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); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The specific event date was not reported to medtronic and is, therefore, unknown at the time of this report 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.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 separated from the delivery system.It was reported that the reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).During the thrombectomy procedure, the solitaire stent became detached (broke off) from the delivery system on the first pass.Another solitaire device was used to retrieve the one that had detached inside the vessel and the procedure was completed using a medtronic device.No patient symptoms or complications were associated with this event.
Additional Manufacturer Narrative
Updated: a4, b2, b5 and h6.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 condition being treated was ischemic stroke, and the patient presented with occlusion of the middle cerebral artery (mca), resulting in left-side weakness.The occlusion was located in the right mca, and vessel tortuosity was moderate.The characteristics of the clot were unknown, as were the patient¿s baseline tici and nihss scores.After thrombectomy, the patient achieved a tici 3 result.The stroke onset to reperfusion time was from 20:36 to 21:36.Resistance was felt as the device passed through the valve, but inspection of the solitaire device showed it was fine; upon reinsertion, there was a little friction, and during retrieval, it was found to be detached.Another solitaire device was used to retrieve the detached one.The solitaire device was not torqued during delivery or retrieval, and there was no vessel stenosis proximal to the thrombus site.It is unknown if the microcatheter tip covered the solitaire device¿s proximal marker during retrieval.The detachment was noticed during retrieval, and the cause of the malfunction was not determined.

• 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: 22589550
• Report Number: 2029214-2025-01687
• Device Sequence Number: 9154643
• Product Code: NRY
• UDI-Device Identifier: 00763000425739
• UDI-Public: (01)00763000425739(17)260803(10)B606970
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 09/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2026
• Device Model Number: SFR4-6-40-10
• Device Catalogue Number: SFR4-6-40-10
• Device Lot Number: B606970
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 09/25/2025
• Date Device Manufactured: 08/07/2023
• 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
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 75 KG