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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Intracranial Hemorrhage (1891); Ischemia Stroke (4418); Embolism/Embolus (4438)
Date of Event	03/31/2024
Type of Reportable Event	Death
Event or Problem Description
Medtronic received information that a patient treated with a solitaire sfr4 stent had a intracerebral hemorrhage.Cranial ct examination showed intracerebral hemorrhage in the left basal ganglia and frontoparietal lobe, and hemorrhagic transformation of ph2 after the stroke type.Nihss score available: 10, mrs: score: 0.Actions taken: besides, albumin, concentrated sodium and furosemide dehydration were used to reduce cranial pressure, blood pressure was controlled below 120 mmhg, sedation and analgesia, and preventive anti-seizure.The event is not resolved.The event was possibly related to the procedure.The event was life threatening.Pre-procedure mtici score: 0 final post-procedure mtici score: 3.
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 a potential compliant of subarachnoid hemorrhage (sah) was observed on 24-hour post procedure follow up ct imaging on (b)(6) 2024.The event is not resolved.Actions taken: besides, albumin, concentrated sodium and furosemide dehydration were used to reduce cranial pressure, blood pressure was controlled below 120 mmhg, sedation and analgesia, and preventive anti-seizure.The event was possible related to the disease under study and underlying condition or disease ¿ not related to systematic and study procedures.
Event or Problem Description
Additional information was received reporting head computerized tomography (ct) without contrast on 2024-04-06 showed a new low-density shadow in the right fronto-parietal lobe and basal ganglia, considering the possibility of cerebral infarction.Re-embolization of the right middle artery was considered.This was a recurrent or new stroke not requiring mechanical thrombectomy.Adverse event (ae) possibly related to the disease under study and possibly related to an underlying condition.Ae did not result from a device deficiency.Other actions taken included stabilize plaque, vegetative nerves, etc.Outcome status not recovered/not resolved.The site assessed this event did not lead to congenital anomaly, death, disability, hospitalization, or medical intervention and was not considered life-threatening.Site assessed this event as not related to the study device or procedure.Sponsor assessed this event as possibly related to the study procedure and devices utilized.Additional information was received reporting ct on 2024-03-31 showed subarachnoid hemorrhage in the left cerebral hemisphere which was considered to be associated with intraoperative vascular traction.Ae possibly related to the disease under study.Not related to an underlying condition.Ae did not result from a device deficiency.Site assessed as possibly related to the study procedure, not related to the device.Ae resulted in concomitant treatment, dehydration therapy.Outcome status not recovered/not resolved.
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 source documents noted the patient experience distal embolization of the target clot from the m2 segment to the m3 segment of the mcr during the index thrombectomy procedure which required an additional pass with the solitaire.It was also noted that the patient died on (b)(6) 2024.Cause of death has not been specified.However, the investigator noted the death was possibly due to the patient disease under study/index stroke.
Additional Manufacturer Narrative
A2: only the year of patient's birth (1955) was provided by the site.Therefore, only the year of the reported birthdate is valid.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 that the sponsor and the site assessed the death as not related to the study procedure or the devices used.Actions taken were rescue treatment such as sputum suction, open airway, balloon assisted ventilation, continuous cardiopulmonary resuscitation, pressure boost, and balancer expansion were given.It was reported at 23:55 on (b)(6) 2024 the patient suddenly pale, weak pulse, pulse 12 times/minute.Blood pressure, pupil 3+.Respiratory and circulatory failure occurred.
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.
Event or Problem Description
Additional information received that the patients baseline mrs score was 0 and post procedure was 4.It was stated on april 17th when the patient underwent resuscitation the patient had breathed 5 times per minute.
Event or Problem Description
Medtronic received a report that 3d rotational angiography revealed lefty middle cerebral artery (mca) inferior trunk, superior branch thrombosis ectopia, clinically significant on (b)(6) 2024.This was not a recurrent or new stroke.Thrombectomy and recanalization, part of the thrombus was not removed, resulting in ectopia.This adverse event (ae) is probably related to the disease under study and not related to an underlying condition or disease.Ae did not result from a device deficiency.Modified rankin scale (mrs) score 0, national institutes of health stroke scale (nihss) 10.This event was not treated by blood transfusion, concomitant treatment, physical therapy, or surgical procedure.This event led to percutaneous intervention.The outcome status is not recovered/not resolved.This event did not lead to congenital anomaly, death, disability, hospitalization, or medical intervention and is not considered life-threatening.The site assessed this event as possibly related to the study procedure.The sponsor assessed this event as possibly related to the study device utilized and causally related to the study procedure.Pre-procedure mtici score 0, post-procedure mtici score 3.
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 reported previous report of thrombosis ectopia should have been displacement of thrombus.Thrombosis translocation.Cerebral artery embolism in same territory.

• 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, TN 92618 ; 7635265677
• MDR Report Key: 19085651
• Report Number: 2029214-2024-00629
• Device Sequence Number: 15229614
• 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): 08/13/2024

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 Model Number: SFR4-3-20-10
• Device Catalogue Number: SFR4-3-20-10
• Device Lot Number: B641026
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 04/11/2024; 05/13/2024; 05/31/2024; Not provided; Not provided; 07/24/2024; 07/29/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 04/15/2024; 05/16/2024; 06/03/2024; 06/10/2024; 07/24/2024; 07/26/2024; 08/13/2024
• Date Device Manufactured: 10/17/2023
• 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: Death; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 60 KG