MAUDE Adverse Event Report: Micro Therapeutics, Inc. dba ev3 SOLITAIRE FR4; CATHETER, THROMBUS RETRIEVER

Model Number	SFR4-6-40-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Stenosis (2263); Foreign Body In Patient (2687)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that the solitaire fractured and remained inside the patient's body.It was reported that when the physician used the sfr4-6-40 in (b)(6), a solitaire device fractured and remained inside the patient's body.Due to patient privacy concerns (personal data protection), the physician is currently unwilling to disclose the patient's condition.There was separation.The patient had vessel stenosis proximal to the thrombus site.The stent remains in the patient's internal carotid artery (ica).The pushwire was discarded by the hospital after the procedure and is not available for return.The physician did not attempt to detach the stent.It was unknown if there were any patient symptoms or complications associated with this event.It was unknown if the reported device and any accessory devices prepared as indicated in the ifu.The patient is alive with no injury.Ancillary devices include a phenom microcatheter.
Additional Manufacturer Narrative
B3: exact event date not reported, date reflects month and year of the event.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 ; +1(763)526-5677
• MDR Report Key: 50753805
• Report Number: 2029214-2026-01833
• Device Sequence Number: 9203212
• Product Code: NRY
• UDI-Device Identifier: 00763000425739
• UDI-Public: (01)00763000425739(17)270520(10)B735994
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: B735994
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 05/22/2024
• 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