| Model Number LEV2517 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
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| Event Date 10/14/2022 |
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Event Type
Injury
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Event Description
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As reported through the clinical study (b)(4) , patient: (b)(6).The patient was treated for a saccular bifurcation aneurysm, located on the left middle cerebral artery mca.The aneurysm never ruptured and was not previously treated.The treatment consisted of using multiple embolization coils and utilizing under balloon-assist technique before stenting.Two lvis evo lev2517 stents were then placed.It was reported all stents were fully implanted and spontaneously expanded.The procedure was uneventful, but the stent thrombosed a couple of hours later despite dual antiplatelets and good activation on multiplate test.Intervention was performed using a third stent to reopen the occluded vessel.This event is not associated to a device malfunction; however, the relatedness to the thrombus / occlusion is unknown.According to the description provided by the study site, the patient is asymptomatic for this event.It is unknown at which stent the thrombus occurred, and which stent was used as intervention.
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Manufacturer Narrative
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A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The devices were implanted in the patient and not returned to the manufacturer for evaluation.Procedural or medical imaging were not provided.The incident as described could not be confirmed.The instructions for use (ifu) identifies thrombus as a potential complication associated with the use of the device.
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Manufacturer Narrative
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Please note this follow up report is also being submitted to include correction from fei based to cfn based.Fei was selected in error on our initial report.H11: corrected - updated information in b5, b7, d1, d2, d4, h4.Please note that d3 and g1 remain the same as previously submitted.H10: a supplemental and final report will be filed following the completion of the complaint investigation.
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Event Description
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As reported through the clinical study [sealant], site: 11, patient: 11-002_sae1.The patient was treated for a saccular bifurcation aneurysm, located on the left middle cerebral artery (mca).The aneurysm never ruptured and was not previously treated.The treatment consisted of using multiple embolization coils and utilizing under balloon-assist technique before stenting.Two lvis evo lev2517 stents were then placed.It was reported all stents were fully implanted and spontaneously expanded.The procedure was uneventful, but the stent thrombosed a couple of hours later despite dual antiplatelets and good activation on multiplate test.Intervention was performed using a third stent to reopen the occluded vessel.This event is not associated to a device malfunction; however, the relatedness to the thrombus / occlusion is unknown.According to the description provided by the study site, the patient is asymptomatic for this event.It is unknown at which stent the thrombus occurred, and which stent was used as intervention.Additional clarification received indicated: clinical deterioration reported two hours post procedure in the wake up room.Cta revealed the lvis evo 2512 stent no longer patent and was thrombosed.The lvis evo 2517 was placed temporarily in the superior division branch during coiling but the size chosen was too long to be released in the inferior division branch which was the stented artery.The access to this artery through the stent was very difficult due to the acute angulation.Iv integrilin was not sufficient to allow resolution of the thrombus, this could be achieved with an acclino stent followed by an in-stent pta that enabled complete and stable recanalization.The device connected to this report has been corrected to lvis evo 2.5x12 mm, lot 0000093533 based on this new information.Lvis evo lev2517 will be listed as ancillary but did not remain in patient.
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Manufacturer Narrative
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A detailed medical review of the procedure notes provided for this incident has been performed.Data indicates that the patient was diagnosed with small aneurysmal subarachnoid hemorrhage postintervention due to aneurysm of the left middle cerebral artery.Stenting and coiling was performed via a right femoral approach.Immediately after treatment, there was increasing vigilance disturbance.Emergency imaging by schadel ct and ct angiography revealed occlusion of the middle cerebral artery.Emergency imaging by schadel ct and ct angiography revealed occlusion of the middle cerebral artery.Immediate mechanical thrombectomy was performed.In the course of the inpatient stay, a febrile infection with increased inflammation values occurred.After diagnosis of a nitrite-positive urinary tract infection, therapy included tazobac.Patient improved with tazobac therapy.Physician requested continued use of double antiplatelet therapy.An inpatient / outpatient follow-up has been scheduled with control by catheter angiography.The report does not provide any evidence of device malfunction.A visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation.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.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.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.Similar incidents were determined by identifying incidents within the same product family (lvis evo) with the same medical device problem (no device malfunction), and with a similar procedure outcome/patient effect (during or post-surgical thrombus / vessel occlusion / with or without sequalae, regardless or patient outcome).A review of the risk analysis documents was performed, and the risks associated with this device issue have been addressed per microvention inc.Quality system procedures.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.
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Event Description
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As reported through the clinical study [sealant], site: 11, patient: (b)(6).The patient was treated for a saccular bifurcation aneurysm, located on the left middle cerebral artery (mca).The aneurysm never ruptured and was not previously treated.The treatment consisted of using multiple embolization coils and utilizing under balloon-assist technique before stenting.Two lvis evo lev2517 stents were then placed.It was reported all stents were fully implanted and spontaneously expanded.The procedure was uneventful, but the stent thrombosed a couple of hours later despite dual antiplatelets and good activation on multiplate test.Clinical deterioration reported two hours post procedure in the wake up room.Cta revealed the lvis evo 2512 stent no longer patent and was thrombosed.The lvis evo 2517 was placed temporarily in the superior division branch during coiling but the size chosen was too long to be released in the inferior division branch which was the stented artery.The access to this artery through the stent was very difficult due to the acute angulation.Iv integrilin was not sufficient to allow resolution of the thrombus, this could be achieved with an acclino stent followed by an in-stent pta that enabled complete and stable recanalization.Intervention was performed using a third stent to reopen the occluded vessel.This event is not associated to a device malfunction; however, the relatedness to the thrombus / occlusion is unknown.According to the description provided by the study site, the patient is asymptomatic for this event.Clarification was received correcting lot numbers reported.This report is corrected to show lvis evo lev2517, lot number 0000157045, in which the stent was fully implanted and spontaneously expanded but with stent occlusion.Information received notes on (b)(6) 2022 (discharge): patient discharged from the hospital with a neurological evaluation; mrs 4, nihss score 14.On (b)(6) 2023 (fu 12 ± 6 month): the neurological evaluation of the patient is mrs 3.
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Manufacturer Narrative
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Event description and device information updated based on clarification received h10: a detailed medical review of the procedure notes for complaint (b)(4) has been performed.Data indicates that the patient was diagnosed with small aneurysmal subarachnoid hemorrhage postintervention due to aneurysm of the left middle cerebral artery.Stenting and coiling was performed via a right femoral approach.Immediately after treatment, there was increasing vigilance disturbance.Emergency imaging by schadel ct and ct angiography revealed occlusion of the middle cerebral artery.Emergency imaging by schadel ct and ct angiography revealed occlusion of the middle cerebral artery.Immediate mechanical thrombectomy was performed.In the course of the inpatient stay, a febrile infection with increased inflammation values occurred.After diagnosis of a nitrite-positive urinary tract infection, therapy included tazobac.Patient improved with tazobac therapy.Physician requested continued use of double antiplatelet therapy.An inpatient / outpatient follow-up has been scheduled with control by catheter angiography.The report does not provide any evidence of device malfunction.Items returned: n/a 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: listed below are the complaints from the last 2 years recorded in the complaint handling system with this batch number at the time of this investigation: (b)(4) based on a review of the last 2 years of complaint data, and at the time of this investigation, no systemic issues have been identified for this batch number that would have caused or contributed to the reported event.Ifu review (additional information can be found in the ifu): 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 warnings should unusual resistance be felt at any time during access or removal, the introducer/guide catheter/microcatheter and lvis evo device should be removed as a single unit.Applying excessive force during delivery or retrieval of the lvis evo device can potentially result in loss or damage to the device and delivery components.It is imperative to use the lvis evo device with compatible microcatheters.If repeated friction is encountered during lvis evo device delivery, verify microcatheter is not kinked or in extremely tortuous anatomy.Confirm that the microcatheter does not ovalize.Confirm that there is adequate sterile flush solution.Do not reposition the lvis evo device in the parent vessel without fully retrieving the device.The lvis evo device must be retrieved into the microcatheter and re-deployed at the desired target location or removed completely from the patient.Precautions exercise caution when crossing the deployed/detached lvis evo device with adjunctive devices such as guidewires, catheters, microcatheters or balloon catheters to avoid disrupting the device geometry and device placement.Directions for use 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.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.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.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.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.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.A detailed medical review of the procedure notes for complaint (b)(4) was performed.An inpatient / outpatient follow-up has been scheduled with control by catheter angiography.No device malfunction was reported.Without the return and physical evaluation of the device, the investigation cannot determine if a condition exists that would have caused or contributed to the reported event.
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Search Alerts/Recalls
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