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

Model Number 172020-LVISJ-C-PMA

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

Patient Problem Perforation of Vessels (2135)

Event Date 11/03/2022

Event Type  Death  

Event Description

It was reported during treatment of an aneurysm rupture, a web was placed into a wide neck aneurysm.Upon deployment of the web, the aneurysm started to bleed.A scepter balloon was used to control the bleeding.Then an lvis jr.Was used to assist the web further into the aneurysm.A coronary balloon was used to post process the stent to oppose wall better.The physician is not blaming the product for any of the issues.The device was implanted in the patient.The patient underwent a craniotomy later the same day.Additional information was received, stated that the physician used the coronary balloon device to manipulate the lvis jr.In order to create a more flawless wall opposition.The wire from the coronary balloon device subsequently perforated the pericallosal region.The patient then underwent a hemi craniotomy and later expired.

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 was implanted in the patient and not returned to the manufacturer for evaluation.Images and operative report were not provided at the time of reporting.The investigation is currently ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.The first device used in the same procedure being reported, a web intrasaccular device that was also implanted, was previously reported under mdr 2032493-2022-00530.

Manufacturer Narrative

Procedure-note-medical review of operative report conclusion detailed operative report medical review has been completed for compliant (b)(4).Operative report summary data review indicates the occurrence of an intra-operative rupture of acom aneurysm during web embolization.Web deployed rapidly to address active extravasation.Lvis jr.Stent placed due to web impingement on right a2.Following stent deployment, there was question of whether it expanded fully around the curve and whether it fully opposed the vessel walls.Angiography performed after deployment of the lvis jr.Stent was concerning for the physician as some haziness and slow flow through the stent indicating potential thrombus was identified.Due to this concern, the physician sought to go back through the stent with the 3 max aspiration catheter navigated over a synchro microwire and aspirate to ensure there was no thrombus present.Physician had significant difficulty navigating the 3 max to this point and getting the microwire back through the stent.Intermittent angiography was performed and confirmed that there was still flow but it was slightly reduced in appearance so the physician changed tactics and felt that deploying an additional stent would ensure the lvis jr.Was open fully and potentially improve flow.Concern for inadequate flow through lvis jr.Prompted additional onyx stent deployment.During preparation of stent, microwire perforation of right pericallosal artery was noted and vessel coil embolized was performed.Operative data confirms physician concerns with navigating thru the lvis jr.Stent and after repeated failed attempts, physician switched to the chikai microwire.Patient was admitted to the neurocritical care unit and monitored closely.The scepter balloon was used to aid in flow arrest after rupture.The onyx resolute coronary stent mounted on balloon was through the lvis jr.And there was distal wire perforation from balloon mounted stent in the pericallosal region.A bleed occurred coils were used to shut down bleed.Additional data indicates that the physician was attempting to manipulate the lvis jr.And that is the reason for the use of the coronary device wire causing the perforation in the pericallosal region.The patient went to operating room and where a hemi craniotomy was performed.The patient is deceased.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 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): warnings do not use device for acutely ruptured intracranial aneurysms within a minimum of 30 days from intracranial aneurysm rupture.Should unusual resistance be felt at any time during access or removal, the introducer/microcatheter and lvis device should be removed as a single unit.Applying excessive force during delivery or retrieval of the lvis device can potentially result in loss or damage to the device and delivery components.The lvis device should only be used by physicians trained in endovascular interventional neuroradiology, radiology, neurosurgery or interventional neurology on the treatment of intracranial aneurysms.Selection of the lvis device size is important for proper product performance and patient safety and must be based on pre- treatment angiograms for correct and accurate vessel measurements from multiple views.It is imperative to use the lvis device with compatible microcatheters.If repeated friction is encountered during lvis 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 device in the parent vessel without fully retrieving the device.The lvis device must be retrieved into the microcatheter and re-deployed at the desired target location or removed completely from the patient.Do not attempt to re-position the lvis implant after detachment.Do not shape the tip of the delivery wire.Do not torque the delivery wire while advancing or retracting the lvis device.A torque device should not be used.Precautions the lvis device is provided sterile for single use only.Do not reuse, reprocess or resterilize.Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death.Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.Contamination of the device may lead to injury, illness or death of the patient.Carefully inspect the sterile package and the lvis device prior to use to verify that neither has been damaged during shipment.Do not use kinked or damaged components, or if the packaging is damaged.See the product label for the device shelf life.Do not use the device beyond the labeled use by date.Exercise caution when crossing the deployed/detached lvis device with adjunctive devices such as guidewires, catheters, microcatheters or balloon catheters to avoid disrupting the device geometry and device placement.The lvis and lvis jr.With neurovascular embolization coils may create local field inhomogeneity and susceptibility artifacts during magnetic resonance angiography mra, which may degrade the diagnostic quality to assess effective intracranial aneurysm treatment.The safety and effectiveness of the device has not been established in the treatment of large and giant wide neck intracranial aneurysms.The benefits may not outweigh the risks of treatment in patients with wide-neck intracranial aneurysms 5 mm in size, or reduced life expectancy, in the absence of additional risk factors for intracranial aneurysm rupture.The safety and effectiveness of the device has not been well established in the posterior circulation.Ensure that the specific embolization coil models and sizes used are indicated for the embolization of intracranial aneurysms.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.Potential risks associated with x-ray exposure: the use of the lvis device requires fluoroscopy, which presents potential risks associated with x-ray exposure.The risks of angiographic and fluoroscopic x-ray radiation doses to the patient include risks such as alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia that increase in probability as procedure time and number of procedures increase.The probability of adverse event occurrence increases as the procedure time and the number of procedures increase.Operators should take all necessary precautions to limit x-ray radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying x-ray technical factors whenever possible.

• Brand Name: LVIS JR.
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• 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: 16019823
• MDR Text Key: 305869074
• Report Number: 2032493-2022-00438
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

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: 172020-LVISJ-C-PMA
• Device Catalogue Number: 172020-LVISJ
• Device Lot Number: 0000215434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 12/28/2022
• Supplement Dates FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Sex: Female