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

Model Number	SFR4-3-20-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	04/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id: react-71 (b520546).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 subject was admitted to the hospital on (b)(6) 2024 due to sudden unconsciousness for 4 hours.Head, chest, and upper abdomen scan were performed to show the subject's stroke.During the operation, the subject underwent mechanical thrombectomy, and the thrombus escaped to the m2-l segment when the thrombus was extracted.After mechanical thrombectomy and the microcatheter thrombectomy, the m2-l segment was reevacuated.The event was not a recurrent or new stroke.The event was possibly related to the disease under study and underlying condition or disease.The event did not result from a device deficiency.Pre-procedure mtici was intermediate and post procedure was 3.There was treatment.The outcome was recovered/resolved on (b)(6) 2024.The site assessed as not related to the procedure or devices, however, the sponsor assessed the event as serious and causally related to the study procedure and possibly to the devices utilized.
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
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 patient details: mrs score 1 and nihss score 18.
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 that per cec the event was not related to the solitaire or rebar 27.
Event or Problem Description
Additional information was received that the event was not treated with a blood transfusion.
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 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: 19191904
• Report Number: 2029214-2024-00758
• Device Sequence Number: 20909232
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/03/2025

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: 07/16/2026
• Device Model Number: SFR4-3-20-10
• Device Catalogue Number: SFR4-3-20-10
• Device Lot Number: B596486
• 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: 05/01/2024; 07/03/2024; 09/24/2024; 12/09/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 05/17/2024; 07/26/2024; 10/15/2024; 01/03/2025
• Date Device Manufactured: 07/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 60 KG