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

Model Number UNKNOWN

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

Patient Problem Aneurysm (1708)

Event Type  Injury  

Manufacturer Narrative

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.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.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, following is taken from the english version potential complications possible complications include but are not limited to the following: hematoma at the puncture site perforation or dissection of the vessel 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 1.Gain vascular access according to standard practice.2.Place guide catheter in the appropriate target vessel.3.Navigate the microcatheter.021 inch id microvention headway 21 microcatheter over a guide wire at least 15 mm distal to the aneurysm neck or target location.4.Remove the guide wire.5.Maintain flush through the microcatheter per standard endovascular practice.6.Select an appropriate sized lvis device.7.Carefully inspect the lvis device package for damage to the sterile barrier.8.Peel open the pouch using aseptic technique.9.Carefully place the dispenser coil into the sterile field.10a.Unclip the molded cap attached to the delivery wire from the dispenser coil.Pull on the 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.10b.After removal from the dispenser coil, carefully push on the delivery wire and in a bowl of saline, partially deploy the lvis implant up to 5 mm or 50 percent whichever occurs first, being careful not to detach the implant from the distal introducer tip.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.C.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.11.Confirm that the tip of the delivery wire is entirely within the introducer.12.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.13.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.14.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: the introducer must be properly engaged with the microcatheter hub to enable lvis device introduction into the microcatheter.15.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.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.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.17.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.18.Position the lvis device for deployment by aligning the lvis implant distal radiopaque end markers approximately 7 mm 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 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.19.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 percent deployed.Caution if resistance is felt while recapturing the lvis device, do not continue to recapture the device.Withdraw the microcatheter slightly to un-sheath 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.19.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 percent deployed.Caution if resistance is felt while recapturing the lvis device, do not continue to recapture the device.Withdraw the microcatheter slightly to un-sheath 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.20.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 percent from its undeployed length 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.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.21.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 guide wire.Do not torque the lvis device.A torque device should not be used.22.If applicable, remove the.021 inch microcatheter and advance a.017 inch inner diameter or suitable size microcatheter over the guide wire.23.Use the guide wire and microcatheter to access the aneurysm through the lvis device cells.Warning observe lvis device marker position during placement of the microcatheter into the aneurysm to ensure that the lvis device does not migrate or dislodge from its deployed position.24.After the microcatheter is positioned within the aneurysm, detachable coils may be delivered into the aneurysm according to conventional methods.25.After placing the last coil, verify that the lvis device has remained patent and properly positioned.Advance a guide wire to the microcatheter tip and carefully remove the microcatheter through the lvis device cells.Note a microcatheter may be positioned into the aneurysm sac prior to delivery of the lvis device.The microcatheter will be supported by the lvis device during delivery of embolic coiling.After completing the coiling, the microcatheter should be carefully removed to avoid dislodging the lvis device.26.After completing the procedure, withdraw and discard all applicable accessory devices.Zhu, deyuan, et al.Treatment of intracranial bifurcation aneurysms with x stent assisted coiling: a case series and literature review.Journal of stroke and cerebrovascular diseases 32.2 2023 106946.

Event Description

As reported through the journal article titled treatment of intracranial bifurcation aneurysms with x stent assisted coiling a case series and literature review, the patient underwent an endovascular procedure with an lvis stent for the treatment of their intracranial bifurcation aneurysm acom aneurysm with a diameter 5.2mm x neck 4.8mm x dome/neck 1.1.No procedural-related complications were noted; however, immediate angiographic results revealed a residual aneurysm.A follow up angiogram performed at 9 months revealed the patient's aneurysm had improved.A clinical follow up performed at 36 months, revealed an mrs score of zero.

Event Description

Please see medical data review conclusion in h10.

Manufacturer Narrative

Article review: medical data review: a detailed medical review of data has been completed.Review of journal article titled treatment of intracranial bifurcation aneurysms with x stent assisted coiling: a case series and literature review, provided evidence of a patient that patient that underwent an endovascular procedure with an lvis stent for the treatment of their intracranial bifurcation aneurysm acoma with a diameter 5.2mm x neck 4.8mm x dome neck 1.1.Patient received systemic intravenous heparin at the beginning of the procedure to achieve an activated clotting time of 250-300s during the procedure.The patient was maintained on antiplatelet therapy consisting of 75 mg clopidogrel for at least six weeks and 100 mg aspirin indefinitely.Immediate angiographic results revealed a residual aneurysm.Performance of a follow-up angiogram performed at 9 months revealed the patient¿s aneurysm had improved.Data indicates that no procedural-related complications were noted.Clinical follow-up performed at 36 months, revealed an mrs score of zero.No evidence device of device malfunction was reported.Medical data review conclusion.A detailed medical review of data has been completed.Medical data review conclusion indicates that a patient that patient that underwent an endovascular procedure with an lvis stent for the treatment of their intracranial bifurcation aneurysm acoma with a diameter 5.2mm x neck 4.8mm x dome neck 1.1.Data indicates that no procedural-related complications were noted.Clinical follow-up performed at 36 months, revealed an mrs score of zero.No evidence device of device malfunction was reported.

• Brand Name: LVIS D
• 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: 16153644
• MDR Text Key: 307261238
• Report Number: 2032493-2023-00527
• 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: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Male