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Blank fields on this form indicate the information is unknown or unavailable.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 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 or that a death or serious injury occurred; nor is it admission 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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Cook was informed that a patient participating in a study had a type 1b endoleak on the zenith flex with spiral-z technology aaa endovascular graft iliac that was identified in the computed tomography scan completed three days post operative.The patient had several planned staged procedures.On (b)(6) 2023, the first staged procedure, a thoracic endovascular aortic repair (tevar) was completed under general anesthesia.A proximal aortic device, cook zenith alpha thoracic endovascular graft (zta) proximal tapered component (rpn: zta-pt-40-36-167) was implanted in the patient.The proximal size of the aortic device was 40 mm.The distal size of the aortic device was 36 mm and the length was 167 mm.There were no technical difficulties in the delivery and deployment of this device.The delivery and deployment of this device was considered successful.One device was deployed.A completion angiogram was performed during the staged procedure.Imaging with contrast was completed on 15nov2023 (69 days prior to the custom made device (cmd) procedure).The innominate artery, right common carotid artery, right subclavian artery, left common carotid artery, left subclavian artery, and celiac arteries were all incorporated in the repair.They were all patent and no stenosis greater than 50% was identified in the arteries.The diameter of the aorta at celiac wall measured 39 mm.The diameter of the celiac at the intended fixation site was 4 mm.The superior mesenteric artery was incorporated in the repair and was patent.No stenosis greater than 50 % was identified.The diameter of the aorta at superior mesenteric artery was 35 mm.The distance from the celiac artery to the middle of the superior mesenteric artery measured 28 mm.The diameter of superior mesenteric artery at the intended fixation site measured 7 mm.The right renal artery was incorporated in the repair and was patent.No stenosis greater than 50 % was identified.The diameter of the aorta at the right renal artery measured 30 mm.The distance from the celiac to the middle of the right renal artery was 58 mm.The diameter of right renal artery at the intended fixation site was 6 mm.The left renal artery was incorporated in the repair and was patent.No stenosis greater than 50 % was identified.The diameter of the aorta at the left renal artery measured 34 mm.The distance from the celiac to the middle of the left renal artery was 62 mm.The diameter of left renal artery at the intended fixation site was 7 mm.The right common iliac artery was patent.The diameter at the intended fixation site was 14 mm.The maximum diameter was 16 mm.The length from the celiac to the iliac bifurcation measured 229 mm.The left common iliac artery was patent.The diameter at the intended fixation site was 12 mm.The maximum diameter was 15 mm.The length from the celiac to the iliac bifurcation measured 231 mm.The right and left internal iliac arteries were patent.The aortic valve was native.The method of measurement was centerline.The length from the sinotubular junction, or proximal suture if ascending aorta is replaced by graft, to the celiac artery measured 366 mm.The length from left common carotid artery to celiac artery measured 300 mm.The length from the lowest renal artery to the aortic bifurcation measured 118 mm.The maximum diameter of the diseased aorta on center line measured 57 mm.The intended proximal landing was zone 5: mid descending aorta to celiac.The shape of the proximal seal zone was described as parallel.The largest diameter of the proximal neck measured 36 mm.The length of the proximal neck measured 99 mm.The intended distal landing zone was zone 10: common iliac arteries on the left and right.A second staged procedure was completed on (b)(6) 2023 under local anesthesia.An intercostal and lumbar artery embolization was performed.No arterial stents were deployed during the procedure.The pre-procedure clinical assessment was completed one day prior to the custom made device (cmd) study procedure on (b)(6) 2024.The primary indication for the procedure was an aortic degenerative aneurysm, a thoracic abdominal aortic aneurysm (taaa).The aneurysm was classified as an extent iv (abdominal aneurysm extending up to the celiac axis).There was history of the aneurysm growth being greater than or equal to 1.0 cm/year.The procedure was considered "elective".The patient underwent general anesthesia for the cmd study procedure on (b)(6) 2024.A the time of the procedure the patient's antiplatelet therapy was aspirin (acetylsalicylic acid).Percutaneous access was obtained in the right and left femoral arteries.An iliac conduit was not performed at the time of the cmd procedure.The total contrast volume used during the procedure was 225 ml.The contrast dose was 300 ml/kg.Fluoroscopy time was 64 minutes.The total gray used was 1442 mgy.The total dose area product was 12 mgy*cm2.Fusion was used during the procedure.The estimated blood loss during the operation was 300 ml.Cardiac output reduction was not used.The proximal seal zone: endograft.Neuromonitoring near-infrared spectroscopy (nirs)was used during the procedure.Procedural time (24 hour clock): time arrives in room 08:45 time of first incision or arterial puncture 09:15 time of last access closure 13:00 time leaves room 13:18 duration of procedure (from first incision to last access closure) 225 minutes a competitor's stent (8 mm x 57 mm) and was placed in the celiac artery.The artery was revascularized with the fenestrated branch device.The covered stent was not relined and was not extended distally with a bare metal stent.The side branch catheterization and placement of the bridging stent was considered a technical success.The stent patency was maintained with normal end artery perfusion.Competitor's stents (8 mm x 57 mm) and (10 mm x 37 mm) were placed in the superior mesenteric artery (sma).The artery was revascularized with the fenestrated branch device.The covered stent was not relined and was not extended distally with a bare metal stent.The side branch catheterization and placement of the bridging stent was considered a technical success.The stent patency was maintained with normal end artery perfusion.Competitor's stents (7 mm x 50 mm) and (7 mm x 37 mm) were placed in the right renal artery.The artery was revascularized with the fenestrated branch device.The covered stent was not relined and was not extended distally with a bare metal stent.The side branch catheterization and placement of the bridging stent was considered a technical success.The stent patency was maintained with normal end artery perfusion.Competitor's stents (6 mm x 50 mm) and (6 mm x 38 mm) were placed in the left renal artery.The artery was revascularized with the fenestrated branch device.The covered stent was not relined and was not extended distally with a bare metal stent.The side branch catheterization and placement of the bridging stent was considered a technical success.The stent patency was maintained with normal end artery perfusion.The side branch catheterization and placement of all bridging stents was considered technically successful.A cook custom made device (rpn: thoraco-abdominal-side-branch) was implanted during the procedure.The cmd was planned for this patient.The length of the main aortic device was 218 mm.There were no technical difficulties in the delivery and deployment of the main cmd device.The delivery and deployment of the main cmd device was considered successful.A distal aortic custom made device (cmd) that was planned for this patient (rpn: aaa-bifurcated-graft, lot number ac1145907) was implanted in the patient.The proximal size of the aortic device was 22 mm.There were no technical difficulties in the delivery and deployment of this device.The delivery and deployment of this device was considered successful.A cook zenith spiral-z aaa iliac leg graft (rpn: zsle-16-56-zt, lot number 14117170) was implanted on the patient's right.The distal dimeter of the seal stent was 16 mm and the length was 56 mm.There were no technical difficulties in the delivery and deployment of this device.The delivery and deployment of this device was considered successful.A cook lunderquist extra-stiff double curved exchange support wire guide (rpn: tsmg-35-300-lesdc) was used for in the ipsilateral access site and the target anatomy was the ascending aorta.The device successfully accessed the target vasculature and performed as intended.There were no deficiencies involving the cook ancillary device.A cook lunderquist extra-stiff curved exchange support wire guide (rpn:tsmg-35-260-les) was used for in the ipsilateral access site and the target anatomy was the ascending aorta.The device successfully accessed the target vasculature and performed as intended.There were no deficiencies involving the cook ancillary device.A cook coda balloon (rpn: coda-2-10.0-35-140-46) was used in the proximal sealing zone.The device successfully accessed the target vasculature and performed as intended.There were no deficiencies involving the cook ancillary device.A cook beacon tip 5.0 fr angiographic catheter (rpn: hnbr5.0-35-125-p-ns-vanschie3) was used in the ipsilateral access site to access a branch vessel (renal artery).The device successfully accessed the target vasculature and performed as intended.There were no deficiencies involving the cook ancillary device.A cook amplatz support wire guide (rpn: thsf-35-260) was used in the ipsilateral access site to access a branch vessel (celiac artery).The device successfully accessed the target vasculature and performed as intended.There were no deficiencies involving the cook ancillary device.A cook safe-t-j rosen catheter exchange wire guide (rpn: thscf-35-260-3) was used in the ipsilateral access site to access a branch vessel (renal artery).The device successfully accessed the target vasculature and performed as intended.There were no deficiencies involving the cook ancillary device.A cook flexor raabe guiding sheath (rpn: kcfw-7.0-38-90-rb-raabe) was used in the procedure for delivery of a bridging stent.The device successfully accessed the target vasculature and performed as intended.There were no deficiencies involving the cook ancillary device.A cook safe-t-j rosen catheter exchange wire guide (rpn: thscf-35-260-1.5-rosen) was used in the ipsilateral access site to access a branch vessel (renal artery).The device successfully accessed the target vasculature and performed as intended.There were no deficiencies involving the cook ancillary device.A cook endovascular dilator set (rpn: jcds-1618-eds-hc) was used in the iliac artery for access artery diameter dilation.The device successfully accessed the target vasculature and performed as intended.There were no deficiencies involving the cook ancillary device.During the procedure the patient experienced a splenic artery rupture after cannulation of the target vessel during the deployment of a bridging stent.The site indicated the event was causal related to the study procedure (after deployment of bridging stent) and was possibly related to the use of a cook rosen guide wire during catheterization of the vessel.An endovascular treatment was completed with balloon angioplasty, coil embolization, and deployment of a competitor's stent (6 mm x 50 mm).The patient recovered/stabilized without sequelae and the event was considered resolved by the end of the procedure.Procedural imaging in the form of an angiogram was completed on 23jan2024.All stent grafts and intended side branch stents were patent at the conclusion of the procedure.All target vessels were patent.An angiogram was used to confirm no endoleaks were present at the conclusion of the procedure.There was no evidence of stent graft integrity issues, this was confirmed with an angiogram as well.All target side branch stents were intact.The overlap of stents between the distal device and the arch device was 1-1.9 stents.There was overlap between the distal device and arch graft bridged with an additional tevar device.There was 1-1.9 stents overlap between the distal device and the additional distal device.The overlap between the distal device and additional distal device was bridged with an additional evar device.The patient was extubated in the operating room and did not require reintubation or a tracheostomy.The patient did not stay overnight in the intensive care unit.Follow up computed tomography (ct) with contrast imaging was completed three days post procedure on (b)(6) 2024.All stent grafts were patent.No stenosis or occlusion greater than 50% was noted in the celiac, sma, right renal, or left renal arteries.There was no evidence of stent graft integrity issues.All intended side branch stents were intact.A type 1b distal endoleak was present on the most distal iliac component on the left.The patient was prescribed acetylsalicylic acid, clopidogrel, and a statin at discharge.No anticoagulant was prescribed.The patient was discharged home on (b)(6) 2024.On (b)(6) 2024, a post procedural clinical assessment was completed (7 days post procedure), the patient's current medications were aspirin or asa, an antiplatelet, and a statin.Since the last visit no significant medical problems were experienced by the patient and the patient had not been hospitalized.Follow up imaging in the form of a computed tomography (ct) scan was completed prior to the clinical assessment (26jan2024).The site indicated that a planned staged procedure will follow to address the endoleak.The patient will be followed in the study follow up program.The subject of this report is the type 1b endoleak on the zenith flex with spiral-z technology aaa endovascular graft iliac leg that was identified in the imaging on 26jan2024 (3 days post procedure).A planned staged endoleak will be performed to address the endoleak.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The report of a type 1b endoleak on a zenith flex with spiral-z technology aaa endovascular graft iliac leg is not confirmed in the imaging provided for the investigation.The location where the endoleak was identified does not correlate with the location of a cook incorporated manufactured device.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 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 or that a death or serious injury occurred; nor is it admission 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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