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); Pseudoaneurysm (2605)
Date of Event	03/28/2024
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 information that a patient treated in the solitaire study had complications.The site indicated that an intraventricular hemorrhage was seen on 24-hour post index procedure imaging on (b)(6) 2024.The site has been queried to enter an adverse event to capture additional information as this could be related to the study procedure and study devices utilized.Additional information was received reporting the patient was admitted to the neurosurgical intensive care unit for continued treatment from (b)(6) 2024 and was still in a coma when the email was sent.Postoperative head ct showed that the left frontotemporal cerebral hemorrhage.The cause of the hemorrhage was not determined.
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 event was not related to the patient index condition.The event was possibly related to the patient condition.The event may be related to the thrombectomy/index-procedure.The event was not related to the medtronic devices used.Additional intervention or additional treatment was required to address the adverse events, specifically the removal of the intracerebral hematoma.The event led to serious deterioration in the health of the subject, as defined by: in-patient or prolonged hospitalization.Additional information received that after the procedure, crossover superselective imaging of the right iliac artery showed pseudoaneurysm formation in the right femoral artery.No treatment was noted.

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19372174
• Report Number: 2029214-2024-00958
• Device Sequence Number: 7538074
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/18/2024
• 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: Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male