MAUDE Adverse Event Report: Micro Therapeutics, Inc. dba ev3 SOLITAIRE FR4; CATHETER, THROMBUS RETRIEVER

Model Number	SFR4-4-40-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vasoconstriction (2126); Respiratory Failure (2484); Cerebral Edema (4403); Ischemia Stroke (4418); Embolism/Embolus (4438)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury

• 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 ; +1(763)526-5677
• MDR Report Key: 50379094
• Report Number: 2029214-2026-01632
• Device Sequence Number: 9975066
• Product Code: NRY
• UDI-Device Identifier: 00763000425678
• UDI-Public: (01)00763000425678(17)290415(10)D109410
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K183022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: SFR4-4-40-10
• Device Catalogue Number: SFR4-4-40-10
• Device Lot Number: D109410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 08/21/2026
• Supplement Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 04/27/2026
• 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: Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 205 LB