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	02/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information regarding a patient who underwent a mechanical thrombectomy procedure in a which a solitaire x stent retriever was used.The patient's pre-procedure mtici was 0, mrs was 0, and nihss was 18.During the procedure, embolization of the left anterior cerebral artery was noted which was associated with fresh thrombosis around the non-medtronic access catheter.It was reported: "the thrombus escaped to the anterior cerebral artery, and it was ananized immediately after stent thrombectomy without new cerebral infarction in this area." the event was not life-threatening and did not require additional intervention.The event did not result in patient disability or prolonged hospitalization.Final post-procedure mtici was 3.The event was not associated with a device deficiency.The event was resolved and the patient was recovered without additional treatment on the same date as the procedure, (b)(6) 2024.The site assessment concluded the event was probably related to the procedure but not the study device(s) or the patient condition.The medtronic study sponsor assessment concluded the event was causally related to the procedure and possibly to study devices utilized.Ancillary device: stryker catalyst 6 aspiration catheter.Additional information received reported the information was corrected.The thrombus escaped to the anterior cerebral artery, and it was analyzed immediately after stent thrombectomy without no new cerebral infarction in this area.
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 during the postoperative withdrawal of the access catheter, the access thrombosis appeared and escaped to the anterior cerebral artery, which was reconnected after thrombolysis through the anterior cerebral artery stent.
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: 19630496
• Report Number: 2029214-2024-01149
• Device Sequence Number: 15621415
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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: 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: 05/31/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 07/24/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 90 KG