MAUDE Adverse Event Report: MICROVENTION, INC. SOFIA FLOW 5F; ISCHEMIC STROKE

Model Number DA5125ST-E

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 02/25/2024

Event Type  Injury  

Event Description

It was reported that the physician was treating a stroke on the right media artery.An aspiration catheter was placed on the proximal thrombus inside the right media artery.A first trial of aspiration was not sufficient.The decision for thrombectomy using a stentriever and microcatheter was made.After the first pass, a positive effect on the media artery was shown.At the same time a thrombus formation at the carotid t was noticed.During the preparation for the second pass, physician noticed a wire coming out of the distal tip of the catheter.The catheter was exchanged to another catheter and the examination continued.When the catheter was advanced physician found an ongoing thrombus formation on the carotid t.The media artery was occluded.The physician had the impression that some material was sheared off from the tip of the previous catheter.It was the physician's opinion that this material was the root cause for the complete occlusion of the carotid t.Several trials of thrombectomy were performed to remove the material and thrombus from the carotid t and media artery.All trials were unsuccessful; the arteries remained occluded.Several lysing agents were given, heparin and agrastat, without positive effect.The patient was reported to be in critical condition.Neurologists, neurosurgeons and neuroradiologists expect a poor outcome if the patient survives.

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 stated to be available for return to the manufacturer for evaluation, but has not yet been returned.However, procedural imaging was provided.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

• Brand Name: SOFIA FLOW 5F
• Type of Device: 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: 18942314
• MDR Text Key: 338145034
• Report Number: 2032493-2024-00228
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00816777025913
• UDI-Public: (01)00816777025913(11)231130(17)261031(10)0000468655
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DA5125ST-E
• Device Lot Number: 0000468655
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Female