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

Model Number	LEV3018
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	03/01/2026
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.The device was implanted and therefore not available for return and investigation by the manufacturer.However, medical information was provided and will be reviewed.The investigation is ongoing and upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
As reported: stent was placed with difficulty, however, post implantation angios showed a successful procedure.Later, small strands were noted on ct.Physician assumes that these strands were from a part of the stent that had broken off.Patient had a stroke but has subsequently recovered aside from some lingering arm numbness.No intervention was performed on the stroke nor is one planned.The patient has mostly improved now.Physician attributes the stroke to the overall difficulty of the case, not to the lvis evo.Physician had to do significant manipulation of the catheter and wire to get access and the placement was tough, so he thinks that caused the stroke.
Additional Manufacturer Narrative
The implanted date in section d has been updated.A detailed medical review of the provided procedure note revealed that the patient underwent stent assisted coil embolization of an unruptured right middle cerebral artery aneurysm utilizing an lvis evo device.As the reported event occurred post-procedure, it is not recorded in the provided procedure note.The two provided radiographic videos show a coil mass and stent in the proximal mca.A small metallic fragment is seen in an m2 or m3 branch and another in a distal right mca branch, which is consistent with the fragment described in the reported event.However, the investigation could not determine if the fragments observed are part of the stent device.Without the return and physical evaluation of the device, the investigation cannot further examine if a condition existed that would have contributed to the reported event.
Event or Problem Description
No additional information received regarding the event.

• 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: 24694029
• Report Number: 2032493-2026-00190
• Device Sequence Number: 10463346
• Product Code: QCA
• UDI-Device Identifier: 00842429117781
• UDI-Public: (01)00842429117781(11)240910(17)270831(10)0000696166
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P170013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 03/27/2026

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: 0000696166
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Female