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

Model Number LEV3018-MVE

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

Patient Problems Confusion/ Disorientation (2553); Speech Disorder (4415); Ischemia Stroke (4418)

Event Date 03/06/2023

Event Type  Injury  

Event Description

It was reported for a patient enrolled in the sealant study: pre procedure neurological evaluation: mrs score 0 - nihss score 0.Measurement of the aneurysm: h-w-n (5.6x 3.23 x 2.6).Parent artery (distally 1.90 mm and proximally 2.2).Neurological history: embolisation right ica aneurysm with fd (b)(6) 2022) (b)(6) 2023 (embolization): the patient was treated for a saccular bifurcation aneurysm, located on the midline anterior communicating artery (acom).The aneurysm never ruptured and not previously treated.The treatment consisted of using a lvis evo stent, and four (4) coils were used under jailed-catheter technique.The parent artery at the end of the procedure remains without stenosis.(b)(6) 2023 (procedure day) sae1: speaking difficulty, space-time disorientation according to the description provided by the site, the event is not associated with device malfunction; it is a neurological event ¿speaking difficulty, space-time disorientation¿.In term of clinical impact, the patient is symptomatic.The event is possibly related to the lvis evo device, possibly related to the index endovascular procedure, not related to the study disease condition, it is possibly related to concurrent disease condition or treatment.The action taken for the ae are a drug treatment with ¿mannitol¿ and mri.The outcome is resolved without sequelae on 14-march-2023.15-march-2023 (discharge): patient discharged from the hospital with a neurological evaluation mrs 0, nihss 0.Additional information / physician reports received and reported: date reported: 06/03/2023 dose class according to i' art.161 of legislative decree 101/2020: class o findings: several hyperintense lesional foci in dwi (b1000) and long tr scans are detected in cortical and subcortical location, predominantly in left temporo-occipital region and to a lesser extent in fronto-parietal region homolaterally, findings of likely ischemic nature in acute phase.Regular flow signal in major intracranial arterial branches.Excluded from the circulation the known anterior communicating aneurysm treated with coils and stents.Regular volume of ventricles.Date reported: (b)(6) 2023 dose class according to i' art.161 of legislative decree 101/2020: class o findings: mri examination of the encephalon was performed with tse, flair-3d, dwi, tof-3d, pcasl and swi technique, using tl-dependent multiplanar scans, t2, diffusion and magnetic susceptibility (t2*).Performed comparative evaluation with previous encephalic mri investigation with angio sequences performed on (b)(6) 2023 at this o.U.And present in the relevant digital archives.At the current inspection, the known and circumscribed ischemic lesional foci located in the left temporo-occipital region and to a lesser extent in the ipsilateral fronto-parietal region appear slightly more ringed.Pervious ii proximal tract of major intracranial arterial axes in the absence of frank flow changes (rcbf) on smdc perfusion study (pcasl).No other substantial changes in known mri findings compared with baseline mri investigation.Date of completion: (b)(6)2023 19:34: stable patient.No new-onset neurologic deficits.Left gluteal dressing is performed, as per plastic surgery consultation performed on (b)(6) 2023.Hemochromocytometric check is scheduled on the morning of tomorrow (b)(6) 2023.(b)(6) 2023 20:21: stable patient.+(b)(6) 2023 10:38 am: patient stable, in good clinical condition.Reviewed the findings of the blood thromocytometric examination performed in the morning today.Patient was taken to floor zero of pad.E to perform control encephalic ct scan.(b)(6)2023 12:16 p.M.: patient returns to the ward after performing encephalic ct scan.Review of the findings of the same.(b)(6) 2023 15:01: patient discharged to home.

Manufacturer Narrative

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.The device was implanted in the patient and not returned to the manufacturer for evaluation.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.The event as described could not be confirmed.

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.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 un-sheath 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 conclusion: a medical review of the procedure data was performed.Data review indicates that as part of the sealant study, the patient received treatment with an lvis evo device for a saccular bifurcation aneurysm located within the anterior communication artery.Index surgical procedure date is march 6, 2023.The reported event occurred on march 6, 2023, with the patient experiencing speaking difficulty, space time disorientation.On march 8, 2023, a diagnostic mri was performed of the encephalon with tse, flair-3d, dwi, tof-3d, pcasl and swi technique, using tl-dependent multiplanar scans, t2, diffusion and magnetic susceptibility (t2*).The known and circumscribed ischemic lesional foci located in the left temporo-occipital region and to a lesser extent in the ipsilateral fronto-parietal region appear slightly more ringed.Data review indicates that no other substantial changes in the mri findings compared with baseline mri investigation.The reported ae was treated with mannitol and the outcome was reported as resolved without sequelae on march 14, 2023.Based on the review, the relationship of the event to the lvis evo device cannot be ruled.However, no device malfunction was reported that was associated with and/or contributed to the reported ae.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

Please see section h10 for investigation results.

• Brand Name: LVIS EVO
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• 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: 18871482
• MDR Text Key: 337292723
• Report Number: 2032493-2024-00205
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103463
• UDI-Public: (01)00842429103463(11)220203(17)250131(10)0000151369
• 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: 03/29/2024

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: LEV3018-MVE
• Device Lot Number: 0000151369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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
• Treatment: HYDROFRAME 10; HYDROSOFT 3D COIL
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female