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

Model Number	SFR3-4-20-05
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stenosis (2263); Ischemia Stroke (4418); Embolism/Embolus (4438)
Date of Event	04/06/2023
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 the patient experienced multiple subacute cerebral infarcts in the left cerebral hemisphere region.The cause of this is that the left middle cerebral artery remains stenotic and there is remnant appendage embolization.On review at time of discharge, the hyperdense shadow was reduced, then the subject was discharged as the requirement of the family.The patient's baseline modified rankin scale (mrs) score is 0, baseline national institutes of health stroke scale (nihss) 15.This is not a recurrent or new stroke.The adverse event (ae) is not related to the system or procedure and not related to underlying patient condition.Ae did not result from device deficiency.The onset date was 2023-04-06, and the issue recovered/resolved on 2023-04-10.Per site, 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 as not related to the study device or procedure.The sponsor assessed this event as possibly related to the study procedure and device.Pre-procedure mtici score 0, final post-procedure mtici 3.Ancillary devices include a zhongtian aspiration catheter.

• 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: 18995715
• Report Number: 2029214-2024-00526
• Device Sequence Number: 7605318
• Product Code: NRY
• UDI-Device Identifier: 00847536034747
• UDI-Public: 00847536034747
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161879
• 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
• Report Date (Section B): 03/28/2024

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: 04/20/2024
• Device Model Number: SFR3-4-20-05
• Device Catalogue Number: SFR3-4-20-05
• Device Lot Number: B373065
• 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: 03/20/2024
• Initial Report FDA Received Date: 03/28/2024
• Date Device Manufactured: 04/22/2022
• 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: Male