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 Codes	Intracranial Hemorrhage (1891); Muscle Weakness/Atrophy (1967); Obstruction/Occlusion (2422); Speech Disorder (4415); Facial Paralysis (4585)
Date of Event	12/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported through the restore clinical trial, the patient presented to the hospital with right sided facial droop, right sided hemiparesis, and worsening expressive aphasia.The patient was treated with a mechanical thrombectomy and was discharged to home self-care three days post procedure.At that time nihss was six, notable for disorientation, slight facial droop, severe aphasia, and mild dysarthria.Shortly after patient returned home the spouse noted right sided weakness, increased global aphasia, and increased facial droop.The patient presented back to the emergency department on (b)(6) 2024.Cta performed demonstrating distal left m1 occlusion.Neuro contacted and another cta performed showing distal left mca m1 occlusion with a 6ml core and 80ml penumbra.Lytic not administered due to being out of window.Decision made to proceed to another mechanical thrombectomy for treatment.Ir-cerebral angiogram performed by the physician start time on (b)(6) 2024.Combined mechanical thrombectomy performed with a final mtici score of 2b.This was complicated by an anterior m2-3 contrast extravasation/subarachnoid hemorrhage requiring coil embolization of anterior branch of left m2.Event resolved with sequelae and assessed as possibly related to the sofia device, mechanical thrombectomy procedure and concurrent condition/treatment, and definitely to the study disease.Patient admitted to the hospital on (b)(6) 2024 and discharged on (b)(6) 2024.
Additional Manufacturer Narrative
Investigation conclusion: the physical device was not available for evaluation to investigate if a condition existed that would have contributed to the reported 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.

• Brand Name: SOFIA FLOW PLUS 6F
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• 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: 22116391
• Report Number: 2032493-2025-90196
• Device Sequence Number: 11805138
• Product Code: NRY
• UDI-Device Identifier: 00842429108482
• UDI-Public: (01)00842429108482(11)240805(17)270731(10)0000667112
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 05/30/2025

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: 07/31/2017
• Device Model Number: DA6131ST-ASP-US-OD
• Device Lot Number: 0000667112
• 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: 05/15/2025
• Initial Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female