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

Model Number	SFR4-3-40-10
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2024
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 the patient was undergoing treatment for m1d ischemic cerebral infarction.It was noted that the patient's blood vessel tortuosity was strong.The thrombolysis in cerebral infarction (tici) score baseline was unknown and after the procedure was 2b.Intravenous tpa was not contraindicated, and notably, there were zero passes with the device during the procedure.The time required from onset of cerebral infarction to revascularization/revascularize was 120 minutes it was reported that after induction into m1d after a microcatheter, solitaire fr 3-40 was inserted into trevotrak 21 microcatheter.When the solitaire was inserted in about two-thirds, there was a strong resistance in the center of the catheter, but it was still inserted.It became difficult to insert the stent afterwards, so the stent was removed.Upon checking the stent, kinks were observed at the stent junction.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Ancillary devices include a chikai14 guide wire.
Additional Manufacturer Narrative
Updated: 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 patient¿s baseline condition (tici, nihss, etc.) was unknown.Post-thrombectomy, the patient¿s condition was assessed as tici2c.The causes of both the resistance and the kink were unknown.Continuous saline flush was administered and maintained as indicated in the ifu.The procedure was completed after the device was replaced with another company¿s device.

• 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: 22770612
• Report Number: 2029214-2025-01790
• Device Sequence Number: 13041651
• Product Code: NRY
• UDI-Device Identifier: 00763000367626
• UDI-Public: (01)00763000367626(17)270130(10)B687130
• 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): 10/24/2025

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: SFR4-3-40-10
• Device Catalogue Number: SFR4-3-40-10
• Device Lot Number: B687130
• 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: 07/13/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 10/24/2025
• Date Device Manufactured: 02/01/2024
• 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