MAUDE Adverse Event Report: MICROVENTION, INC LVIS EVO; STENT, VASCULAR, INTRACRANIAL

Model Number LEV3024

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

Patient Problem Stenosis (2263)

Event Date 10/02/2023

Event Type  Injury  

Event Description

It was reported that: a female patient was selected for treatment with stent-assisted coiling for a bastop aneurysm.Patient was pre-loaded for 5 days with prasugrel.On day of treatment the pru was tested with means of verifynow and found to be correct for stent placement.After successful placement of a lev3024 the control run looked perfect.Patient was put on dual antiplatelet per standard protocol of the university clinic: askal (aspirine) and prasugrel.At the 6-month follow-up, a diagnostic dsa was planned as part of the standard procedure in the hospital.During this dsa it was found that a severe in-stent stenosis had formed inside the lev3024 and stenosis in the p1 branch and art.Basilaris.The percentage of stenosis is: p1 segment: >50% and basilar art: 25%.Neurologically this patient is doing fine.It was decided to place the patient on single antiplatelet with aspirine only.Information received notes that the exact implant and 6 month follow up date are unknown at this time.

Manufacturer Narrative

The device remains implanted and therefore not available for return and investigation by the manufacturer.However, imaging was provided.The investigation is ongoing.Upon completion of the investigation, a supplemental report will be submitted.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.

Event Description

It was reported that: a female patient was selected for treatment with stent-assisted coiling for a bastop aneurysm.Patient was pre-loaded for 5 days with prasugrel.On day of treatment the pru was tested with means of verifynow and found to be correct for stent placement.After successful placement of a lev3024 the control run looked perfect.Patient was put on dual antiplatelet per standard protocol of the university clinic: askal (aspirine) and prasugrel.At the 6-month follow-up, a diagnostic dsa was planned as part of the standard procedure in the hospital.During this dsa it was found that a severe in-stent stenosis had formed inside the lev3024 and stenosis in the p1 branch and art.Basilaris.The percentage of stenosis is: p1 segment: >50% and basilar art: 25%.Neurologically this patient is doing fine.It was decided to place the patient on single antiplatelet with aspirine only.Additional information received notes original implant date: (b)(6) 2023 and follow up date: 2 oct 2023.

Manufacturer Narrative

Procedure/medical information / imaging review: two videos are supplied.They are not marked as to date or time.(b)(6) immediate post-implant: 17-second video of dsa of basilar artery, with contrast, subtracted and unsubtracted, in ap and oblique projections.There is a coil mass in a 4-5 mm basilar tip aneurysm.An lvis evo is faintly seen (because the images are subtracted and there is contrast), spanning from the right p2 segment of the right pca down to the mid-basilar.It is difficult to comment on apposition, but it appears ok.A loop of coil is outside the aneurysm, in the origin of the left p1, but there is no clot and flow to the left pca is not impaired.No contrast enters the aneurysm.(b)(6) 6 mo fu: 22-second video of dsa of basilar artery, with contrast, subtracted and unsubtracted, in ap and oblique projections.There is an approximately 50% stenosis of the proximal 7-8 mm of the lvis evo; there is approximately 60-65% in-stent stenosis at the level of the right p1.The coil mass is ¿looser¿ than at the time of the procedure, but no contrast enters the aneurysm; the short tail of the coil that was in the origin of the left p1 has migrated to the basilar tip, while other small loops remain in the origin of the left p1.No clot is seen.These videos do not explain why the in-stent stenosis occurred.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: 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.Two videos from the procedure were provided for review.The videos are not marked as to date or time.The review of the videos are as follows: p23-5035 immediate post-implant: 17-second video of dsa of basilar artery, with contrast, subtracted and unsubtracted, in ap and oblique projections.There is a coil mass in a 4-5 mm basilar tip aneurysm.An lvis evo is faintly seen (because the images are subtracted and there is contrast), spanning from the right p2 segment of the right pca down to the mid-basilar.It is difficult to comment on apposition, but it appears ok.A loop of coil is outside the aneurysm, in the origin of the left p1, but there is no clot and flow to the left pca is not impaired.No contrast enters the aneurysm.P23-5035 6 mo fu: 22-second video of dsa of basilar artery, with contrast, subtracted and unsubtracted, in ap and oblique projections.There is an approximately 50% stenosis of the proximal 7-8 mm of the lvis evo; there is approximately 60-65% in-stent stenosis at the level of the right p1.The coil mass is ¿looser¿ than at the time of the procedure, but no contrast enters the aneurysm; the short tail of the coil that was in the origin of the left p1 has migrated to the basilar tip, while other small loops remain in the origin of the left p1.No clot is seen.These videos confirm that the in-stent stenosis did occur, but do not explain the reason as to why the in-stent stenosis occurred.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.

• Brand Name: LVIS EVO
• Type of Device: STENT, VASCULAR, INTRACRANIAL
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 17962228
• MDR Text Key: 326005554
• Report Number: 2032493-2023-00991
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103470
• UDI-Public: (01)00842429103470(11)211220(17)241130(10)0000136598
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

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: LEV3024
• Device Lot Number: 0000136598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female