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

Model Number	SFR4-3-20-10
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2025
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 on (b)(6) 2025, the patient underwent thrombectomy in the m2 segment of the middle cerebral artery.The surgeon used a 017 microcatheter to deliver an sfr4-3-20-10 stent.During the operation, it was found that the stent could not be pushed out after being pushed to the distal end.The surgeon subsequently replaced the stent and successfully pushed it out.No patient symptoms or further complications were reported as a result of this event.
Event or Problem Description
Additional information was received stating that the cause of the resistance was not determined.A continuous saline flush was administered and maintained as indicated in the ifu.The microcatheter was not a medtronic product.
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
H3: product analysis #(b)(4):equipment used: video inspection system (m-81805), camera (panasonic lumix dmc-zs5) as found condition: the solitaire fr4-3-20-10 stent device was returned for analysis inside a sealed biohazard bag and a shipping box.The reported non-mdt catheter was not returned with the stent.Damaged location details: the solitaire fr4-3-20-10 stent¿s finger markers were examined inside the introducer sheath.All finger markers were aligned correctly, and no damages were noted.The stent¿s working and non-working lengths strut 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 found on the pushwire, and no other anomalies were found.Testing/analysis: the solitaire fr4-3-20-10 stent device was tested for resistance using an in-house rebar 14 catheter.The rebar 14 catheter has an inner diameter (id) of 0.017 inches, the same inner diameter (id) as the reported non-mdt catheter used by the customer.The solitaire stent passed through the catheter hub and tip without issues.Conclusion: based on the reported information and device analysis, the customer¿s ¿resistance during delivery/retrieval¿ complaint could not be confirmed, as no issues were encountered while testing the returned solitaire fr4-3-20-10 stent device, and no damages were noted on the device.Therefore, the root cause of the resistance complaint could not be determined.Possible causes include vessel tortuosity, an incompatible/damaged catheter, or a lack of continuous flush with heparinized saline during delivery.In this event, the reported non-mdt catheter was compatible with the solitaire fr4-3-20-10 stent device, as it had a labeled inner diameter (id) of 0.017 inches, ruling out incompatibility as a potential cause.In addition, the customer stated that a continuous saline flush was administered and maintained; however, it was not specified if it was with heparinized saline.Therefore, we cannot rule out a lack of continuous flush with heparinized saline during the delivery as a possible cause.Thus, vessel tortuosity, a damaged catheter, or a lack of continuous flush with heparinized saline during delivery could have contributed to the failure complaint.Since the reported non-mdt catheter was not returned, any contribution to the failure issue 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 X
• 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: 21644160
• Report Number: 2029214-2025-00707
• Device Sequence Number: 7694719
• Product Code: NRY
• UDI-Device Identifier: 00763000367619
• UDI-Public: 00763000367619
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2025

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: SFR4-3-20-10
• Device Catalogue Number: SFR4-3-20-10
• Device Lot Number: B695310
• 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: 03/17/2025
• Supplement Date Received by Manufacturer: 03/21/2025; 05/08/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/16/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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 Age: 64 YR
• Patient Sex: Female