MAUDE Adverse Event Report: MICROVENTION, INC. WEB SLS; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number	W2-9-4-MVI-3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to the manufacturer for analysis as it remains within the patient; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.
Event or Problem Description
As reported through the web pas clinical study, event #3.Event term: web compaction, addition of stent and coil.No technical event reported.The relationship to the study device is reported as probable.Relationship to study disease is reported as possible.Ae outcome: recovered/resolved.Date of resolution: (b)(6) 2025.

• Brand Name: WEB SLS
• Common Device Name: INTRASACCULAR FLOW DISRUPTION 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: 22079668
• Report Number: 2032493-2025-90183
• Device Sequence Number: 21008175
• Product Code: OPR
• UDI-Device Identifier: 00842429107195
• UDI-Public: (01)00842429107195(11)210812(17)260731(10)0000063596
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: W2-9-4-MVI-3
• Device Lot Number: 0000063596
• 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: 05/13/2025
• Initial Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2021
• 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: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 80 KG