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

Model Number 172020-CASJ-C-CN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/22/2023

Event Type  malfunction  

Manufacturer Narrative

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.The device remains implanted in the patient and not returned to the manufacturer for evaluation.Procedural notes were not provided; however, medical imaging was received.The alleged product issue could not be confirmed at this time.However, the investigation is ongoing.Upon completion, of the investigation, a supplemental report will be submitted.

Event Description

It was reported that after the stent was released, while retrieving the guide wire of the stent.It was observed that the head end of the guide wire was broken in the blood vessel.Immediate angiography imaging revealed that the broken portion was attached to the blood vessel wall and did not float in the vessel.There was no patient harm reported and the patient is stable.

Manufacturer Narrative

Additional information was received containing one radiographic image is provided.Radiographic image is submitted.It is a single-shot unsubtracted radiograph with no contrast.It is an ap projected, cropped, and centered over the right lateral upper orbit.There is a mostly vertically positioned lvis stent with a mild curve at its proximal third.A small ball of coils is centered over the stent's mid-portion.The straight tail of a radiopaque wire or coil extends from the coil ball to the proximal ¼ of the stent.This image does not contribute to what caused the complaint.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.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): please refer to the chinese ifu for precautions, warnings, and further information.The 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(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 jr.Device should be removed as a single unit.Applying excessive force during delivery or retrieval of the lvis jr.Device can potentially result in loss or damage to the device and delivery components.It is imperative to use the lvis jr.Device with compatible microcatheters.If repeated friction is encountered during lvis jr.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 jr.Device in the parent vessel without fully retrieving the device.The lvis jr.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 jr.Device with adjunctive devices such as guidewires, catheters, microcatheters or balloon catheters to avoid disrupting the device geometry and device placement.Directions for use advance the delivery wire to transfer the lvis jr.Device from within the introducer into the microcatheter.Warning: do not torque the delivery wire while advancing or retracting the lvis jr.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.Warning: do not apply undue force.If resistance is encountered at any point during lvis jr.Device delivery or manipulation, withdraw the unit and select a new lvis jr.Device.Position the lvis jr.Device for deployment by aligning the lvis jr.Implant distal 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 jr.Device to achieve full expansion and good vessel apposition.Note: slowly advancing the lvis jr.Device while adjusting the microcatheter position will ensure accurate deployment.Maintain simultaneous control of the lvis jr.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 jr.Device is not recommended and may result in device elongation.If lvis jr.Device positioning is not satisfactory, the lvis jr.Device may be recaptured and repositioned if it is not fully deployed.The lvis jr.Device may be recaptured until the point where the proximal end of the lvis jr.Device markers is aligned 3 mm proximally with the microcatheter distal marker band (approximately 75% deployed).Caution: if resistance is felt while recapturing the lvis jr.Device, do not continue to recapture the device.Withdraw the microcatheter slightly to unsheath the lvis jr.Device (without exceeding the recapture limit), and then attempt to recapture the lvis jr.Device.Caution: the lvis jr.Device must not be re-deployed more than three times.Note: the lvis jr.Device delivery wire should not be utilized as a guidewire.Do not torque the lvis jr.Device.A torque device should not be used.If lvis jr.Device positioning is satisfactory, carefully retract the microcatheter and advance the delivery wire together, to allow the lvis jr.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 jr.Device will expand and total length may foreshorten up to 35% 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 jr.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 jr.Device to maintain access through the lvis jr.Device.Remove and discard the delivery wire.Warning: the lvis jr.Delivery wire should not be used as a guidewire.Do not torque the lvis jr.Device.A torque device should not be used.Use the guidewire and microcatheter to access the aneurysm through the lvis jr.Device cells.Warning: observe lvis jr.Device marker position during placement of the microcatheter into the aneurysm to ensure that the lvis jr.Device does not migrate or dislodge from its deployed position.After the microcatheter is positioned within the aneurysm, detachable coils may be delivered into the aneurysm according to conventional methods.Warning: observe lvis jr.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 jr.Device has remained patent and properly positioned.Advance a guidewire to the microcatheter tip and carefully remove the microcatheter through the lvis jr.Device cells.Note: a microcatheter may be positioned into the aneurysm sac prior to delivery of the lvis jr.Device.The microcatheter will be supported by the lvis jr.Device during delivery of embolic coiling.After completing the coiling, the microcatheter should be carefully removed to avoid dislodging the lvis jr.Device.Caution: carefully watch the lvis jr.Device distal and proximal markers when passing through the deployed lvis jr.Device with embolic coiling microcatheters to avoid displacing the lvis jr.Device.Investigation conclusion one procedure image was provided for review.It is a single-shot unsubtracted radiograph with no contrast.It is an ap projected, cropped, and centered over the right lateral upper orbit.There is a mostly vertically positioned lvis stent with a mild curve at its proximal third.A small ball of coils is centered over the stent's mid-portion.The straight tail of a radiopaque wire or coil extends from the coil ball to the proximal ¼ of the stent.Based on the event description, the wire or coil tail seen on the image fractured and separated from the pusher while the pusher was being pulled back.It did not unravel, as there is a clean end to the radiopaque tail.However, this image does not describe what caused the complaint.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.

Event Description

See h10 for radiographic image review.

• Brand Name: LVIS JR.
• Type of Device: INTRALUMINAL DEVICES
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 17458067
• MDR Text Key: 320499719
• Report Number: 2032493-2023-00880
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103319
• UDI-Public: (01)00842429103319(11)220308(17)250228(10)0000164254
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

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: 172020-CASJ-C-CN
• Device Lot Number: 0000164254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/04/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• 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