MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR4; CATHETER, THROMBUS RETRIEVER

Model Number	SFR4-6-40-10
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Stenosis (2263); Foreign Body In Patient (2687)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that a solitaire fr stent encountered resistance, there was pushwire break/separation, and the tips broke off in m1 during retrieval.The stent remained in the patient and the broken segment remained in m1.Patient symptoms or complications associated with this event were reported as "m1 gone post stroke when solitaire broke".Stroke onset to reperfusion time was reported as 0.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The pushwire was not torqued during the procedure.
Additional Manufacturer Narrative
Update b5.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received.The cause of the pushwire break/separation was determined to be vessel tortuosity and calcifica tion.Similarly, the cause of the broken tips was clarified as vessel tortuosity with calcification, rather than "stroke." resistance in the catheter was noted at the distal end.The used catheter was a non-medtronic device.
Event or Problem Description
Additional information was received stating that the vessel tortuosity was severe.The patient¿s recovery status and symptoms related to the reported issue are unknown.During the procedure, "tips broke off in m1 during retrieval" referred to the device snapped and lodged in the m1 segment during retrieval.The reported complication, "m1 gone post stroke when solitaire broke," refers to zero perfusion into the m1 segment.The procedure was not completed, and no medtronic product was used as a replacement.The cause of the resistance was determined to be extreme tortuosity, and resistance was encountered upon retrieval.The condition being treated was stroke, and the patient¿s post-thrombectomy condition was tici 0.There may have been vessel stenosis proximal to the thrombus site.The clot was characterized as hard, and the anatomical location of the solitaire was m1.The patient will not undergo further intervention to remove the solitaire, and the vessel was not revascularized.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received that the cause of the pushwire break/separation was noted to be vessel tortuosity/calcification.Catheter resistance occurred in the distal section.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SOLITAIRE FR4
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 23743995
• Report Number: 2029214-2025-02559
• Device Sequence Number: 13299563
• Product Code: NRY
• UDI-Device Identifier: 00763000425739
• UDI-Public: (01)00763000425739(17)271030(10)B813703
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/04/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SFR4-6-40-10
• Device Catalogue Number: SFR4-6-40-10
• Device Lot Number: B813703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 01/23/2026; 01/23/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/15/2026; 02/03/2026; 02/04/2026
• Date Device Manufactured: 11/04/2024
• 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: Other
• Patient Sex: Unknown