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

Model Number MV-L451821

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

Patient Problems Cyst(s) (1800); Paresis (1998); Pneumonia (2011); Meningitis (2389)

Event Date 08/16/2021

Event Type  Death  

Event Description

It was reported during a conference that a patient expired 20 months post implantation of an lvis stent.The patient was initially treated on (b)(6) 2021 for an unruptured aneurysm of the right vertebral artery.The aneurysm was wide in diameter, and the lower part of the aneurysm was buried in the pons.Stent-assisted coil embolization was performed for the aneurysm.The lvis stent was implanted in the parent vessel for coil embolization.Six months post procedure, cerebral angiography showed no recurrence of the aneurysm.Eight months post procedure, an mri revealed a danger signal on flair image around the aneurysm.Oral administration of steroid was started, but the finding gradually progressed, and 20 months after the procedure, mri showed cyst formation around the aneurysm.After that, the patient developed right hemiparesis, which progressed with the temporary enlargement of the cyst.As the patient developed left abducens nerve palsy and dysarthria of swallowing, cyst fenestration was performed after parent artery coil embolization of the vertebral artery was performed.The cyst was partially fenestrated, and the coil was removed, which resulted in reduction in cyst size, but the patient developed aspiration pneumonia and bacterial meningitis due to dysphagia after the procedure.The patient¿s condition did not recover, which led to the patient's death.No autopsy was performed.The physician believes that there is no causal relationship between the lvis stent and the patient death.

Manufacturer Narrative

The device was implanted in the patient and not returned to the manufacturer for evaluation.Procedural images and op notes were requested and not yet received to date.The investigation is currently ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

Manufacturer Narrative

Procedure note assessment.Medical assessment review of procedure note.A detailed medical assessment review of available procedure note data has been completed.A review of available data indicates that a 63-year-old female was found to have an unruptured aneurysm of the right vertebral artery on head mri and mra.Diameter of the aneurysm was determined to be with a dome of 8.7 mm and a neck of 9.0 mm, lower part of the aneurysm was buried in the pons.Data reflects that stent-assisted coil embolization was performed for the aneurysm.An lvis stent 4.5 mm x 18 mm was then deployed and implanted in the parent vessel for coil embolization.Six months post performance of the procedure, a cerebral angiogram was performed which showed no recurrence of the aneurysm, but after 8 months, the performance of an mri revealed a danger signal on flair image around the aneurysm.The patient received oral administration of steroid, but the finding gradually progressed, and 20 months after the procedure, an mri showed cyst formation around the aneurysm.The data upon review indicates that after performance of the diagnostic mri, the patient developed right hemiparesis no date provided for the development of the hemiparesis which progressed with the temporary enlargement of the cyst.As the patient developed left abducens nerve palsy and dysarthria of swallowing, cyst fenestration was performed after parent artery embolization using coils was performed on the vertebral artery.Visual assessment of the cyst provide evidence that the cyst was partially fenestrated, and the coil was removed, which resulted in reduction in cyst size.The patient developed aspiration pneumonia and bacterial meningitis due to dysphagia after the procedure, and the patient¿s condition did not recover, which led to the patient's death.No autopsy was performed.The device is implanted and will not be returned.The physician indicated that he believes that there is no causal relationship between the lvis stent and death.Although there is a possibility that aneurysms that contact the brain parenchyma may cause inflammation and cyst formation in the brain parenchyma due to the beating of the aneurysm, especially one that coiled and hardened inside the aneurysm, a causal relationship to the device cannot be 100 percent ruled out.Medical review assessment conclusion of procedure notes a detailed medical assessment review of available procedure note data has been completed.The device is not available for return as it is still implanted within the patient who is deceased, and no autopsy was performed.There are no images available for evaluation.Assessment of the available data indicates that the patient developed aspiration pneumonia and bacterial meningitis due to dysphagia after the procedure, and the patient¿s condition did not recover, which led to the patient's death.This was not confirmed as no autopsy was performed.The physician indicated that he believes that there is no causal relationship between the lvis stent and death.The procedure notes to include the physician causal relationship declarative statement data do not reflect an association of the device deployment use and the subsequent death of the patient.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.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 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 potential complications possible complications include but are not limited to the following hematoma at the puncture site perforation or dissection of the vessels 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.

Event Description

Please refer to h10 for conclusion.

• 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: 15997065
• MDR Text Key: 305633050
• Report Number: 2032493-2022-00553
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 04987892041471
• UDI-Public: (01)04987892041471(11)200326(17)230228(10)20032655B
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

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 Expiration Date: 02/28/2023
• Device Model Number: MV-L451821
• Device Lot Number: 20032655B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2020
• 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): Death
• Patient Age: 63 YR
• Patient Sex: Female