MAUDE Adverse Event Report: MICROVENTION INC. LVIS EVO; INTRACRANIAL COIL-ASSIST STENT

Model Number LEV2517

Device Problems Activation Failure (3270); Activation Problem (4042); Device Stenosis (4066)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 11/08/2022

Event Type  Injury  

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 stent was implanted in the patient and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided; however, operative notes were received.The investigation is ongoing.Upon completion, of the investigation, a supplemental report will be submitted.The instructions for use (ifu) identifies thrombus as a potential complication associated with the use of the device.

Event Description

As reported through a sealant study, on (b)(6) 2022, the patient was treated for a saccular bifurcation aneurysm located on the left anterior communicating artery (aca).The aneurysm never ruptured and was not previously treated.The treatment consisted of using a lvis evo stent, 4 hydrosoft 3d, 2 hydroframe 10 were used (jailing left v4, balloon-assisted right v4/ba).The parent artery at the end of the procedure remains without stenosis.Measurement of the aneurysm: h-w-n (7x 5.4x 4.5).Parent artery (distally 2.2 mm and proximally 3) during the procedure, an incident occurred that reported stent failed to open and a in stent thrombosis occurred.The thrombosis resolved and the stent expanded after pta was performed during the procedure.According to the description provided by the site, the event is not serious.It is associated with device malfunction; it is not a neurological event.In term of clinical impact, the patient is asymptomatic.The event is possibly related to the lvis evo study device.The event is not related to the hydrocoils study device, not related to the ancillary device and not related to index endovascular procedure.Is also not related to the study disease condition and not related to concurrent disease condition or treatment.The actions taken for the ae are a drug treatment with ¿eptifibatid¿ and endovascular treatment with ¿pta¿.The outcome is resolved without sequela on (b)(6) 2022.On (b)(6) 2023, during a 12 and 6 month follow-up, the neurological evaluation of the patient is mrs 0, nihss 0.

Manufacturer Narrative

A medical review of the post-operative treatment notes was performed.The note is dated (b)(6) 2022.As part of the sealant study, the patient underwent an embolization procedure for the treatment of an unruptured saccular bifurcation aneurysm located on the left anterior communicating artery with the utilization of a lvis evo which was performed on (b)(6) 2023.Data review indicated that on november 8, 2023 (day of procedure), the operative physician reported that during controlled angiography and after performance of coil embolization, there was evidence of a thrombus in the stent distally during the procedure with immediate treatment of the thrombus with i.V.Administration of integrilin (eptifibatid) and endovascular treatment with pta.After detection of the thrombi, the operative physician performed remodeling of the stent using a scepter xc.Data review indicated resolution of the event following therapeutic treatment with integrilin occurred on (b)(6) 2023.After therapeutic treatment, there was no evidence of thrombi or vascular occlusion with no evidence of complications as reported.There is no report of device malfunction within the operative report note data.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.

Event Description

See h10.

Manufacturer Narrative

A correction to the event description was received from the customer on (b)(6) 2023 that stated the original information stating that the aneurysm is located at the left anterior communication artery is not correct.The correct location for the aneurysm is on the basilar trunk.

Manufacturer Narrative

Correction: d6: the original implanted date (b)(6) 2023, had an incorrect year.The correct year is (b)(6) 2022.The date should be (b)(6) 2022.H11: updates were made to the investigation.The updates are stated as follows: post-operative treatment note medical review, a detailed medical review of the post-operative treatment notes has been performed on (b)(6) 2023.Data review of the post-operative treatment note data indicates that the note is dated (b)(6) 2022.As part of the sealant study, the patient underwent an embolization procedure for the treatment of an unruptured saccular bifurcation aneurysm located on the left anterior communicating artery with the utilization of a lvis evo which was performed on (b)(6) 2022.Data review indicates that on (b)(6) 2022 (day of procedure) the operative physician reported that during controlled angiography and after performance of coil embolization, there was evidence of a thrombus in the stent distally during the procedure with immediate treatment of the thrombus with i.V.Administration of integrilin (eptifibatid) and endovascular treatment with pta.After detection of the thrombi, data review indicates that the operative physician performed remodeling of the stent using a scepter xc.Data review indicates resolution of the event following therapeutic treatment with integrilin occurred on (b)(6) 2022.After therapeutic treatment, there was no evidence of thrombi or vascular occlusion with no evidence of complications as reported.Based on my review and in my medical opinion, the post-operative report data indicates physician reported remodeling of the stent as a result of the stent failing to open with intraoperative angiography performed after coil embolization indication evidence of thrombi in the stent distally which indicates clinically a possible relationship to the lvis evo device which cannot be ruled out.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.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.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.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 conclusion a medical review of the post-operative treatment notes was performed.Based on the review, the post-operative report data indicates the physician reported remodeling of the stent as a result of the stent failing to open with intraoperative angiography performed after coil embolization indication evidence of thrombi in the stent distally.This indicates clinically a possible relationship to the lvis evo device which cannot be ruled out.However, 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.

Manufacturer Narrative

H11 a review of the medical record was performed, and the investigation was updated.The updated investigation is stated as follows: procedure/medical information review: post-operative treatment note medical review, a detailed medical review of the post-operative treatment notes has been performed on (b)(6) 2023.Data review of the post-operative treatment note data indicates that the note is dated (b)(6) 2022.As part of the sealant study, the patient underwent an embolization procedure for the treatment of an unruptured saccular bifurcation aneurysm located on the left anterior communicating artery with the utilization of a lvis evo which was performed on (b)(6) 2023.Data review indicates that on (b)(6) 2023 (day of procedure) the operative physician reported that during controlled angiography and after performance of coil embolization, there was evidence of a thrombus in the stent distally during the procedure with immediate treatment of the thrombus with i.V.Administration of integrilin (eptifibatid) and endovascular treatment with pta.After detection of the thrombi, data review indicates that the operative physician performed remodeling of the stent using a scepter xc.Data review indicates resolution of the event following therapeutic treatment with integrilin occurred on november 8, 2023.After therapeutic treatment, there was no evidence of thrombi or vascular occlusion with no evidence of complications as reported.Based on my review and in my medical opinion, the post-operative report data indicates physician reported remodeling of the stent as a result of the stent failing to open with intraoperative angiography performed after coil embolization indication evidence of thrombi in the stent distally which indicates clinically a possible relationship to the lvis evo device which cannot be ruled out.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.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.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.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 conclusion a medical review of the post-operative treatment notes was performed.Based on the review, the post-operative report data indicates the physician reported remodeling of the stent as a result of the stent failing to open with intraoperative angiography performed after coil embolization indication evidence of thrombi in the stent distally.This indicates clinically a possible relationship to the lvis evo device which cannot be ruled out.However, 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.

Event Description

See h6 and h10.

• Brand Name: LVIS EVO
• Type of Device: INTRACRANIAL COIL-ASSIST STENT
• 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: 18298333
• MDR Text Key: 330114367
• Report Number: 2032493-2023-01103
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103432
• UDI-Public: (01)00842429103432(11)220420(17)250331(10)0000177349
• 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,Followup,Followup,Followup
• Report Date: 02/22/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: LEV2517
• Device Lot Number: 0000177349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/09/2023
• Supplement Dates Manufacturer Received: 12/12/2023; 12/20/2023; 01/24/2024; 02/13/2024
• Supplement Dates FDA Received: 12/18/2023; 01/05/2024; 02/07/2024; 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female