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

Model Number	SFR4-3-20-10
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
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 non-medtronic intermediate catheter was advanced to the distal portion of m1.Thrombectomy was attempted several times using a direct aspiration first pass technique (adapt), but the thrombus could not be retrieved, so the solitaire fr thrombus retrieval stent (sfr) was used to perform a combined technique.When the sfr was inserted into a non-medtronic microcatheter and the push wire was pressed, there was a stronger resistance than usual.While resistance was felt, the push wire was continuously advanced, resulting in the sfr becoming stuck within the catheter.All microcatheters were removed and replaced with new ones of the same model.Adapt was performed again using a non-medtronic intermediate catheter, resulting in recanalization, and the procedure was safely completed.No patient symptoms or complications were associated with this event.The patient was undergoing thrombectomy surgery for treatment of poor blood flow in the distal (m2) segment of the right middle cerebral artery (mca).The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).Ancillary devices included an 8f optima guidecatheter, stryker track21 microcatheter, and synchro select standard guidewire.
Event or Problem Description
Additional information received that lesion characteristics include on the left side, around the middle of the mca, the vascular system is 2.3 mm.Vessel tortuosity was moderate.The patient¿s post-thrombectomy condition was tici3.There was resistance in the middle of the catheter.A continuous saline flush was administered and maintained as indicated in the ifu.Vecta 46 was the intermediate catheter by stryker.
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 X
• 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: 23525946
• Report Number: 2029214-2025-02376
• Device Sequence Number: 9084223
• Product Code: NRY
• UDI-Device Identifier: 00763000367619
• UDI-Public: (01)00763000367619(17)270913(10)B788994
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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 Model Number: SFR4-3-20-10
• Device Catalogue Number: SFR4-3-20-10
• Device Lot Number: B788994
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/08/2025
• Date Device Manufactured: 09/17/2024
• 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
• Patient Sex: Unknown