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It was reported through the clinical study (b)(6) study "on (b)(6) 2022 the patient was treated for a saccular bifurcation aneurysm, located on the right middle cerebral artery (mca).The aneurysm never ruptured and was not previously treated.Embolization treatment consisted of using a stent lvis evo and embolization coils.On (b)(6) 2022 the patient was discharged.On (b)(6) 2022 the patient had an ischemic stroke, measure taken was an endovascular treatment by mechanical thrombectomy.The outcome is death on (b)(6) 2022.Association with lvis evo or the embolization coils or the relationship to study devices, ancillary devices, index endovascular procedure or study or concurrent disease condition was still not completed." additional information indicated that on " (b)(6) 2022 (discharge): the neurological evaluation of the patient is mrs score 1, nihss score 0." "(b)(6) 2022 (5 days post-procedure): the patient is symptomatic.The event was not associated with lvis evo or hydrocoils malfunction.The event is unlikely to be related to lvis evo device and probably related to concurrent disease (covid infection).The outcome is death on (b)(6) 2022." additional information from medical report: right ischemic cerebral stroke in context of in-stent occlusion of the right cerebral artery recently placed for an evolving cerebral aneurysm.Failure of thrombectomy and iatrogenic dissection of the artery.Unfavorable evolution toward cerebral involvement then encephalic death.
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Visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Based on a review of the device's risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: a search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.Complaint system review: there are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.Ifu review (additional information can be found in the ifu, following is taken from the english version): potential complications possible complications include but are not limited to the following: hematoma at the puncture site perforation or dissection of the vessel(s) intravascular spasm hemorrhaging rupture or perforation of aneurysm coil herniation device migration neurologic insufficiencies including stroke and death ischemia vascular occlusion vessel stenosis incomplete aneurysm occlusion pseudoaneurysm formation distal embolization headache infection reaction to contrast agents including severe allergic reactions and renal failure.Directions for use 1.Gain vascular access according to standard practice.2.Place guide catheter in the appropriate target vessel.3.A.Navigate the microcatheter (.017" id microvention headway® 17 microcatheter or scepter c® / scepter xc® occlusion balloon) over a guidewire at least 15 mm distal to the aneurysm neck or target location.B.A second microcatheter can be navigated into the aneurysm sac for future coil deployment steps using the jailing technique (steps 22 - 24).In this technique, the microcatheter is effectively jailed between the vessel wall and outer surface of the stent and the coils are kept within the aneurysm and outside of the reconstructed vessel lumen.4.Remove the guidewire.5.Maintain flush through the microcatheter per standard endovascular practice.6.Select an appropriately sized lvis evo device (refer to table 1).7.Carefully inspect the lvis evo device package for damage to the sterile barrier.8.Peel open the pouch using aseptic technique.9.Carefully place the dispenser coil into the sterile field.10.A.Unclip the molded cap attached to the delivery wire from the dispenser coil.Pull on the proximal end of the delivery wire until the introducer exits the dispenser coil.Hold the delivery wire and introducer together while continuing to remove the entire device.Do not partially deploy the lvis evo device from the introducer.B.After removal from the dispenser coil, carefully push on the delivery wire and in a bowl of saline, partially deploy the lvis evo implant up to 5 mm or 50% (whichever occurs first, being careful not to detach the implant) from the distal introducer tip (refer to table 1 and figure 3).Check for the following: implant distal marker uniformity implant distal end shows even displacement with no entanglement implant tracks smoothly through introducer.Warning: do not fully deploy lvis evo device.C.With the lvis evo implant and introducer sheath positioned and hydrated within the bowl of saline, gently manipulate the lvis evo implant within the saline to hydrate the implant and minimize visible air bubbles.Carefully pull back on the delivery wire to fully retrieve the lvis evo implant and the delivery wire tip within the introducer.Warning: do not continue if any defect is observed; return the unit to microvention, inc.11.Confirm that the tip of the delivery wire is entirely within the introducer.12.Confirm that the delivery wire is not kinked and that the introducer tip is not damaged.Do not continue if either defect is observed; return the unit to microvention, inc.Warning: do not shape the tip of the delivery wire.13.Partially insert the distal end of the introducer into the rhv connected to the microcatheter.Tighten the rhv locking ring.Flush the y-connector of the rhv with sterile saline and verify that fluid exits the proximal end of the introducer.Warning: purge the lvis evo device carefully to avoid the accidental introduction of air into the system.14.Untighten the rhv locking ring and advance the introducer until it is fully engaged with the microcatheter hub, then tighten the rhv locking ring.Warning: confirm that there are no air bubbles trapped anywhere in the system.Caution: the introducer must be properly engaged with the microcatheter hub to enable lvis evo device introduction into the microcatheter.15.Advance the delivery wire to transfer the lvis evo device from within the introducer into the microcatheter.Warning: do not torque the delivery wire while advancing or retracting the lvis evo device.A torque device should not be used.16.Continue advancing the delivery wire into the microcatheter until the proximal tip of the delivery wire enters the introducer.Loosen the rhv locking ring, remove the introducer, and set it aside.Note: fluoroscopy may be used up to this point at the physician's discretion.Warning: do not apply undue force.If resistance is encountered at any point during lvis evo device delivery or manipulation, withdraw the unit and select a new lvis evo device.17.Track the lvis evo device through the microcatheter to the tip.Carefully advance the lvis evo device until the device exit marker on the proximal end of the delivery wire approaches the rhv on the hub of the microcatheter.At this time, fluoroscopic guidance must be initiated.18.Position the lvis evo device for deployment by aligning the lvis evo implant distal radiopaque end markers approximately 7 mm or adequate length past the aneurysm neck.Note: a proper push/pull technique, encompassing sufficient delivery wire push force, in addition to an opposing microcatheter withdrawal force, will facilitate properly deploying the lvis evo device to achieve full expansion and good vessel apposition.Note: slowly advancing the lvis evo device while adjusting the microcatheter position will ensure accurate deployment.Maintain simultaneous control of the lvis evo device and microcatheter in order to position and expand the device at the proper location.Caution: using a rapid microcatheter withdrawal technique to deploy the lvis evo device is not recommended and may result in device elongation.19.If lvis evo device positioning is not satisfactory, the lvis evo device may be recaptured and repositioned if it is not fully deployed.The lvis evo device may be recaptured until the point where the proximal end of the lvis evo device markers is aligned 3 mm proximally with the microcatheter distal marker band.Caution: if resistance is felt while recapturing the lvis evo device, do not continue to recapture the device.Withdraw the microcatheter slightly to unsheath the lvis evo device (without exceeding the recapture limit), and then attempt to recapture the lvis evo device.Caution: the lvis evo device must not be re-deployed more than three times.Note: the lvis evo device delivery wire should not be utilized as a guidewire.Do not torque the lvis evo device.A torque device should not be used.20.If lvis evo device positioning is satisfactory, carefully retract the microcatheter and advance the delivery wire together, to allow the lvis evo device to deploy across the neck of the aneurysm.Ensure the device proximal radiopaque end markers are approximately 7 mm or adequate length proximal to the aneurysm neck to ensure an adequate landing zone.The lvis evo device will expand and total length may foreshorten up to 60% from its undeployed length (refer to table 1) as it exits the microcatheter.Ensure microcatheter is retracted and clear from the proximal flared ends.Note: visualize and refer to the implant radiopaque end markers to maintain adequate implant length, approximately 7 mm or adequate length on each side of the aneurysm neck or target location to ensure appropriate neck coverage.Warning: do not detach the lvis evo device if it is not properly positioned in the parent vessel.Observe the delivery wire distal tip to assure it remains within the desired location of the parent vessel.21.Prior to removing the delivery wire and if necessary, carefully position the microcatheter distal to the lvis evo device to maintain access through the lvis evo device.Remove and discard the delivery wire.Warning: the lvis evo device delivery wire should not be utilized as a guidewire.Do not torque the lvis evo device.A torque device should not be used.22.A.If applicable, advance a.017" inner diameter (or suitable size) microcatheter over the guidewire.B.If a second microcatheter has been placed into the aneurysm in step 3b, detachable coils can be delivered into the aneurysm through the second microcatheter (replacing steps 22-24).Warning: ensure that the jailed microcatheter does not move while constantly observing lvis evo device marker positions during the coiling procedure to ensure that the device does not migrate from its deployed position.23.Use the guidewire and microcatheter to access the aneurysm through the lvis evo device cells.Warning: observe lvis evo device marker position during placement of the microcatheter into the aneurysm to ensure that the lvis evo device does not migrate or dislodge from its deployed position.Note: access to the aneurysm may be facilitated by the use of a microcatheter that has been shaped.24.After the microcatheter is positioned within the aneurysm, detachable coils may be delivered into the aneurysm according to conventional methods.25.Warning: observe lvis evo device marker position during the coiling procedure to ensure that the device does not migrate from its deployed position.After placing the last coil, verify that the lvis evo device has remained patent and properly positioned.Advance a guidewire, if necessary, to the microcatheter tip and carefully remove the microcatheter.Note: a microcatheter may be positioned into the aneurysm sac prior to delivery of the lvis evo device.The microcatheter will be supported by the lvis evo device during delivery of embolic coiling.After completing the coiling, the coiling microcatheter should be carefully removed to avoid dislodging the lvis evo device.26.After completing the procedure, withdraw and discard all applicable accessory devices.27.Caution: carefully watch the lvis evo device distal and proximal markers when passing through the deployed lvis evo device with embolic coiling microcatheters to avoid displacing the lvis evo device.Procedure note medical review: procedure note medical review for complaint (b)(4).A detailed review of the procedure note has been performed for complaint (b)(4).Review data indicates an emergency room visit due to sudden onset of headaches.A ct angiography then highlighted a right basi-frontal hematoma and a subarachnoid hemorrhage fisher scale iv following rupture of an anterior communicating artery aneurysm and an unruptured right cerebral bifurcation aneurysm measuring 4.5 mm in length.An emergency coil embolization of the ruptured aneurysm was performed.Arteriography also confirmed the presence of a second right cerebral bifurcation aneurysm.Post-operative data indicates that the patient described an improvement in her hemiparesis and a check-up ct angiography found complete exclusion of the anterior communicating artery aneurysm and an increase in the right cerebral aneurysm measuring 6 mm in length.An embolization of this second aneurysm was performed with placement of an endoprosthesis.Follow-up check-up indicates that found no anomaly and the patient returned home the same day.Patient data reflects that the patient fell without loss of consciousness.Data review further indicates the presence of a voluminous right femoral hematoma on the site of the (b)(6) catheterization.A brain mri found an ischemic stroke in the context of thrombosis of the stent placed in the right cerebral artery.Patient underwent emergency thrombectomy.For the procedure, the patient was then intubated and put on mechanical ventilation.Unfortunately, a failed stent thrombectomy and iatrogenic dissection of the artery followed.A check-up brain ct scan was carried out at 24 hours provided finding of a right superficial and deep ischemic cerebral stroke next to an occlusion of the ipsilateral cerebral artery with anterior cerebral hypodensity in the context of a probable occlusion of the anterior cerebral artery.Data reflects that the patient deteriorated on the neurological level with the onset of anisocoria and stereotyped extension.The family, did not want aggressive treatment in this patient who previously expressed her wish not to be handicapped, was informed of the evolution and it was decided in this context not to perform a decompressive craniectomy.The patient then gradually evolved toward the state of clinical encephalic death which was diagnosed.Procedure note medical review conclusion for complaint (b)(4).A detailed medical review of the procedure note data has been completed for complaint (b)(4).Patient data indicates that the patient fell without loss of consciousness.Data review further indicates the presence of a voluminous right femoral hematoma on the site of the (b)(6) catheterization.Performance of a brain mri found an ischemic stroke in the context of thrombosis of the stent placed in the right cerebral artery.Patient underwent emergency thrombectomy.Thrombectomy procedure was determined to have failed with resulting iatrogenic dissection of the artery.Performance of a check-up brain ct scan revealed finding of a right superficial and deep ischemic cerebral stroke next to an occlusion of the ipsilateral cerebral artery with anterior cerebral hypodensity in the context of a probable occlusion of the anterior cerebral artery.An additional brain ct scanning was performed after injection of mannitol showed progression of the subfalcine involvement at 16 mm biased toward the left with onset of temporal engagement and hydrocephalus.The patient then gradually evolved toward the state of clinical encephalic death.The reported complaint is non-verifiable.The device was not returned to the manufacturer for analysis.
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