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

Model Number	W2-11-9-MVI-3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Status Epilepticus (4408); Swelling/ Edema (4577)
Date of Event	10/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent treatment using a web device back in (b)(6) 2023, and arrived at the emergency room with a seizure.An mri was performed, and it showed edema around the web device.The physician stated that the patient was prescribed steroids and is scheduled for a follow up mri angiogram in 30 days.The patient is at home and has not experienced another seizure since the initial episode.
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, imaging was provided.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Two radiographic images were provided for review.They show a metallic artifact caused by the web device in the left temporal lobe; furthermore, there is an area of white matter hyperintensity surrounding the aneurysm in the web, representing the edema described in the reported event.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
Additional information was obtained from the physician stating that the patient has been placed on comfort care.

• Brand Name: WEB SL
• 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: 23564224
• Report Number: 2032493-2025-90655
• Device Sequence Number: 9646433
• Product Code: OPR
• UDI-Device Identifier: 00842429107331
• UDI-Public: (01)00842429107331(11)191002(17)240930(10)19100209M
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/02/2025

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: 09/30/2024
• Device Model Number: W2-11-9-MVI-3
• Device Lot Number: 19100209M
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/15/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2019
• 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 Sex: Female