MAUDE Adverse Event Report: MICROVENTION INC. SOFIA 88 DAC; ISCHEMIC STROKE

Model Number	DA8115ST-DAC-US
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)
Date of Event	04/28/2025
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 discarded at the user facility and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.The alleged product issue could not be confirmed.If additional information is received at a later date, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the physician used the sofia 88 for a stroke patient that had an ica terminus occlusion.The physician placed the sofia 88 at the distal ica terminus and proceeded to aspirate.The sofia moved forward into the middle cerebral artery during aspiration.After the initial pass, an angiogram was performed and the occlusion was cleared but showed irregularity of the mca.The middle cerebral artery received injury while the sofia 88 was aspirating.No further testing other than the angiographic images done post thrombectomy.The physician provided heparin.The patient condition and outcome was reported to be good.
Event or Problem Description
It was reported that the physician used the sofia 88 for a stroke patient that had an ica terminus occlusion.The physician placed the sofia 88 at the distal ica terminus and proceeded to aspirate.The sofia moved forward into the middle cerebral artery during aspiration.After the initial pass, an angiogram was performed and the occlusion was cleared but showed irregularity of the mca.The middle cerebral artery received injury while the sofia 88 was aspirating.No further testing other than the angiographic images done post thrombectomy.The physician provided heparin.The patient condition and outcome was reported to be good.Additional information received indicated that no further testing done other than the angiographic images done post thrombectomy and the physician gave heparin.Please see h6 & h11.
Additional Manufacturer Narrative
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.

• Brand Name: SOFIA 88 DAC
• Common Device Name: ISCHEMIC STROKE
• 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: 22103169
• Report Number: 2032493-2025-90190
• Device Sequence Number: 17961057
• Product Code: QJP
• UDI-Device Identifier: 00842429117705
• UDI-Public: (01)00842429117705(11)240809(17)250731(10)0000668299
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K214024
• 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): 07/02/2025

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: 07/31/2025
• Device Model Number: DA8115ST-DAC-US
• Device Lot Number: 0000668299
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2024
• 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
• Patient Sex: Unknown