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	Extravasation (1842); Hemorrhage/Blood Loss/Bleeding (1888); Intracranial Hemorrhage (1891); Perforation of Vessels (2135)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
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
Medtronic received a report that a solitaire patient experienced a hemorrhagic transformation.Head computer tomography (ct) without contrast was clinically significant on (b)(6) 2024.The patient did not recover/resolve.Traction bleeding could not be ruled out.A few high-density lesions in the left middle cerebral artery supply area are partially increased and partly decreased.Some contrast exudation and partial hemorrhage are considered.Patient details: mrs score 0, nihss score available: 19.The event was assessed as possibly related to the procedure.Hemorrhage post procedure complication minor injury/illness/impairment no problem detected device not returned no findings available hemorrhage/blood loss/bleeding adverse event without identified device or use problem general post-procedural complication stent.
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 reported final mtici 3.Traction bleeding cannot be ruled out.And causality assessment provided as: possible related to procedure / probable related to underlying condition or disease.The patient¿s death on (b)(6) 2024 was reported.
Event or Problem Description
Additional information received reported that the death of the subject was not related to instruments or surgery.Considering the patient¿s advanced age, potential disease condition, and potential physical condition, death may be related to the studied disease and potential disease.The patient's initial treatment was a thrombectomy of the left middle cerebral artery and the left anterior cerebral artery.This failed to reconnect several times, and intimal injury was considered.Head ct during the procedure showed the possible intimal damage and contrast exudate.Four solitaire stent retrievers had been used in the procedure, and there were no device deficiencies.No additional treatment or hospitalization was performed, and the event recovered/resolved on (b)(6) 2024.This was not a new or recurrent stroke.The patient's mrs score was 0, and their nihss score was 19.The site assessed the event as not related to the device or the disease under study and possibly related to the procedure an underlying condition.It was believed to be related to the procedure as the patient had undergone multiple thrombectomy procedures, which can lead to intimal damage.Ancillary devices include catalyst 5f and shenruida aspiration catheters.
Additional Manufacturer Narrative
Upon further review, the report of the patient death was previously reported in manufacturer reports # 2029214-2024-00717, 2029214-2 024-00718, and 2029214-2024-00719.A2: patient¿s year of birth was 1941, but the exact date is unknown.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 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 92618 ; 7635265677
• MDR Report Key: 19095862
• Report Number: 2029214-2024-00649
• Device Sequence Number: 7407979
• 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
• Report Date (Section B): 07/09/2024

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: 07/14/2026
• Device Model Number: SFR4-3-20-10
• Device Catalogue Number: SFR4-3-20-10
• Device Lot Number: B595869
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 04/17/2024; 06/14/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 05/09/2024; 07/09/2024
• Date Device Manufactured: 07/17/2023
• 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: Life Threatening; Death; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 70 KG