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

Model Number LEV3517-MVE

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

Patient Problem Ruptured Aneurysm (4436)

Event Date 06/20/2023

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device remains within the patient and not returned to the manufacturer for evaluation.Procedural or medical imaging were requested and not provided.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.If imaging is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.

Event Description

As reported through the sealant study, the patient was treated for a saccular sidewall aneurysm on (b)(6) 2023, located on the left internal carotid artery (ica) supraclinoid.The aneurysm never ruptured and not previously treated.The treatment consisted of using a stent lvis evo and hydrosoft helical coils were used during the procedure under jailed-catheter technique.The parent artery at the end of the procedure remains without stenosis.The patient was admitted for planned elective procedure on (b)(6) 2023.During the procedure, transient aneurysm rupture had occurred with no haemodynamic response.Patient woke up with no focal neurological deficit and discharged the following day.According to the description provided by the site, the event was not serious.In term of clinical impact, the patient is asymptomatic.It is a neurological event (haemorrhage due to aneurysm rupture).Event outcome was not reported.Patient discharged from the hospital on (b)(6) 2023 with a neurological evaluation; mrs 0, nihss 0.

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, nor were any images of the device provided in place of a device return.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.Imaging review, (b)(4), md, (b)(6) 2024: a dicom file dated 6/20/2023 is supplied.Right arm fluoroscopic single-shot images: a guidewire has been introduced in the right brachial artery.Left ica angiograms: dsa, subtracted and unsubtracted, with and without contrast.The procedure starts at 14h10.There is a small cylindrical left pcom aneurysm.A subsequent run at 15h05 shows an lvis evo spanning from the distal supraclinoid ica to the posterior ica cavernous siphon; it is well opened and apposed.A jailed microcatheter is being used to deploy coils in the aneurysm at 15h05.At 15h15, the aneurysm is almost entirely coiled.At 15h19, mild extravasation of contrast material into the subarachnoid space around the aneurysm/ica is seen, indicating aneurysmal rupture.At 15h24, the extravasation has slowed down.At 15h33, the extravasation has subsided.On the last angio run at 15h52, there is still no extravasation.A flat plate ¿xper¿ ct done at the completion of the procedure, of mediocre quality, shows mild subarachnoid blood and contrast in the subarachnoid space, consistent with the procedural rupture.There is no mass effect or hydrocephalus.These images do not explain why the intraprocedural aneurysm rupture occurred.The reported event is non-verifiable.Supplemental imaging was provided and reviewed as part of this investigation as follows: right arm fluoroscopic single-shot images: a guidewire has been introduced in the right brachial artery.Left ica angiograms: dsa, subtracted and unsubtracted, with and without contrast.The procedure starts at 14h10.There is a small cylindrical left pcom aneurysm.A subsequent run at 15h05 shows an lvis evo spanning from the distal supraclinoid ica to the posterior ica cavernous siphon; it is well opened and apposed.A jailed microcatheter is being used to deploy coils in the aneurysm at 15h05.At 15h15, the aneurysm is almost entirely coiled.At 15h19, mild extravasation of contrast material into the subarachnoid space around the aneurysm/ica is seen, indicating aneurysmal rupture.At 15h24, the extravasation has slowed down.At 15h33, the extravasation has subsided.On the last angio run at 15h52, there is still no extravasation.A flat plate ¿xper¿ ct done at the completion of the procedure, of mediocre quality, shows mild subarachnoid blood and contrast in the subarachnoid space, consistent with the procedural rupture.There is no mass effect or hydrocephalus.These images do not explain why the intraprocedural aneurysm rupture occurred.The physical device was not available for evaluation to determine if a condition existed that would have caused or contributed to event.

Event Description

Additional information received indicated: angiogram following balloon deflation showed complete occlusion of the aneurysm was shown at the end of the procedure with normal filling of the distal ica vessels.In view of no haemodynamic response and no significant blood on the post procedure xper'ct a decision was made to extubate the patient.Tr band to rt radial puncture.Images received for evaluation.

Event Description

Additional information received indicated: rt radial puncture - 6 fr sheath (prelude ideal).Radial cocktail (5000 iu heparin + 2.5 mgs verapamil + 200 mcg lsoket) via radial sheath.6-fr benchmark 105 ems positioned in the distal cervical segment of the left ica.Check angiography confirms the approximately 4 mm wide neck aneurysm arising from the communicating segment of the left ica.Aneurysm catheterised with a 0.00165 microcatheter (sl10) and following deployment of a 3.5mm x 17mm lvis evo stent across the aneurysm neck the aneurysm was embolized with 4 coils (hydrosoft 2 x 1, hydrosoft - 1.5 x 2, hydrosoft 1 x 2 and target nano 1 x 1).Transient extravasation due to aneurysm rupture was shown following deployment of the third coil following which a final coil was deployed.In view of the extravasation, an attempt to position a 4mm x 11mm scepter xc within the stent across the aneurysm neck was abandoned as it displaced the proximal end of the stent.In view of this, the balloon was transiently inflated in the petrous segment of the left ica.Angiogram following balloon deflation showed complete occlusion of the aneurysm was shown at the end of the procedure with normal filling of the distal ica vessels.In view of no haemodynamic response and no significant blood on the post procedure xper'ct a decision was made to extubate the patient.Tr band to rt radial puncture.D11.Concomitant medical products added to this section.

• 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: 17431237
• MDR Text Key: 320124350
• Report Number: 2032493-2023-00869
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103500
• UDI-Public: (01)00842429103500(11)220406(17)250331(10)0000174918
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2024

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: LEV3517-MVE
• Device Lot Number: 0000174918
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2023
• Supplement Dates Manufacturer Received: 12/27/2023; 12/27/2023
• Supplement Dates FDA Received: 01/06/2024; 01/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2023
• 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
• Treatment: HYDROSOFT 1.5X2; HYDROSOFT 1X2; HYDROSOFT 2X1; HYDROSOFT HELICAL COIL
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Sex: Female