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

Model Number	SFR3-4-40-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	06/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that the patient experienced new acute ischemic infarction in primary unaffected vascular territory at left caudate nucleus on follow up imaging.Modified rankin scale (mrs) score 0, national institutes of health stroke scale (nihss) 32.There was an onset date of (b)(6) 2023 and the patient recovered with sequelae/issue resolved on (b)(6) 2023.This event did not lead to congenital anomaly, death, disability, hospitalization, or medical intervention and was not considered life-threatening.This adverse event (ae) was probably related to the disease under study and possibly related to underlying condition or disease.This ae did not result from a device deficiency.The site assessed this event as not related to the study devices or procedure.The sponsor assessed this event as possibly related to the study devices and causally related to the study procedure.The pre-procedure mtici score was 0, post-procedure mtici score 3.Refer to manufacturer report 2029214-2023-02395 for related device.
Additional Manufacturer Narrative
Refer to manufacturer report 2029214-2023-02395 for related device.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
Additional information was received that there were no symptoms reported as a result of the event.Nihss was 25 at 24 hours post procedure and 14 at 7 days post.There was no neurologic deterioration at the time of the event.At day 90, mrs 1 was reported.It was noted that the event did not result in patient disability.
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.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: 18348370
• Report Number: 2029214-2023-02396
• Device Sequence Number: 20384083
• Product Code: NRY
• UDI-Device Identifier: 00847536034761
• UDI-Public: 00847536034761
• 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,Followup
• Report Date (Section B): 05/10/2024

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: 08/10/2024
• Device Model Number: SFR3-4-40-10
• Device Catalogue Number: SFR3-4-40-10
• Device Lot Number: B432355
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: 12/21/2023; 04/19/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/19/2024; 05/10/2024
• Date Device Manufactured: 08/16/2022
• 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
• Patient Weight: 95 KG