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

Model Number 212517

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

Patient Problems Muscle Weakness (1967); Transient Ischemic Attack (2109); Visual Disturbances (2140); Stenosis (2263); Confusion/ Disorientation (2553)

Event Date 03/25/2021

Event Type  Injury  

Manufacturer Narrative

D4: information received noted a lvis partial model number (212517-lvis), and lot number is not known at this time.H10: the exact device model and lot number were not provided; therefore, a search for production-related non-conformances could not be performed.The device was implanted in the patient and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.The in-stent stenosis event as described could not be confirmed.H3 other text : device remains implanted.

Event Description

As reported through the clinical study: (b)(4): the patient presented to emergency dept.On (b)(6) 2021 with intermittent confusion and aphasia.Patient had right-sided weakness, right homonymous hemianopsia, sensory deficit and difficulty with repeating and naming things.Patient was able to follow commands but not oriented to month or age.Patient reported blurry vision 2 days prior.Exam was fluctuant locally, but nih stroke scale went as high as 15.Patient admitted after initial imaging showed that the cerebral vessels appeared open.Mri showed no acute stroke.Eeg was negative for seizures.Infectious work-up was negative.Patient noted recent bp medication change and had some low blood pressures, thought to be a possible etiology.Patient¿s exams gradually improved during admission, resolved without sequelae.Patient was discharged on (b)(6) 2021.After adjudication by clinical site, the incident was noted as; "in-stent stenosis (transient neurological deficit)¿, ipsilateral to target lesion, with hospitalization.It is noted "fluctuating deficits likely related to delayed in-stent stenosis".

Event Description

No additional information provided, please see h6 and h10.

Manufacturer Narrative

Procedure note medical review: a detailed procedure note medical review has been performed for complaint (b)(4).Data review indicates patient underwent treatment for defined pre-operative diagnosis of cerebral aneurysm.Surgical treatment included embolization of residual mca aneurysm and stenting assisted coiling of l mca on ((b)(6) 2017).Patient was last seen by post-operative physician on (b)(6) 2020 and was determined to be stable with (residual right homonymous hemianopsia and decreased sensation on the right side).Data review indicates that the procedure was completed with no reported intraoperative complications.On ((b)(6) 2023) patient was reported as being admitted for diagnosis transient anatomical right-side weakness.Acquisition of inpatient imaging showed that the cerebral vessels appeared open (with possible in stent stenosis).Mri showed now acute stroke.The patient noted that she recently changed her bp medication and had some low blood pressures so perhaps this was a possible etiology.Procedure note medical review conclusion - a detailed procedure note medical review has been completed for complaint (b)(4).A review of procedure note data indicates that no device associated malfunction was reported to be associated with the etiology of the reported adverse event (transient right-side weakness).Post surgical angiogram ((b)(6) 2023) indicates that there is in-stent stenosis of the left m1 mca, however flow in the left mca branches are visualized.Data review further indicates that the reported in-stent stenosis was not reported as contributory to the transient right-side weakness with history and physician examination data indicating patient reported blood pressure medication change identified as possible etiology of the reported adverse event.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.Procedure and medical imaging was not provided for this investigation.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.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of 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 could not be performed as this information was not available at the time this investigation was performed.Complaint system review: a search of the complaint handling system could not be performed to determine if other similar complaints exist for this batch number, because the batch number was not provided for the product on this complaint file.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.Directions for use: 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.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.Note: fluoroscopy may be used up to this point at the physician¿s discretion.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.Track the lvis device through the microcatheter to the tip.Carefully advance the lvis device until the device exit marker on the proximal end of the delivery wire approaches the rhv on the hub of the microcatheter.At this time, fluoroscopic guidance must be initiated.Position the lvis device for deployment by aligning the lvis implant distal radiopaque end markers approximately 7 mm past the aneurysm neck.[figure 6] 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.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 80% deployed).[figure 7] 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 guide wire.Do not torque the lvis device.A torque device should not be used.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).[figure 7] 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 guide wire.Do not torque the lvis device.A torque device should not be used.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 60% from its undeployed length (refer to tables 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 on each side of the aneurysm neck or target location to ensure appropriate neck coverage.[figure 8] 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.A detailed procedure note medical review has been completed for complaint.A review of procedure note data indicates that no device associated malfunction was reported to be associated with the etiology of the reported adverse event (transient right-side weakness).Post surgical angiogram (3-25-2023) indicates that there is in-stent stenosis of the left m1 mca, however flow in the left mca branches are visualized.Data review further indicates that the reported in-stent stenosis was not reported as contributory to the transient right-side weakness with history and physician examination data indicating patient reported blood pressure medication change identified as possible etiology of the reported adverse event.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.

• Brand Name: LVIS D
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• 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: 17398109
• MDR Text Key: 319839056
• Report Number: 2032493-2023-00864
• Device Sequence Number: 1
• Product Code: QCA
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

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: 212517
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization