MAUDE Adverse Event Report: MICROVENTION, INC. LVIS; INTRACRANIAL NEUROVASCULAR STENT

Model Number	212928-LVIS-D-HDE
Medical Device Problem Codes	Retraction Problem (1536); Activation Failure (3270)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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 an 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): adverse events possible adverse events 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 device should be removed as a single unit.Applying excessive force during delivery or retrieval of the lvis device can potentially result in loss or damage to the device and delivery components.It is imperative to use the lvis device with compatible microcatheters or occlusion balloons.If repeated friction is encountered during lvis 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 device in the parent vessel without fully retrieving the device.The lvis 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 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 device from within the introducer into the microcatheter.Warning: do not torque the delivery wire while advancing or retracting the lvis 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 device delivery or manipulation, withdraw the unit and select a new lvis device.18.Position the lvis device for deployment by aligning the lvis implant distal radiopaque end markers approximately 7 mm 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 device to achieve full expansion and good vessel apposition.Note: slowly advancing the lvis device while adjusting the microcatheter position will ensure accurate deployment.Maintain simultaneous control of the lvis 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 device is not recommended and may result in device elongation.19.If lvis device positioning is not satisfactory, the lvis device may be recaptured and repositioned if it is not fully deployed.The lvis device may be recaptured until the point where the proximal end of the lvis device markers is aligned 3 mm proximally with the microcatheter distal marker band (approximately 75% deployed).Caution: if resistance is felt while recapturing the lvis device, do not continue to recapture the device.Withdraw the microcatheter slightly to unsheath the lvis device (without exceeding the recapture limit), and then attempt to recapture the lvis device.Caution: the lvis device must not be re-deployed more than three times.Note: the lvis device delivery wire should not be utilized as a guidewire.Do not torque the lvis device.A torque device should not be used.20.If lvis device positioning is satisfactory, carefully retract the microcatheter and advance the delivery wire together, to allow the lvis device to deploy across the neck of the aneurysm.Ensure the device proximal radiopaque end markers are approximately 7 mm proximal to the aneurysm neck to ensure an adequate landing zone.The lvis device will expand and total length may foreshorten up to 55% from its undeployed length 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 on each side of the aneurysm neck or target location to ensure appropriate neck coverage.Warning: do not detach the lvis 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 device to maintain access through the lvis device.Remove and discard the delivery wire.Warning: the lvis device delivery wire should not be utilized as a guidewire.Do not torque the lvis device.A torque device should not be used.23.Use the guidewire and microcatheter to access the aneurysm through the lvis device cells.Warning: observe lvis device marker position during placement of the microcatheter into the aneurysm to ensure that the lvis device does not migrate or dislodge from its deployed position.24.After the microcatheter is positioned within the aneurysm, detachable coils may be delivered into the aneurysm according to conventional methods.Warning: observe lvis device marker position during the coiling procedure to ensure that the device does not migrate from its deployed position.25.After placing the last coil, verify that the lvis device has remained patent and properly positioned.Advance a guidewire to the microcatheter tip and carefully remove the microcatheter through the lvis device cells.Note: a microcatheter may be positioned into the aneurysm sac prior to delivery of the lvis device.The microcatheter will be supported by the lvis device during delivery of embolic coiling.After completing the coiling, the microcatheter should be carefully removed to avoid dislodging the lvis device.27.Caution: carefully watch the lvis device distal and proximal markers when passing through the deployed lvis device with embolic coiling microcatheters to avoid displacing the lvis device.
Event or Problem Description
As reported through the clinical study lvis pas: ae/event term: difficulty getting the proximal aspect of the device to open due to severe tortuosity.Index procedure summary: during the index procedure on (b)(6) 2018 to treat large, wide-necked ophthalmic ica aneurysm, lvis 4x28 was deployed from the ica terminus, across the neck of the aneurysm where the device was packed in, and ultimately into the cavernous segment of the ica.Given severe tortuosity, some difficulty occurred with getting the proximal aspect of the device to open.It was decided to complete the coiling portion of the procedure to address the proximal aspect of the device without having an adjacent microcatheter present.After fully deploying and detaching the 9x30, coiling proceed with 5 additional axium coils as follows: 7x30 3d, 6x20 3d prime, 5x15 3d prime, 4x12 3d prime, 3x10 3d.The echelon was then removed.A scepter xc 4x11 balloon was advanced over a synchro wire in an attempt to angioplasty the proximal aspect of the lvis.Given the acuity of the angles, could not select the interior of the device; however, manipulated the balloon alongside device.This provided enough forward force to push the proximal aspect into a more vessel-conforming position.Final angiography showed adequate wall apposition both distally and proximally.In the process of trying to advance the scepter xc into the device, the force of the navien entering the proximal cavernous segment resulted in the development of a small, slow flow carotid cavernous fistula (ccf).There was no intracranial extravasation, assessed as small asymptomatic ccf.At this point, reversed heparin and observed.Considered balloon tamponade but it was decided that the risk of further vessel manipulation was not prudent given that intracranial flow was normal.Final angiography showed near complete aneurysm occlusion and normal cerebral perfusion.There were no thrombo-emboli.The catheters were withdrawn.Hemostasis was achieved using a 6f angioseal device after right femoral angiography.A sterile dressing was applied.The patient was awakened from anesthesia and extubated.Neurological and ophthalmological examination were normal postoperatively.The patient was transferred to recovery and ultimately the neuro icu for overnight observation.Site reported technical event summary: on the day of procedure on (b)(6) 2018, it was noted difficulty getting the proximal aspect of the device to open due to severe tortuosity.Site reported the technical event as incomplete opening of the lvis device proximal to the aneurysm.Subject did not require other treatment/intervention as a result of the malfunction/deficiency.Technical event could not have led to a serious adverse device effect.Technical event was not associated with an ae.
Additional Manufacturer Narrative
Supplemental information received.Please see b3, b4, b5 and h6.
Event or Problem Description
Based on independent reviewer/ core-lab adjudicator review: 100% in-stent stenosis was noted; the left ica became completely occluded on the 5 year follow up.From the skull base through the stent.Patient was asymptomatic, stent stenosis found on routine imaging at 5 years.This is not rare.If people have good collaterals, this patient definitely had a good anterior communicating artery.Patient had 7 day follow up from brain aneurysm treatment on (b)(6) 2018.Patient was advised as required to take clopidogrel for 3 months post procedure and asa life-long to prevent delayed thromboembolic complications related to device use.Based on the information provided on ae form, no treatment was provided and event was considered with outcome of resolved without sequelae on (b)(6) 2023.

• Brand Name: LVIS
• Common Device Name: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656
• MDR Report Key: 20553177
• Report Number: 2032493-2024-00782
• Device Sequence Number: 14225170
• Product Code: QCA
• UDI-Device Identifier: 00816777026019
• UDI-Public: (01)00816777026019(11)170613(17)200531(10)170613184
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P170013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 212928-LVIS-D-HDE
• Device Lot Number: 170613184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5 AXIUM COILS.; 6F ANGIOSEAL.; ECHELON MICROCATHETER.; SCEPTER XC 4X11 BALLOON.
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White