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); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
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
It was reported that the solitaire device was used during a procedure to treat an ischemic stroke in the left m1 segment.The patient had a baseline mrs score of 4.During the intervention, resistance was encountered while retrieving the solitaire device, and difficulty was noted advancing the solitaire device.It was observed that no flush was going through the catheter, prompting the use of a new catheter and resheathing of the solitaire.On the second pass in the m1, the solitaire could not be pulled back into the basket of the anaconda device, and the stent separated from the delivery wire.A second solitaire device was introduced, and both devices were removed; however, the proximal marker remained in the patient in the m4 segment, and a broken segment of the pushwire was not removed, resulting in retained device fragments.No injury was confirmed from the device defect, but the patient did not recover well from the stroke and had a mrs score of 2 after the procedure, indicating slight disability.The stroke onset to reperfusion time was 3+ hours.It was noted that 3-4 passes were made with the device.The patient's vessel tortuosity was normal. the devices were prepared according to the instructions for use (ifu).The pushwire broke in the distal section, and had not been torqued during the procedure.
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 was received stating that the physician did not feel the detached device had any effect on the patient outcome.The cause of the event was not determined.Initially a continuous saline flush was not administered.However, when this was discovered, the physician removed and discarded the catheter and pulled a new one where continuous flush was maintained.The information is confirmed by the physician.
Additional Manufacturer Narrative
H3: product analysis.As found condition: the solitaire x pusher was returned within a shipping box and a plastic bio-pouch.Visual inspection/damage location details: the solitaire x pusher was found bent at ~193.0cm from the pusher proximal end.The solitaire x pusher was found broken within the shrink tubing at ~194.5cm from the pusher proximal end.The solitaire x pusher marker coil was found still intact within the shrink tubing.The shrink tubing was found stretched between the solitaire x pusher broken end and the proximal end of the marker coil.The sent was not returned.Testing/analysis: the pusher diameter at the broken end was measured to be 0.00551¿.When compared to the product drawing, the pusher break likely occurred within the distal tapered section.The broken pusher was sent out for sem failure analysis.Based on sem examination of the fracture surface, the broken wire is believed to have failed due to tensile overload.In addition, dimple rupture features were observed on the examined fracture surface.A distinct bend in the wire immediately adjacent to the fracture surface was observed.Conclusion: based on the device analysis and reported information, the customer¿s ¿marker separation from stent¿ report could not be confirmed.The stent was not returned; therefore, an analysis could not be performed.Regarding the customer¿s ¿resistance during delivery/retrieval¿ report, the issue could not be confirmed.However, the customer¿s ¿pushwire break/separation¿ report was confirmed as the solitaire x pusher was found broken.Possible causes of ¿resistance¿ include using an incompatible catheter, catheter damage, patient vessel tortuosity, or not maintaining a continuous flush.The patient vessel tortuosity was normal and unlikely to contribute to the reported resistance.The catheter used in the event was not returned.Therefore, an analysis could not be performed, and any contributing factors could not be assessed.As a continuous flush was not maintained this likely contributed to the reported resistance.However, the cause of the resistance could not be determined.Possible causes of pushwire break/separation include intracranial stenosis, presence of calcified plaque, number of passes made with the device, delivery and retrieval friction, guide/balloon catheters or intermediate catheter integrity issues such as kinking within the shaft, or hard clots or thrombus entanglement with overbending during the retraction process.Information regarding intracranial stenosis or the presence of calcified plaque was not reported.The catheter used in the event was not returned.Therefore, an analysis could not be performed, and any contributing fact ors could not be assessed.In this event, it is likely that the higher number of passes made with the solitaire x device (3-4) and the reported resistance during delivery/retrieval contributed to the pusher break/separation.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 stating that the event did not involve a medtronic catheter, but was used through an anaconda.

• 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: 22821608
• Report Number: 2029214-2025-01833
• Device Sequence Number: 15890365
• Product Code: NRY
• UDI-Device Identifier: 00763000425739
• UDI-Public: (01)00763000425739(17)280417(10)D034394
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 10/13/2025

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: D034394
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 08/16/2025; 09/17/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/09/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2025
• 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
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 77 YR
• Patient Sex: Female