MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR4; CATHETER, THROMBUS RETRIEVER

Model Number	SFR4-4-40-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Rupture (2208); Ischemia Stroke (4418)
Date of Event	03/28/2024
Type of Reportable Event	Death
Event or Problem Description
Medtronic received a report that a solitaire patient underwent treatment to remove the intracerebral hematoma.The patient had not recovered/resolved.Head computer tomography (ct) without contrast resulted in tight temporal lobe hemorrhage on (b)(6) 2024.Patient nihss score: 11.Event was assessed as safe and possibly related to the study procedure.
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 pre-procedure mtici score: 0, final post-procedure mtici score 2c ; post-procedure 24h nihss 22 and outcome of the event is fatal.The outcome date is (b)(6) 2024.The event was treated with a surgical procedure; other action was taken: removal of intracerebral hematoma; prolongation of existing hospitalization, nourishing nerves, preventing seizures, protecting liver, protecting kidney, diuresis, correcting coagulation function.Causality assessment of temporal lobe hemorrhage provided as: not related to procedure, device, and disease under study; possible related to underlying condition or disease; may be related to thrombectomy.Site assessed as possibly related to procedure.
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 rpoerted the patient passed away on 2024-may-16.The event intraventricular hemorrhage (ivh) was possible related to procedure, not related to the devices, possible related to disease under study and underlying condition or disease.-, rationale for the relationship to system or procedure was noted by site as ¿ maybe related to thrombectomy¿.Intracranial hemorrhage and cerebral hernia formation, surgical procedure ¿ intracerebral hematoma removal, intracranial decompression, dural dilatation repair suture, decompressive craniectom,y prolongation of existing hospitalization - nourishing nerves, preventing seizures, protecting liver, protecting kidney, diuresis, correcting coagulation function.
Additional Manufacturer Narrative
H6.Device eval method code updated based on all available information.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 that thrombus rupture was inevitable during the thrombectomy.The clot ruptures into the new vascular area causing a new embolism during the surgery.The event is assessed as causally related to study procedure and possible related to study device utilized.
Event or Problem Description
Additional information received reported that the on 23-sep-2024 the cec adjudicated this event as causal to the study procedure.Additional information received reported that the adverse event (ae) was listed as probably related to the disease/condition.The event weas not a new or recurrent stroke.The ae was not a result from a device deficiency.Postoperative cerebral infarction progression led to the patient¿s death.Patient details: mrs score 0.Sae reporting of death/not related to study procedure of study device utilized.Ancillary devices: disposition: catheter zhongtian 21 microcatheter.
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 FR4
• 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: 19319825
• Report Number: 2029214-2024-00913
• Device Sequence Number: 12660620
• Product Code: NRY
• UDI-Device Identifier: 00847536034709
• UDI-Public: 00847536034709
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K183022
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/15/2024

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: 05/17/2026
• Device Model Number: SFR4-4-40-10
• Device Catalogue Number: SFR4-4-40-10
• Device Lot Number: B567342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 05/17/2024; 06/13/2024; 07/05/2024; 09/24/2024; 10/12/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/11/2024; 07/03/2024; 07/29/2024; 10/15/2024; 10/15/2024
• Date Device Manufactured: 05/20/2023
• 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: Hospitalization; Life Threatening; Death
• Patient Sex: Male
• Patient Weight: 73 KG