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

Model Number	SFR4-4-40-10
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the solitaire fr stent was damaged.The patient was undergoing a thrombectomy of the middle cerebral artery.It was noted the patient's vessel tortuosity was normal.The stroke onset reperfusion time was four hours.It was reported that during the middle cerebral artery thrombectomy, when retrieving the stent, the stent fractured and remained inside the vessel.The stent body became separated from the delivery wire.There was no resistance encountered.A snare device was used to remove the stent from the patient's body.A new stent was then used instead to complete the procedure.There were no patient symptoms or complications associated with this event.The device and any accessories were prepared as indicated in the instructions for use (ifu).
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 received reported that the cause of the event was not determined.The vessel was successfully opened in the procedure, and the patient has recovered.The patient's presenting symptom was a coma.One pass was made with the solitaire prior to the separation.The solitaire fr stent was fully removed from the patient/vessel.
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.
Additional Manufacturer Narrative
Product analysis as found condition: the solitaire fr4-4-40-10 pusher wire was returned for analysis inside a dispenser coil, inside a sealed biohazard bag, and inside a shipping box.The solitaire fr4-4-40-10 stent was not returned with the solitaire pusher wire.Damaged location details: the solitaire fr4-4-40-10 pusher wire broke at ~198.1cm from the proximal end of the pusher wire.The solitaire fr4-4-40-10 marker coil and ptfe shrink tubing were damaged.Testing/analysis: the solitaire fr4-4-40-10 pusher wire broken end was sent out for scanning electron microscopy (sem) failure analysis.The scanning electron microscopy (sem) test results indicate that the broken end exhibited evidence of mechanical damage (shearing/smearing) and dimple overload features.Conclusion: based on the reported information and device analysis, the customer¿s ¿separation¿ report was confirmed, as the returned solitaire fr4-4-40-10 pusher wire was found to be broken.The broken end exhibited evidence of mechanical damage (shearing/smearing) and dimple overload features.Device separation can occur due to vessel tortuosity, delivery and retrieval friction, a higher number of device passes, guide/balloon catheter or intermediate catheter integrity issues (i.E., kinking), pre-existing conditions (stenosis/calcified plaque), hard clots/thrombus entanglement, improper stent/catheter alignment, or microcatheter removal.In this event, the customer reported that the vessel tortuosity was normal, and one pass was made with the solitaire device, ruling out vessel tortuosity and a higher number of device passes as possible causes.Therefore, delivery and retrieval friction, guide/balloon catheter or intermediate catheter integrity issues (i.E., kinking), pre-existing conditions (stenosis/calcified plaque), hard clots/thrombus entanglement, improper stent/catheter alignment, or microcatheter removal could have contributed to the separation complaint.However, the cause could not be determined.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: 23979455
• Report Number: 2029214-2026-00017
• Device Sequence Number: 4552977
• Product Code: NRY
• UDI-Device Identifier: 00847536034709
• UDI-Public: (01)00847536034709(17)280210(10)D018177
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2026

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: SFR4-4-40-10
• Device Catalogue Number: SFR4-4-40-10
• Device Lot Number: D018177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2026
• Supplement Date Received by Manufacturer: 01/11/2026; 03/02/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/30/2026; 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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