MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR3; CATHETER, THROMBUS RETRIEVER

Model Number	SFR3-6-40-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Nervous System Injury (2689); Ischemia Stroke (4418)
Date of Event	01/15/2024
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
Medtronic received a report that on (b)(6) 2024 re-examination of the head mri revealed a recent intracavitary infarction in the left half oval center.The patient is conscious and the weakness in their left limb is worse than ever.The patient's baseline modified rankin scale (mrs) score is 0, (b)(6) health stroke scale (nihss) is 8.The outcome status is not recovered/resolved.This is not a recurrent or new stroke.This adverse event (ae) is not related to the disease under study or underlying condition.Site assessed that this event did not lead to congenital anomaly, death, disability, hospitalization, or medical intervention and was not considered life-threatening.The site assessed this event is not related to the study devices and possibly related to the study procedure.Pre-procedure modified thrombolysis in cerebral infarction (mtici) score 2b, final post-procedure mtici 2c.
Event or Problem Description
Additional information was received reporting the rationale for relating ae to system or procedure was updated to state this could be a lacunar infarction caused by angiography.Final post-procedure mtici score 2c ; post-procedure 24h nihss 9 and outcome of the event is not recovered/resolved.
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.

• Brand Name: SOLITAIRE FR3
• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19181230
• Report Number: 2029214-2024-00747
• Device Sequence Number: 15200897
• Product Code: NRY
• UDI-Device Identifier: 00847536034792
• UDI-Public: 00847536034792
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K181186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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 Expiration Date: 03/08/2024
• Device Model Number: SFR3-6-40-10
• Device Catalogue Number: SFR3-6-40-10
• Device Lot Number: B351096
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/16/2024
• Date Device Manufactured: 03/10/2022
• 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: Other
• Patient Sex: Female
• Patient Weight: 60 KG