MAUDE Adverse Event Report: MICROVENTION INC. LVIS JR.; LOW-PROFILE VISUALIZED INTRALUMINAL SUPPORT DEVICE

Model Number MV-L251717

Device Problem Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2023

Event Type  malfunction  

Event Description

It was reported that when half of the stent was opened, an attempt was made to re-sheath the stent for repositioning, but the stent was not re-sheathed as it was difficult to manipulate in the microcatheter.The entire stent was slowly removed with the microcatheter from the patient.A competitor¿s product was used to complete the procedure.There was no reported injury or health damage to the patient.

Manufacturer Narrative

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.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.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, the following is taken from the english version): potential adverse events the following potential risks and complications associated with general anesthesia, cerebral angiography, intracranial catheterization, intracranial stent placement or intra-saccular coil deployment have been identified below: allergic reaction, including but not limited to: contrast dye, nitinol metal, and any other medications used during the procedure; aphasia; blindness; cardiac arrhythmia; coil prolapsed or migration into normal vessel adjacent to aneurysm; complications of arterial puncture including pain, local bleeding, local infection and injury to the artery, vein or adjacent nerves; cranial neuropathy; death; device fracture, migration or misplacement; dissection or perforation of the parent artery; headache; hemorrhage (i.E., intracerebral hemorrhage (ich), subarchnoid hemorrhage (sah), or retroperitoneal (or in other locations)); hemiplegia; hydrocephalus; infection; injury to normal vessel or tissue; ischemia; mass effect; myocardial infarction; neurological deficits; occlusion of non-target side branches; pseudo aneurysm formation;reactions to anti-platelet/anti-coagulant agents; reactions due to radiation exposure; reactions to anesthesia and related procedures; reactions to contrast agents; renal failure; aneurysm rupture; stenosis of stented segment; seizure; stent thrombosis; stroke or tia (transient ischemic attack); thromboembolic event (t/e); vasospasm; visual impairment.Directions for use gain vascular access according to standard practice.Place guide catheter in the appropriate target vessel.Navigate the corresponding microcatheter (.021¿ microvention headway® 21 microcatheter for lvis device /.017¿ microvention headway® 17 or scepter¿ c / scepter¿ xc occlusion balloon for lvis jr.Device) over a guidewire at least 15 mm distal to the aneurysm neck or target location.Remove the guidewire.Maintain flush through the microcatheter per standard endovascular practice.Select an appropriate sized lvis device (refer to table 1a/b).Carefully inspect the lvis device package for damage to the sterile barrier.Peel open the pouch using aseptic technique.Carefully place the dispenser coil into the sterile field.Unclip the molded cap attached to the delivery wire from the dispenser coil.Pull on proximal end of the delivery wire until the introducer exits the dispenser coil.Hold the delivery wire and introducer together while continuing to remove the entire device.Do not partially deploy the lvis device from the introducer.After removal from the dispenser coil, carefully push on the delivery wire in a bowl of saline, partially deploy the lvis implant up to 5 mm or 50% (whichever occurs first, being careful not to detach the implant) from the distal introducer tip (refer to table 1a/b and figure 3b).Check for the following: implant distal marker uniformity.Implant distal end shows even displacement with no entanglement.Implant tracks smoothly through introducer.Warning: do not fully deploy lvis device.If the device is deployed, do not attempt to reload the device.Use a new device.With the lvis implant and introducer sheath positioned and hydrated within the bowl of saline, gently manipulate the lvis implant within the saline to hydrate the implant and minimize visible air bubbles.Carefully pull back on the delivery wire to fully retrieve the lvis implant and the delivery wire tip within the introducer.Warning: do not continue if any defect is observed; return the unit to microvention, inc.1confirm that the tip of the delivery wire is entirely within the introducer.Confirm that the delivery wire is not kinked and that the introducer tip is not damaged.Do not continue if either defect is observed; return the unit to microvention, inc.Warning: do not shape the tip of the delivery wire.Partially insert the distal end of the introducer into the rhv connected to the microcatheter.Tighten the rhv locking ring.Flush the y-connector of the rhv with sterile saline and verify that fluid exits the proximal end of the introducer.Warning: purge the lvis device carefully to avoid the accidental introduction of air into the system.[figure 4] untighten the rhv locking ring and advance the introducer until it is fully engaged with the microcatheter hub, then tighten the rhv locking ring.Warning: confirm that there are no air bubbles trapped anywhere in the system.Caution: confirm that there is no gap between the introducer and the microcatheter hub to enable lvis device introduction into the microcatheter.[figure 5] 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, ensuring a sufficient length of stent will deployed on either side of the aneurysm neck, by aligning the lvis implant distal radiopaque end markers sufficiently 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 are 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 guidewire after stent deployment.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 sufficiently 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 table 1a/b) 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 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.Prior to removing the delivery wire and if necessary, carefully position the microcatheter distal to the lvis device to maintain access through the lvis device.Remove and discard the delivery wire.Warning: the lvis device delivery wire should not be utilized as a guidewire.Do not torque the lvis device.A torque device should not be used.Deploy coils per standard interventional techniques.Caution: use caution when positioning and withdrawing the microcatheter used for coil placement to ensure that the stent is not displaced.After placing the last coil, verify that the lvis device has remained patent and properly positioned.After completing the procedure, withdraw and discard all applicable accessory devices.

• Brand Name: LVIS JR.
• Type of Device: LOW-PROFILE VISUALIZED 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: 17052416
• MDR Text Key: 317002607
• Report Number: 2032493-2023-00765
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 04987350998477
• UDI-Public: (01)04987350998477(11)220524(17)250430(10)0000193001
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MV-L251717
• Device Lot Number: 0000193001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2023
• Initial Date FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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