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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
Obstruction of Flow (2423); Malposition of Device (2616)
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| Patient Problems
Cardiac Arrest (1762); Cardiomyopathy (1764); Myocardial Infarction (1969); Renal Failure (2041); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
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| Event Date 08/02/2021 |
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Event Type
Death
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Manufacturer Narrative
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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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Event Description
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On (b)(6) g2021, a patient underwent abdominal aortic aneurysm (aaa) endovascular aortic repair (evar) surgery.During the procedure, the physician inserted the unknown cook graft into the patient's femoral artery and deployed the graft in the abdominal aorta.It is alleged that during the procedure, the surgical/fluoroscopy bed supporting the patient was moved about three-fourths of an inch (3/4") longitudinally.This movement in the surgical/fluoroscopy bed occurred after the anticipated position for graft deployment was "marked" on the operating room monitors but before the graft was deployed.It is alleged that the movement resulted in the physician deploying the cook graft higher in the abdominal aorta than intended.This resulted in blocked circulation to the patient's renal arteries and superior mesenteric artery (sma).A complete angiogram was performed twenty (20) minutes after deployment of the cook graft, revealing the blocked circulation to the renal and mesenteric arteries.The physician then performed an open laparotomy in an attempt to repair the patient's blocked arteries.After the laparotomy surgery, it is alleged the patient developed clotting that blocked vascular circulation.On (b)(6) 2021, the patient underwent an axillobifemoral bypass graft surgery.The patient went into cardiac arrest during the axillobifemoral bypass graft surgery and was pronounced dead at 5:41 p.M.On 11aug2021.The listed cause of death was myocardial infarction and non-ischemic cardiomyopathy.It was reported that the cook sales representative was present for the procedure.
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Manufacturer Narrative
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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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Event Description
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Additional information was provided on 05dec2023.A complete medical record was provided for review, this report contains specifics related to the procedure and subsequent events concerning the cook graft.Procedure date: (b)(6) 2021.The patient was seen in the holding room.The risks, benefits, complications, treatment options, and expected outcomes were discussed with the patient.The possibilities of reaction to medication, pulmonary aspiration, perforation of viscus, bleeding, recurrent infection, the need for additional procedures, failure to diagnose a condition, and creating a complication requiring transfusion or operation were discussed with the patient.The patient concurred with the proposed plan, giving informed consent.The site of surgery properly noted/marked.The patient was taken to the operating room, identified and the procedure verified as aaa repair.A time out was held and the above information confirmed.General endotracheal anesthesia was initiated after placement of appropriate monitoring lines.An arterial line was placed.Arms were tucked at the sides.All pressure points were well padded.Intravenous antibiotics were confirmed.The patient was prepared and draped in the usual sterile fashion.Incision was made at 10:19 am.A transverse incision was made in the right groin.Dissection was carried down to the common femoral artery.The common femoral artery had moderate atherosclerotic disease and a reasonable pulse.There were several enlarged lymph nodes in the right groin.These were removed, and sent for pathologic review.A transverse incision was made in the left groin.Dissection was carried down to the common femoral artery.The common femoral artery had mild significant disease and a reasonable pulse.Heparin was administered intravenously.The activated clotting time rose to >250 seconds.Activated clotting times were obtained every 30 minutes.These were maintained above 200 seconds.A thin-walled 18-gauge needle was inserted into the left common femoral artery.A 9 french short sheath was inserted into the left common femoral artery.The 0.035 j-wire passed into the juxta renal aorta without difficulty.A competitors catheter was positioned in the juxta renal aorta.The super stiff wire guide was advanced into the competitor's catheter.The competitor's catheter was removed.A thin-walled 18-gauge needle was inserted into right common femoral artery.A j-wire was then advanced.A 6 french sheath was inserted into the right common femoral artery.A competitor's marking catheter was passed through the right common femoral sheath, and placed at the middle of l2 vertebral body.At no point during the operation did wires reach the aortic arch.The wires were all kept within the proximal descending thoracic aorta.An angiogram was obtained which demonstrated the location of the renal arteries.The left renal artery was slightly lower.The main body was prepared per manufacturer's instructions.The main body was then placed through the left common femoral artery.It was positioned near the left lowest renal artery.With the stent placed, an additional angiogram was performed at high magnification (6 cm}.The main body was unsheathed at the lowest renal artery.The main body was deployed to the contralateral gate.It should be noted at this point that the medical device representative marked both the operating room monitor as well as the auxiliary monitor.The mark on the operating room monitor had no parallax.After pulling the competitor's marking catheter back to the right lilac artery, the graft was deployed immediately at this mark.Both the operating room monitor and the auxiliary monitors correlated with deployment at this mark.The contralateral gate was cannulated with the competitor's marking catheter and a j wire.Confirmation of cannulation was performed by free rotation of the competitor's marking catheter near the renal arteries.A second competitor's marking catheter was placed in the right common femoral sheath.A super stiff guide wire was placed through the competitor's marking catheter.A retrograde angiogram was performed in lao (left anterior oblique) caudal.This demonstrated 130 mm to the common lilac bifurcation.A cook 13-107 iliac limb was obtained, and prepared.This was advanced through the right femoral sheath and deployed with one stent overlap.The main body stent was fully deployed.A competitor's marking catheter was placed in the left common femoral sheath.A retrograde angiogram was performed in rao (right anterior oblique) caudal.This demonstrated 70 mm to the common iliac bifurcation.A cook 13-90 iliac limb was obtained, and prepared.This was advanced through the left femoral sheath with one stent overlap.The cook coda balloon was advanced through the right femoral sheath over the wire guide.The coda was used to balloon the right iliac limbs and connections as well as the infrarenal landing zone.The cook coda balloon was advanced through the left femoral sheath, and balloon angioplasties were completed in the left iliac limb, connections, and the infrarenal landing zone.A completion angiogram demonstrated the graft was displaced proximally.It appeared the covered stent covered the origin of both renal arteries and the superior mesenteric artery.The patient was still fully anticoagulated, and the renal arteries were receiving some antegrade flow.The situation was discussed with the operating room personnel.Open repair versus endovascular repair was discussed.It appeared endovascular repair would be difficult and may limit repair of the abdominal aortic aneurysm.If endovascular repair was not feasible, a longer delay to revascularization would be present.As such, the operating room personnel felt it prudent to proceed with open repair.A primary laparotomy incision was made.There were no adhesions in the abdomen.The transverse colon and omentum were eviscerated cephalad.The small bowel was eviscerated to the right lateral.There was a large abdominal aorta present.The retroperitoneum was opened.The duodenum was mobilized away from the aneurysm and retroperitoneum.The retroperitoneum was opened from the renal arteries to the bifurcation.A supra celiac aortic clamp was performed at 11:20 am.The aneurysm was opened.All thrombus was removed.The main body was separated from the iliac limbs.The main body was cut longitudinally across the struts.In this fashion, it released the radial force.The main body was cut on both the anterior and posterior sections of the graft.The graft was initially pushed posteriorly, and further cutting with heavy scissors divided the anterior struts up to the supra renal fixation.The graft was pulled anteriorly, and further cutting with the heavy scissors divided the posterior struts up to the supra renal fixation.The main body was removed.During the above, the patient had hypotension and bradycardia.Cpr was initiated at 11:54 am.Epinephrine boluses were administered and rapid transfusion initiated.The rhythm stabilized and the pressure rose.The abdominal aorta was clamped supra renal.The supra celiac aortic clamp was removed at 12:42 pm.The previous events as well as concern for bowel and kidney ischemia were discussed with the patient's wife and son.A 24-12 graft (manufacturer unknown) was obtained and the main body was cut short.We initially attempted to sewn the graft to the abdominal aorta with a running 3-0 non-absorbable suture.However, the abdominal aorta was quite friable, and sutures pulled free in the posterior region.It did not appear this was a suitable solution to sew further to the abdominal aorta.Further inspection revealed friable aortic wall.A clamp was passed around the abdominal aorta above the renal arteries but below the superior mesenteric artery.An umbllical tape was passed around the abdominal aorta, and the aorta tied occluded.There was some antegrade bleeding.Another umbilical tape was passed, and on securing this umbilical tape the aorta was nearly occlusive.The stump was over sewn with 3-0 non-absorbable suture.There were several patent lumbars.These were over sewn with non-absorbable sutures.Both iliac limbs were closed with umbilical tape.At this point, the aorta appeared hemostatic.The retroperitoneum was hemostatic.The abdominal aortic aneurysm sac was closed with a running 4-0 non-absorbable suture.The retroperitoneum was then closed with a running 4-0 non-absorbable suture.The small bowel was returned to its normal location.The small bowel appeared to be pink.The small bowel produced peristalsis with finger pinching.The transverse colon was returned to its normal location.The laparotomy was closed with a running double stranded #1 synthetic absorbable suture.The midline incision was irrigated with normal saline.The skin was closed with surgical staples.Another debriefing was completed with the operating room staff.It was discussed that the bleeding was controlled, but there was little flow to the legs at this point.The need for an axlllo bifemoral graft was discussed.The deployment of the endovascular stent graft was also discussed.The imaging for the case was reviewed at this point.An initial image had been obtained prior to obtaining the endovascular stent graft.The endovascular stent graft had been prepared, and inserted into the aorta.Another image had been obtained under high magnification due to the shorter infra renal neck.During this debriefing, operating room staff recalled this image.The graft was slightly high, and all recalled the graft being withdrawn to the above mentioned lines on both the operating room monitor and the auxiliary monitor.The graft was unsheathed to the contralateral gate.The magnification had been decreased to visualize the contra lateral gate, and then restored to its high magnification.Two possible causes of the high deployment were discussed, including either stored tension in the deployment system or the bed moving.Operating room staff remembered all bed locks were in place.The surgeon recalled that he had released pressure on the sheath multiple times to ensure no stored tension in the deployment system, and other concurred seeing this.The right arm was removed from the draped.At this point, the patient was prepped for an axillo bifemoral bypass.While the operating room was preparing for the above, the events were discussed with the patient's wife , two sons, and daughter in law.During the above, anesthesia placed a central line in the internal jugular vein.An oblique incision was made in the right infra clavicular space.This was angled at 45 degrees from the mid clavicular region to the lateral edge of the pectoralis muscle.The pectoralis major muscle fibers were separated along tissue planes.The pectoralis minor was divided.The axillary artery was identified.This was rather pliable with minimal palpable plague.There was a strong pulse.A tunnel was created between the axillary and right groin incisions.Proximal and distal control of the axillary artery was accomplished.An 6 mm dacron graft was obtained, and a longitudinal arteriotomy was created in the axillary artery.The graft was sewn end to side with a running 6-0 non-absorbable suture.The graft was de aired.Perfusion was restored to the right arm.Hemostasis was ensured at all surgical sites.Proximal and distal control of the right femoral artery was accomplished.A longitudinal arteriotomy was created.There was a large posterior plaque.An endarterectomy was performed.The graft was cut to length, and the end spatulated.The graft was sewn end to side with a running 6-0 non-absorbable suture.Perfusion was first restored to the lilacs.Perfusion was then restored to the profunda.Perfusion was restored to the superficial femoral artery last.Another incision was made overlying the graft in the right lower quadrant.A separate graft was tunneled between this incision and the left groin.The graft was spatulated.Proximal and distal control of the axillo-right femoral graft was obtained.A longitudinal arteriotomy was created.The graft was sewn side to side with a running 6-0 non-absorbable suture.This created a "lazy s" configuration of the anastomosis.The graft was de aired, and flow restored to the right lower extremity.Proximal and distal control of the left femoral artery was accomplished.A longitudinal arteriotomy was created.The graft was cut to length, and the end spatulated.The graft was sewn end to side with a running 6-0 non-absorbable suture.Perfusion was first restored to the iliacs.Perfusion was then restored to the profunda.Perfusion was restored to the superficial femoral artery last.Protamine was administered.Hemostasis was ensured at all surgical sites.Vancomycin powder was placed at all exposed portions of the graft.The groins were closed in three layers with running synthetic absorbable 2-0 suture.The groin incisions were then closed at the skin level with a running subcuticular horizontal mattress 3-0 synthetic absorbable suture.The subclavicular incision was closed with two layers of running synthetic absorbable 2-0 sutures, and the skin was closed with a running subcuticular horizontal mattress 3-0 synthetic absorbable suture.Another debriefing was performed during this time period.While the above was being performed, the device representative and the radiology technician had reviewed all imaging in the control room.They particularly noted the vertebral bodies during the angiograms, and subsequent imaging.They determined that at a time between the high magnification angiogram and the next subsequent imaging, the bed had been moved in a longitudinal orientation, from head towards the feet.This movement was not recognized at the time by any operating staff.This was only noted on detailed review by the device representative and radiology technician.Sterile dressings were placed.At the end of the operation, all sponge, instruments, and needle counts were correct.A debriefing was had with the device representative.The imaging was reviewed by the surgeon and device representative.The device representative again stated the best explanation for the device being deployed higher than expected was longitudinal movement of the fluoroscopy bed in a head to toe orientation.This movement would have only been about 15 mm or 3/4 inch.At this time, the device representative also notes that it is his standard practice to place a line on both the operating room monitor and the auxiliary monitor from aortic wall to aortic wall.After the main body stent was deployed, he recalled that the line on his auxiliary monitor did not reach aortic wall to aortic wall.This confirmed that the bed had moved from the time point of the high magnification angiogram and deployment of the main body.The aorta was wider just above the renal arteries than at the location of the renal arteries.The time mark between the high magnification angiogram (10:31 am) to the next imaging where the competitors marking catheter was in the right iliac artery {10:34 am) was only three minutes.The bed had moved in a longitudinal direction only, and not in a transverse projection.The completion angiogram was time mark at 10:54 am, noting approximately 20 minutes of partial occlusion renal / sma since recognition.There was strong doppler signals in the left pt and dp.The left foot was pink.However, the right leg was pale and no doppler signals could be obtained.The patient was prepped with circumferential prep of the right leg.A longitudinal incision was made in the right groin.Dissection was carried down to the common femoral graft.Additional heparin was administered.The graft was removed from the common femoral artery after proximal and distal control.There was fresh thrombus in the common femoral artery.The graft had good in flow.Thrombus was removed from the superficial and profunda femoral arteries.There was some back bleeding from both.It appeared there was an intimal flap.All loose debris was removed from the lumen of the common femoral artery.A patch angioplasty was performed with a vascular repair patch.The intima of the superficial femoral artery was reinforced with interrupted 7-0 non-absorbable suture.A vascular repair patch (photo fix) was sewn with a running 6-0 non-absorbable suture.Back bleeding was performed in all vessels.The graft was fully de aired.The patch was completed a longitudinal incision was made in the patch angioplasty.The right limb of the axllio bifemoral graft was sewn end to side with a running 6-0 non-absorbable suture.Perfusion was first restored to the iliacs.Perfusion was then restored to the profunda.Perfusion was restored to the superficial femoral artery last.There was strong doppler signals in the superficial and profunda femoral arteries.There were strong doppler signals in the right pt and dp.The right foot began to appear pink.Protamine was administered.Hemostasis was assured at all surgical sites.The deep fascia were closed with running synthetic absorbable suture.The wounds were irrigated with normal saline.Two additional layers of running absorbable suture were then utilized.Counts were correct.Sterile dressings were placed.The patient had doppler signals in both feet.Both feet were well perfused without evidence of emboli.Completion chest x-ray (cxr) and kidneys, ureter, and bladder x-ray (kub) were obtained.This demonstrated acceptable location of endotracheal tube (ett), central line, and nasogastric tube (ng).However, there was a portion of the competitor's marking catheter retained within the body.It is presumed the competitor's marking catheter was transected when the main body was transected, was then pushed cephalad during the attempt to remove the main body.The catheter was never seen within the operative field.Another debriefing was performed with the operating room staff.No additional details were remembered at the time.No additional information was obtained with the discussion.Fluoroscopy time was 11.4 minutes and 110 ml of contrast was used.Cell saver was employed intraoperatively and volume of 2447ml was recorded.Total operative time was 7 hours and 8 minutes.Patient left the operating room at 6:37 pm and was discharged to the intensive care unit (icu).The patient was intubated and hemodynamically stable.On (b)(6) 2021, the patient had a dialysis catheter inserted into the left internal jugular vein.The patient tolerated the procedure well.The patient was extubated on (b)(6) 2021.On (b)(6) 2021 the patient had progressive thrombocytopenia, fever, and leukocytosis.Cultures were drawn and broad spectrum antibiotics initiated.Heparin exposure was removed, and a heparin induced thrombocytopenia (hit) panel obtained.Hematology was consulted.Hit panel resulted positive.Hematology recommended starting argatroban and the infusion was initiated.On (b)(6) 2021 the patient had a 5 french triple lumen peripherally inserted central catheter (picc) line inserted due to multiple medications being administered simultaneously.The dialysis catheter was removed after the picc line was placed.The patient tolerated the procedure well.During the morning of (b)(6) 2021, the patient lost pulses in the legs.Patient was conversant, and stated both legs were numb from the waist down.He had no motor function.The axillo bifemoral bypass graft was confirmed occluded by ultrasound.Patient underwent a reintervention procedure on (b)(6) 2021 where a successful thrombectomy of the occluded axillo bifemoral bypass graft was completed.Bilateral lower extremity angiograms were completed.During the procedure the patient became hemodynamically unstable.Bradycardia developed and degenerated to ventricular fibrillation.Cardioversion was performed and chest compressions were initiated.A temporary transcutaneous pacing was performed and a rhythm was obtained.However, the patient developed ventricular fibrillation and hypotension.A cardioversion was performed again along with chest compression.A temporary pacing wire was placed by the hospital electrophysiologist who was summoned to the operating room.After insertion of the pacemaker, there appeared to be no significant cardiac output.Despite successful revascularization of both lower extremities, the patient developed cardiac arrest from either myocardial dysfunction or myocardial ischemia.Resuscitation was unsuccessful.The patient expired at 5:41 pm.The provided death certificate lists immediate cause of death as myocardial infarction and non ischemic cardiomyopathy.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: d4: (lot number, unique identifier (udi), expiration date), d10 (concomitant products), h4 (manufacture date).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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Event Description
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No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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Investigation-evaluation: cook was notified of an event where a zenith flex aaa endovascular graft bifurcated main body (tffb-24-96-zt) was implanted above bilateral renal artery ostia, resulting in renal failure.The patient underwent an endovascular aortic repair on (b)(6) 2021.A cook zenith flex aaa endovascular graft bifurcated main body (tffb-24-96-zt) was implanted during the procedure.It was alleged that during the procedure, the surgical/fluoroscopy bed supporting the patient was moved about three-fourths of an inch (3/4") longitudinally.The movement of the bed was alleged to have occurred between the time the anticipated position for graft deployment was "marked" on the operating room monitors and the time that the graft was deployed.As a result, the physician deployed the graft higher up in the abdominal aorta than intended, blocking circulation to the patient's renal arteries and superior mesenteric artery.This was confirmed by a complete angiogram that was performed twenty (20) minutes after deployment of the cook graft.The physician then performed an open laparotomy in an attempt to repair the patient's blocked arteries.During the open surgical repair, the cook zenith flex aaa endovascular graft bifurcated main body (tffb-24-96-zt) was removed.During the removal process, the patient developed hypotension and bradycardia.Cardiopulmonary resuscitation (cpr) was initiated, epinephrine boluses were administered, and a rapid blood transfusion was initiated.The patient¿s rhythm stabilized, and the pressure rose.Another manufacturer¿s graft was placed in the aorta, and it was discovered that the abdominal aorta was ¿friable.¿ actions were taken until the aorta appeared hemostatic.The laparotomy was then closed.Bleeding was controlled but there was little flow to the legs.The patient required an axillobifemoral bypass procedure where a graft from another manufacturer (dacron) was placed.An endarterectomy was performed and an arteriotomy was created to restore flow to the legs.The patient was transferred to the intensive care unit.On (b)(6) 2021 the patient had progressive thrombocytopenia, fever, and leukocytosis.Cultures were drawn and broad-spectrum antibiotics were initiated.Heparin exposure was removed.Heparin-induced thrombocytopenia (hit) was confirmed.An anticoagulant infusion was initiated.During the morning of (b)(6) 2021, the patient lost pulses in the legs.The patient was conversant and stated both legs were numb from the waist down.The patient had no motor function.Occlusion of the axillo bifemoral bypass graft was confirmed occluded by ultrasound.The patient underwent a reintervention procedure on (b)(6) 2021 where a thrombectomy of the occluded axillo bifemoral bypass graft was completed successfully.However, during the procedure, the patient became hemodynamically unstable.Bradycardia developed and degenerated to ventricular fibrillation.Cardioversion was performed and chest compressions were initiated.A temporary transcutaneous pacing was performed, and a rhythm was obtained.However, the patient developed ventricular fibrillation and hypotension.A cardioversion was performed again along with chest compressions.A temporary pacing wire was placed by the hospital electrophysiologist who was summoned to the operating room.However, after the insertion of the pacemaker, there appeared to be no significant cardiac output.Despite successful revascularization of both lower extremities, the patient developed cardiac arrest from either myocardial dysfunction or myocardial ischemia.Resuscitation was unsuccessful.The patient expired at 5:41 pm with the immediate cause of death to be myocardial infarction and non-ischemic cardiomyopathy.Reviews of the complaint history, device history record (dhr), drawing, instructions for use (ifu), and quality control were completed 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.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A complaint history search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting a nonconforming product exists either in-house or in the field.Cook also reviewed product labeling.The ifu supplied with the device states the following in consideration of the reported failure mode: ¿2 indications for use the zenith flex aaa endovascular graft with the z-trak introduction system is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair, including: ¿ adequate iliac/femoral access compatible with the required introduction systems, ¿ 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.¿ iliac artery distal fixation site greater than 10 mm in length and 7.5-20 mm in diameter (measured outer wall to outer wall).4 warnings and precautions 4.1 general ¿ read all instructions carefully.Failure to properly follow the instructions, warnings and precautions may lead to serious consequences or injury to the patient.¿ always have a qualified surgery team available during implantation or reintervention procedures in the event that conversion to open surgical repair is necessary.4.5 implant procedure ¿ appropriate procedural imaging is required to successfully position the zenith flex aaa endovascular graft and assure accurate apposition to the aortic wall.¿ inadvertent partial deployment or migration of the endoprosthesis may require surgical removal.¿ unless medically indicated, do not deploy the zenith flex aaa endovascular graft in a location that will occlude arteries necessary to supply blood flow to organs or extremities.Do not cover significant renal or mesenteric arteries (exception is the inferior mesenteric artery) with the endoprosthesis.Vessel occlusion may occur.During the clinical study, this device was not studied in patients with two occluded internal iliac arteries.¿ do not attempt to re-sheath the graft after partial or complete deployment.¿ repositioning the stent graft distally after partial deployment of the covered proximal stent may result in damage to the stent graft and/or vessel injury.¿ 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.¿ 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.¿ avoid damaging the graft or disturbing graft positioning after placement in the event reinstrumentation (secondary intervention) of the graft is necessary.5 adverse events 5.2 potential adverse events adverse events that may occur and/or require intervention include, but are not limited to: ¿ death ¿ embolization (micro and macro) with transient or permanent ischemia or infarction ¿ 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 ¿ graft or native vessel occlusion ¿ renal complications and subsequent attendant problems (e.G., artery occlusion, contrast toxicity, insufficiency, failure) 10 clinical use information 10.1 physician training caution: the zenith flex aaa endovascular graft with the z-trak introduction system should only be used by physicians and teams trained in vascular interventional techniques and in the use of this device.The recommended skill/knowledge requirements for physicians using the zenith flex aaa endovascular graft with the z-trak introduction system are outlined below: a multidisciplinary team that has combined procedural experience with: ¿ fluoroscopic and angiographic image interpretation ¿ embolization ¿ angioplasty ¿ endovascular stent placement ¿ appropriate use of radiographic contrast material 11 directions for use pre-implant determinants verify from pre-implant planning that the correct device has been selected.Determinants include:¿ 5.Distance from renal arteries to the aortic bifurcation.Patient preparation 11.1.4 vascular access and angiography¿ 2.Perform angiography to identify level(s) or renals, aortic bifurcation and iliac bifurcations.11.1.5 main body placement¿ 4.Before insertion, position main body delivery system on patient¿s abdomen under fluoroscopy to determine the orientation of the contralateral limb radiopaque marker.The sidearm of the hemostatic valve may serve as an external reference to the contralateral limb radiopaque marker.5.Insert main body delivery system over the wire, into the femoral artery with attention to sidearm reference.6.Advance delivery system until the four gold radiopaque markers (which are positioned 2 mm from the most proximal segment of the graft material) (fig.9, illustration 1) are just inferior to the most inferior renal orifice.7.Verify position of wire guide in the thoracic aorta.Ensure the graft system is oriented such that the contralateral limb is positioned above and anterior to the origin of the contralateral iliac.If the contralateral limb radiopaque marker is not properly aligned, rotate the entire system until it is correctly positioned halfway between a lateral and an anterior position on the contralateral side.Note: radiopaque cannula on each stent between the renal arteries and the contralateral limb align with the contralateral limb radiopaque marker.8.Repeat the angiogram to verify the four gold radiopaque markers are 2 mm or more below the most inferior renal orifice.9.Ensure the captor hemostatic valve on the flexor introducer sheath is turned to the open position.(fig.10) 10.Use the gripper to stabilize the gray positioner (the shaft of the delivery system) while withdrawing the sheath.Deploy the first two covered stents by withdrawing the sheath while monitoring device location.(fig.18) 11.Without moving the table, decrease magnification to check position of the contralateral limb radiopaque marker and location of renal arteries.Proceed with deployment until the contralateral limb is fully deployed.(fig.11) stop withdrawing sheath.11.1.17 main body proximal (top) deployment 1.Perform angiography through an angiographic catheter to verify position of the endovascular graft with respect to the renal arteries.If necessary, carefully reposition the covered portion of the endovascular graft with respect to the renal arteries.(repositioning can only take place over a small range of distance at this stage.) note: ensure patency of renal arteries by confirming that the proximal graft markers are 2 mm or more below the lowest patent renal artery.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.¿ intraoperative angiography from the event was provided for the investigation.A review of the imaging was completed by an expert image reviewer.The reviewer¿s impression ¿1.Sealing stent implantation over the sma and ras is confirmed.2.Table movement relative to the screen marks cannot be confirmed as an image of the marked screen was not provided.3.The vertebral body position relative to the ras provided a general reference point for the patient¿s position relative to the marked screen.Additionally, in this case, the exact location of the right ra was knowable by the right ra calcification.Hence, the table movement would have been recognizable before and during unsheathing.4.After unsheathing and before suprarenal stent release, differential expansion of the sealing stent compared to the second mainbody stent would have made sealing stent¿s position over the ras recognizable and possibly remediable.¿ based on the available information, no product return, and the results of the investigation, a definitive root cause for this event could not be established.Based on the available information, cook has concluded that a potential cause of the malposition of the device and coverage of bilateral renal arteries could be traced to unintentional use error.The operative notes report a suspected 15 mm movement of the operating table during the procedure that was undetected until after complete stent deployment.Imaging review further identified multiple markers¿including vertebral body position in relation to the graft, right renal artery calcification, and, after unsheathing but before suprarenal stent release, differential expansion of the sealing stent compared to the second main body stent.These markers would have aided the clinician in locating the renal arteries before and during the deployment of the graft, before using contrast.There is no evidence of any design or manufacturing-related cause for the malposition of the device.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 death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to death or serious injury if a malfunction occurred.
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Event Description
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No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
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Search Alerts/Recalls
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