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	Intracranial Hemorrhage (1891); Ventilator Dependent (2395); Nervous System Injury (2689); Cerebral Edema (4403); Ischemia Stroke (4418); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440); Decreased Level of Consciousness (4591)
Date of Event	12/17/2023
Type of Reportable Event	Serious Injury
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.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.
Event or Problem Description
Medtronic received a report that head computerized tomography (ct) re-examination on (b)(6) 2023 showed that the right cerebral hemisphere had a large infarction and the right cerebral edema was obvious.Considering the formation of the cerebral hernia.Per physical examination, the patient was in sedative and analgesic state, mechanical ventilation, bilateral pupils were abnormally large, light reflux disappeared, limbs did not move autonomously.Ct re-examination on (b)(6) 2023 showed that the right cerebral edema was still obvious.Mannitol dehydration reduced cranial pressure accompanied by cerebral hernia.Ct re-examination on (b)(6) 2023 showed cerebral edema was still obvious and mannitol dehydration was continued to reduce cranial pressure.On (b)(6) 2024 the patient was in stable condition and was discharged from the hospital to continue inpatient rehabilitation and exercise treatment.This adverse event (ae) was not a recurrent or new stroke.Ae was possibly related to the disease under study or an underlying condition.The patient has not recovered and the issue not resolved.Baseline modified rankin scale (mrs) score 0, baseline national institutes of health stroke scale (nihss) 18.The 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 as not related to the study device and possibly related to the study procedure.The sponsor assessed this event as possibly related to the study procedure.Pre-procedure mtici score 0, post-procedure 2c.
Event or Problem Description
Additional information was received reporting on 2023-dec-17 hemorrhage transformation after cerebral infarction was diagnosed.Patient's vital signs were stable after operation.Patient returned to the icu with tracheal intubation.This adverse event (ae) was possibly related to the disease under study.Ae was not related to an underlying condition or device deficiency.The patient has not recovered, and the issue not resolved.Baseline modified rankin scale (mrs) score 0, baseline national institutes of health stroke scale (nihss) 18.The 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 as not related to the study device or procedure.The sponsor assessed this event was possibly related to the study procedure.Pre-procedure mtici score 0, post procedure 2c.Additionally it was reported that on 2023-dec-17 re-examination of head ct revealed a small amount of local bleeding at the right frontal subarachnoid hemorrhage site.The patient's trachea incision was assisted by mechanical ventilation.The sponsor assessed this event as causally related to procedure and possibly related to the devices utilized.Additional information was received updating action result of diagnostic imaging to no and removing 2023-12-25 result of right calf intermuscular venous thrombosis.
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 ae of deep vein thrombosis still exists in the database and results provided in the ae description ¿ on (b)(6) 2023, the right calf intermuscular vein thrombosis was shown (complete type, acute stage).¿.
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.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.
Event or Problem Description
Additional information was received reporting at day 90 follow up visit on (b)(6) 2024 nihss 15, mrs 4.The event was possibly related to the patient index condition, underlying condition, and procedure.The event was not related to the medtronic device.There was no additional intervention or additional treatment required to address the adverse events and the event was not life-threatening, no hospitalization, or disability.Additional information was received reporting than on (b)(6) 2023 the right calf intermuscular vein thrombosis was shown (complete type, acute stage).On (b)(6) 2024 vte was at high risk, anticoagulants were started, coagulation indexes and bleeding conditions were closely monitored and timely adjustments were made.Patient's baseline modified rankin scale (mrs) score was 0, baseline national institutes of health stroke scale (nihss) 18.The rationale for relating adverse event (ae) to system or procedure was right side catheterization is easy to form thrombus.Ae not related to disease under study or underlying condition.Ae not result from a device deficiency.The patient has not recovered, issue not resolved.The site assessed this event as not leading to congenital anomaly, death, disability, hospitalization, or medical intervention and not considered life-threatening.The site assessed this event as possibly related to the study procedure.Not related to the study device.
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 surgical intervention was required.
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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 18896927
• Report Number: 2029214-2024-00425
• Device Sequence Number: 6410379
• 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,Followup,Followup,Followup
• Report Date (Section B): 09/05/2024

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: 02/17/2025
• Device Model Number: SFR3-6-40-10
• Device Catalogue Number: SFR3-6-40-10
• Device Lot Number: B521939
• 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: 03/11/2024
• Supplement Date Received by Manufacturer: 03/15/2024; 03/18/2024; 03/21/2024; 04/19/2024; 08/21/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 03/18/2024; 03/20/2024; 04/11/2024; 05/10/2024; 09/05/2024
• Date Device Manufactured: 02/20/2023
• 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: Required Intervention; Life Threatening
• Patient Sex: Female
• Patient Weight: 115 KG