MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SOLITAIRE FR3; CATHETER, THROMBUS RETRIEVER

Model Number SFR3-6-40-10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Vascular Dissection (3160); Ischemia Stroke (4418)

Event Date 09/01/2022

Event Type  Death  

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 Description

Medtronic received information that a patient treated with a solitaire stent had a cerebral infarction with mild obstructive hydrops which led to death on (b)(6) 2022.On (b)(6) 2022 the patient underwent interventional surgery, (b)(6) 2022 the patient underwent interventional surgery, postoperative drug sedation state, ventilator assisted ventilation, after drug withdrawal.Nihss score: 5, mrs score: 5.The event was not related to the device or procedure. related to disease under study - index stroke.The patient was being treated for a clot in the midline basilar artery. pre-procedure mtici score: 0.Final post-procedure mtici score: 2b.Additional information received reported that no actions/interventions were taken to resolve the cerebral infarction.The patient died at the treating hospital.The death was not related to any medtronic device per the site and sponsor.At baseline mrs 5, etiology of stroke was large artery atherosclerosis - intracranial atherosclerosis with suspected local thrombosis.Additional information was received that on 2022-sep-01, the patient was in a coma after drug withdrawal.The patient's family decided to stop ventilator assisted ventilation, and the patient had respiratory and cardiac arrest and died clinically.The event remains a non-complaint as it was asses sed as not related to the medtronic device/procedure.Additioanl information received reported it was adjudicated event stroke in evolution, possible procedure related as commented postoperative ct.There is stagnated contrast at the site of the pta of ba stenosis indicating potential dissection.

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.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 Description

Medtronic received information that a patient treated with a solitaire sfr3 stent had bleeding.Post-operative ct examination showed a new high-density image in the right occipital lobe.Contrast agent exudation with bleeding was considered.No actions or treatment was given.Nihss score: 5, mrs score: 0.The event resolved on 2023-aug-30.The event was possibly related to the procedure and devices used.Location of proximal face of clot 1: location: basilar artery.Hemisphere: midline.Pre-procedure mtici score: 0.Final post-procedure mtici score: 2b.

• Brand Name: SOLITAIRE FR3
• Type of Device: 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: 18402441
• MDR Text Key: 331437504
• Report Number: 2029214-2023-02476
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00847536034792
• UDI-Public: 00847536034792
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K181186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2023
• Device Model Number: SFR3-6-40-10
• Device Catalogue Number: SFR3-6-40-10
• Device Lot Number: B231220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/29/2024
• Date Device Manufactured: 07/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male
• Patient Weight: 73 KG