MAUDE Adverse Event Report: MICROVENTION, INC. LVIS EVO; INTRACRANIAL COIL-ASSIST STENT

Model Number	LEV3018
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Paresis (1998); Hydrocephalus (3272); Ruptured Aneurysm (4436)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Additional 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.Ongoing attempts are being made for the device return.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Event or Problem Description
As reported: four days prior to the event, patient was admitted for evaluation of sudden onset of dizziness and nausea/vomiting.Per chart review, patient stated that her dizziness worsened with position changes and stated the room felt like it was spinning.Laboratory findings were relatively unremarkable.Chest x-ray along with ct abdomen/pelvis did not show any acute etiologies for nausea/vomiting.A brain mri was obtained that demonstrated an unruptured 7 mm saccular anterior communicating artery aneurysm.Two days after admission, patient underwent balloon assisted coiling of acom aneurysm.Post op, patient was admitted to the icu for close neurological monitoring/continuation of cares.Two days after balloon assisted coiling, patient underwent stent assisted coiling given small residual acom aneurysm at lobulated base.Unfortunately, patient had intraoperative rupture at the base after stent deployment that was controlled with additional coiling.Small m4 distal occlusion self resolved.Ct demonstrated sah with small ivh, no hydrocephalus.No signs of hypoperfusion on dsa.Post op, patient was extubated and noted to have right hemiparesis.Stat head cta demonstrated new sah with contrast, ivh and mild supratentorial hydrocephalus.Patient was admitted back to icu.The next day, patient was successfully extubated.Four days after patient was extubated, interval worsening of left mca hemorrhagic transformation with increased midline shift, and patient was put on medication.The day after, patient was febrile and bilateral lower extremity venous ultrasound demonstrated a right peroneal dvt.Four days later, still on medication, patient was hemodynamically stable, oxygenating well on room air, no acute events overnight, with follow-up head ct completed.This report is for the stent that was deployed prior to the aneurysm rupture.
Additional Manufacturer Narrative
The physical device was not available for evaluation to investigate if a condition existed that would have contributed to the reported event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation further examine the cause of the reported event.This information may be updated if additional information is provided at a later date.
Event or Problem Description
Additional information received: regarding the stent used, per the staff, lvis got stuck in stent & catheter.Lvis was implanted.

• Brand Name: LVIS EVO
• Common Device Name: INTRACRANIAL COIL-ASSIST STENT
• 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: 22120095
• Report Number: 2032493-2025-90204
• Device Sequence Number: 4251716
• Product Code: QCA
• UDI-Device Identifier: 00842429117781
• UDI-Public: (01)00842429117781(11)231117(17)261031(10)0000459486
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P170013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: LEV3018
• Device Lot Number: 0000459486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 111 KG