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	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter/healthcare provider information is not available due to country privacy laws.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 there was resistance in the proximal portion of the microcatheter during transfer of the solitaire fr stent into the microcatheter.The patient was undergoing surgery for treatment of an ischemic cerebral infarction of the basilar artery (ba).The modified rankin score (mrs) was 4 pre-operatively and 2 post-operatively.The national institutes of health stroke scale (nihss) score was 20 pre-operatively and 5 post-operatively.The thrombolysis in cerebral infarction (tici) score was 1 pre-operatively and 2 post-operatively.The patient was not treated with tissue plasminogen activator (tpa).It was noted the patient's vessel tortuosity was moderate.The time required from onset of cerebral infarction to revascularization was 6 hours.It was reported that the reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The stent properly pushed out of the sheath, and passed through the non-medtronic microcatheter hub, but got stuck at the proximal portion of the microcatheter when advanced.A replacement solitaire stent was used and was passed 2 times.No patient symptoms or complications were associated with this event.Ancillary devices include: non-medtronic microcatheter.
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 there was no damage to the catheter or solitaire pushwire.The tip of the solitaire sheath was secured into the hub of the microcatheter.

• 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: 22544220
• Report Number: 2029214-2025-01633
• Device Sequence Number: 17895920
• Product Code: NRY
• UDI-Device Identifier: 00763000425678
• UDI-Public: (01)00763000425678(17)270823(10)B779438
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 08/18/2025

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: B779438
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 08/18/2025
• Date Device Manufactured: 08/26/2024
• 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