MAUDE Adverse Event Report: MICROVENTION, INC. SOFIA-5F-115CM STR; CATHETER INTRAVASCULAR DIAGNOSTIC

Model Number	DA5125ST
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Hemorrhagic Stroke (4417); Embolism/Embolus (4438)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The device was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.The instructions for use (ifu) identifies thrombolytic occlusion as a potential complication associated with use of the device.
Event or Problem Description
As reported through the sofast clinical trial (event -002), the subject was taken to the angiography suite for mechanical thrombectomy for a right temporal m2 occlusion on (b)(6) 2023.After the initial pass, the occluded temporal m2 was open but residual occlusion of a superior/parietal branch remained.A second pass was made which opened up the m3 but there was a residual m4 occlusion.This was left alone per the operative note.Control angiography after the second pass showed delayed filling of a parietal wedge but reasonable retrograde filling.Independent reviewing committee cec and adjudicated as related possibly to device, definitely to procedure.Additional information indicated: no intervention was performed.The patient was successfully extubated.On evaluation the patient continues to have right gaze preference although neglect seems slightly improved.Still with left facial droop and right hemiparesis.New information indicated: event -004: subarachnoid hemorrhage.Event date: (b)(6) 2024 a post-thrombectomy ct done on (b)(6) 2023 showed a subarachnoid hemorrhage.Follow-up cts done on (b)(6) 2023 and 02dec2023 showed unchanged subarachnoid hemorrhage and no new hemorrhage.No other follow-up imaging was ordered.Resolved without sequelae.Independent reviewing committee cec and adjudicated as possibly related to the sofia, definitely related to the procedure.
Event or Problem Description
A follow-up report is being submitted to make correction to the date within the event description.Subarachnoid hemorrhage.Event date: 30nov2023.A post-thrombectomy ct done on (b)(6) 2023 showed a subarachnoid hemorrhage.Follow-up cts done on (b)(6) 2023 and(b)(6) 2023 showed unchanged subarachnoid hemorrhage and no new hemorrhage.No other follow-up imaging was ordered.
Additional Manufacturer Narrative
Date correction was made in section b5.

• Brand Name: SOFIA-5F-115CM STR
• Common Device Name: CATHETER INTRAVASCULAR DIAGNOSTIC
• 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: 19630237
• Report Number: 2032493-2024-00506
• Device Sequence Number: 8673120
• Product Code: DQO
• UDI-Device Identifier: 00810170019234
• UDI-Public: (01)00810170019234(11)230929(17)260831(10)0000430841
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K142014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: 08/31/2026
• Device Model Number: DA5125ST
• Device Lot Number: 0000430841
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2023
• 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
• Patient Age: 83 YR
• Patient Sex: Female