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); Rupture (2208); Ventilator Dependent (2395)
Date of Event	06/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is reported at this time based on additional information received with indicated a reportable event.A separate report will be submitted for the rebar microcatheter.Assessment of the event did not note any possible relationship with the react catheter.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 information about a patient who underwent a procedure in which a solitaire stent and react catheter was used.During the operation, it was reported that there was a rupture of a branch of the left anterior choroidal artery, with bleeding breaking into the left lateral ventricle.Following coil embolization of the left anterior choroidal artery, the subsequent angiography did not show any contrast extravasation.A react 71 catheter was coaxially advanced but couldn't pass the ophthalmic artery.A suction catheter was positioned at the c4 segment.2023-nov-14 e1 (hcp, rep, for, sdy): event date occurred 17-jun-2023 during the index procedure.Additional information received reported the rupture occurred causing anterior choroidal artery hemorrhage.Immediate action was taken to neutralize the heparin effects and the rupture/hemorrhage was addressed with implantation of 2 embolization coils.Baseline mrs was 5, nihss was 29, and mtici was 0.Post-procedure mtici was 2a.The event was considered life-threatening but did not result in new patient disability or prolonged hospitalization.The patient was noted to be recovered and event resolved on 05-jul-2023.It was noted the event was possibly due to the patient index stroke.The site assessed the event as possibly related the procedure but not related to the solitaire or accessory devices.The medtronic study sponsor assessment concluded it was possible the event was related to the solitaire and/or rebar microcatheter.
Event or Problem Description
Additional information was received updating the adverse event info to anterior chorodial artery hemorrhage, neutralize heparin immediately echelon-10 was taken and 1*3, 2*2 spring coil was released into the anterior chorodial artery via microcatheter.Re-examiniation of the angiography showed that the contrast media had leaked out.The date the patient recovered and the issue resolved was updated to (b)(6) 2023.The site assessment of life threatening "yes" was updated to "no." the site assessment of medical intervention "no" was updated to "yes.".
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 ct showed local ventricular hemorrhage on (b)(6) 2023.On (b)(6) 2023 the density shadow was absorbed more than before, the patient was sedated, assisted breathing, symptomatic treatment.On (b)(6) 2023 sedation was stopped and spontaneous respiration resumed with low albumin and abnormal coagulation function.Family members decided to transfer to a lower level hospital for continued treatment.The patient was discharged.Modified rankin scale (mrs) score 5, national institutes of health stroke scale (nihss) 29.This event did not lead to congenital anomaly, death, disability, hospitalization, 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 assessment stated per medical assessment event is possibly related to the device solitaire and microcatheter rebar.Pre-procedure mtici 0, final post-procedure mtici 2a.
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.
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 on 11-apr-2024 the cec adjudicated this event as serious, causal to the study procedure, and not related to study devices utilized.

• 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: 18212117
• Report Number: 2029214-2023-02289
• Device Sequence Number: 15064040
• 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
• Report Date (Section B): 05/07/2024

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: 10/19/2024
• Device Model Number: SFR3-6-40-10
• Device Catalogue Number: SFR3-6-40-10
• Device Lot Number: B465999
• 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: 11/23/2023
• Supplement Date Received by Manufacturer: 12/11/2023; 02/05/2024; 04/12/2024
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 01/05/2024; 02/06/2024; 05/07/2024
• Date Device Manufactured: 10/21/2022
• 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: Required Intervention; Life Threatening
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 90 KG