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

Model Number	W5-5-S-MVI-3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Transient Ischemic Attack (2109); Numbness (2415)
Date of Event	10/11/2023
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 in the patient and was not available for return to the manufacturer.The event as described could not be confirmed.The instructions for use (ifu) identifies transient ischemic attack as a potential complication associated with use of the device.
Event or Problem Description
It was reported through the web pas clinical trial that a patient who was treated with a web device experienced a suspected transient ischemic attack 286 days post procedure and left sided weakness 293 days post procedure.The patient presented to ed with acute onset of left sided numbness and weakness on day 286 post procedure.The patient¿s left side had become flaccid at work with no sensation.Their symptoms resolved en route to ed with ems.They were given 60mg effient loading dose with 10mg maintenance.The patient did not take the medication due to the cost.Then, 293 days post procedure, the patient experienced sudden onset of left-sided weakness that resolved by the time ems arrived.Mri done 10/23 revealed no evidence of stroke.The patient was prescribed plavix.The outcomes of the events is considered to be ¿recovered/resolved.¿.

• Brand Name: WEB
• 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: 21126890
• Report Number: 2032493-2025-00052
• Device Sequence Number: 7583476
• Product Code: OPR
• UDI-Device Identifier: 00842429110874
• UDI-Public: 00842429110874
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 01/10/2025

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: 02/29/2024
• Device Model Number: W5-5-S-MVI-3
• Device Lot Number: 210305123
• 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: 12/17/2024
• Initial Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2021
• 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: Other; Required Intervention
• Patient Sex: Unknown