequate left zsle seal would have obtained reducing the risk of type ib endoleak in the left.A second possible cause is adverse event related to procedure.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded a change is not required, thus no risk reduction activities are required at this time.The appropriate internal personnel have been notified and we 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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