MAUDE Adverse Event Report: MICROVENTION, INC. SOFIA FLOW PLUS 6F; CATHETER, THROMBUS RETRIEVER

Model Number	DA6131ST-ASP-US-OD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation conclusion: the physical device was not available for evaluation to investigate if a condition existed that would have contributed to 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
It was reported through the restore clinical trial, a stent retriever passed with a lot of traction on vessel resulted in intracranial hemorrhage (ih type 2).Reportedly, decompressive hemicraniectomy intervention was performed.The adverse event resolved on (b)(6) 2024 with sequelae nihss = 7.Event described as related to concurrent condition/treatment specified as stroke.Severity indicated as moderate.The event was adjudicated by clinical review committee (ces) as sah not hi2.Event assessed as possibly related to sofia device; not related to eric or bobby devices; definitely related to thrombectomy procedure; possibly related to study disease and concurrent condition/treatment.The patient had clinic visit on (b)(6) 2024 for 90-day follow-up.Patient was living in a nursing home.Neuro evaluation was nihss of 7; mrs was 3.The patient exited study on (b)(6) 2024.

• Brand Name: SOFIA FLOW PLUS 6F
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enerprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 21670750
• Report Number: 2032493-2025-00245
• Device Sequence Number: 8164900
• Product Code: NRY
• UDI-Device Identifier: 00810170019234
• UDI-Public: (01)00810170019234(11)240612(17)270531(10)0000625069
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2025

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 Model Number: DA6131ST-ASP-US-OD
• Device Lot Number: 0000625069
• 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: 03/06/2025
• Initial Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BOBBY BALLOON GUIDE CATHETER (MICROVENTION).; ERIC RETRIEVAL DEVICE (MICROVENTION).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown