MAUDE Adverse Event Report: MICROVENTION, INC. LVIS EVO; INTRALUMINAL DEVICES

Model Number LEV3028-MVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paralysis (1997)

Event Date 10/25/2023

Event Type  Injury  

Manufacturer Narrative

Investigation findings 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, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.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.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of 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): 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.Investigation conclusions: complaint confirmed.Non-verifiable.Investigation conclusion.The reported event is non-verifiable.The physical device was not available for evaluation to determine if a condition existed that would have caused or contributed to event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.This information may be updated if additional information is provided at a later date.

Event Description

As reported through the sealant study, the patient was treated for a saccular bifurcation aneurysm, located on the left middle cerebral artery (mca).The aneurysm never ruptured and not previously treated.The treatment consisted of using a stent lvis evo and 3 hydrocoils were used during the procedure under jailed-catheter technique.30 minutes post procedure, motoric aphasia and hemiplegia of the right side was reported.After tirofiban intravenously it was completely resolved in 2 hours.The outcome is resolved without sequelae.

Manufacturer Narrative

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: 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.Post procedure data medical review, (b)(4), 11-15-2023.A detailed post procedure data medical review has been completed for complaint (b)(4).Data review indicates that the procedure note is dated (b)(6), 2023.As part of the sealant study, the patient was treated for a saccular bifurcation aneurysm, which was located on the left middle cerebral artery (mca).Data review indicates that the aneurysm never ruptured and was not previously treated.Post procedure data review further indicates that the treatment for the patient consisted of utilizing an lvis evo 3x24 stent and three hydrocoils during the performance of this procedure under jailed catheter technique.Data review indicates the lvis evo 3x 24 device was inserted into the superior truncus on m1 with constriction seen at the level of the of the aneurysm neck.Procedure data review indicates that the operative procedure was performed on (b)(6) 2023.On the same day (b)(6) 2023, it was reported that 30 minutes after the completion of the procedure, the patient experienced a motoric aphasia and hemiplegia of the right side.Post procedure data further indicates that the patient received therapeutic treatment with aggrastat iv administered to 65 kg body weight with a bolus over three minutes and a subsequent maintenance dose of 12 ml per hour.The post-procedure outcomes was reported as aphasia and hemiplegia, which completely regressed with the administration of aggrastat i.V., on (b)(6) 2023.Post procedure data review indicates the report of occurrence of eye flickering in both eyes for 15 minutes occurring twenty-four hours post-operatively.Performance of an mri indicates the event was most likely due to an in-stent thrombosis after the procedure and was treatment with i.V.Tirofiban.After 15 minutes the symptoms were spontaneously and completely regressed.Patient was discharged to home at the request of the patient.Based on the review of the available post procedure note data and in my medical opinion, the relationship to the lvis evo device cannot be ruled out and the reported events are most likely associated with an in-stent thrombosis.Data review indicates that there is no lvis evo device malfunction reported and/or there is no device malfunction reported associated with or contributing to the reported adverse event.A post procedure data medical review was performed.Based on the review of the available post procedure note data, the relationship to the lvis evo device cannot be ruled out and the reported events are most likely associated with an in-stent thrombosis.However, the data review indicates that there is no lvis evo device malfunction reported and/or there is no device malfunction reported associated with or contributing to the reported adverse event.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.

Event Description

See h10.

• Brand Name: LVIS EVO
• Type of Device: INTRALUMINAL DEVICES
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18071100
• MDR Text Key: 327356143
• Report Number: 2032493-2023-01033
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103487
• UDI-Public: (01)00842429103487(11)230302(17)260228(10)0000327563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LEV3028-MVE
• Device Lot Number: 0000327563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 56 YR
• Patient Sex: Female