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

Model Number	SFR4-4-40-10
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the solitaire experienced resistance during retrieval within the distal section of the catheter.The patient was being treated for large vessel occlusion.The stroke onset to reperfusion time was 2 hours.It was noted the patient's vessel tortuosity was moderate.It was reported that during the thrombectomy process, the stent and catheter were in place.However, when pulling the stent back, the stent could not be retrieved into the stent catheter.After multiple unsuccessful attempts, it was removed from the body.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.
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
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 catheter flush was administered per ifu during the procedure.1 pass was made with the solitaire.The occlusion was in the middle cerebral artery.
Additional Manufacturer Narrative
H3: the solitaire fr4-4-40-10 stent device was returned for analysis, stuck inside the rebar 18 catheter.The solitaire fr4-4-40-10 stent¿s working and non-working length struts were in good condition.No irregularities were found outside the proximal marker, and the marker coil was in good condition.No bends or kinks were observed on the pusher wire.The rebar 18 catheter¿s tip and marker were examined, and no damage was noted.The catheter body was kinked at ~1.0cm to 2.0cm from the distal tip.No voids or flashes were noted on the catheter hub.No other anomalies were found.The solitaire fr4-4-40-10 stent device was removed from the rebar 18 catheter lumen.The rebar¿s 18 catheters¿ total and usable lengths were measured within specifications.The catheter was flushed with water and was found patent.It was tested using an in-house 0.021-inch mandrel, which passed through the hub without issue; however, resistance was observed at the damaged locations.Based on the reported information and device analysis, the customer¿s ¿resistance¿ report was confirmed, as the returned solitaire fr4-4-40-10 stent device was stuck inside the rebar 18 catheter and was damaged.Possible causes include vessel tortuosity, an incompatible/damaged catheter, the user not maintaining the correct flush rate, and a lack of continuous flush with saline/heparinized saline during the procedure.In this event, the customer stated that the vessel¿s tortuosity was moderate, the rebar 18 catheter used was compatible with the solitaire fr4-4-40-10 stent device, as it has a labeled inner diameter (id) of 0.021 inches and catheter flush was administered, ruling out vessel tortuosity, an incompatible catheter, and a lack of continuous flush with saline/heparinized saline during the procedure as potential causes.Therefore, a damaged catheter or the user not maintaining the correct flush rate could have contributed to the retrieval resistance complaint.However, the cause of the resistance 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: 22738486
• Report Number: 2029214-2025-01772
• Device Sequence Number: 9120865
• Product Code: NRY
• UDI-Device Identifier: 00847536034709
• UDI-Public: (01)00847536034709(17)280205(10)D017570
• 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): 10/09/2025

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: SFR4-4-40-10
• Device Catalogue Number: SFR4-4-40-10
• Device Lot Number: D017570
• 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: 08/03/2025
• Supplement Date Received by Manufacturer: 08/11/2025; 10/01/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/04/2025; 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• 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