MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REBAR; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-REBAR

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

Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Muscle Weakness (1967); Numbness (2415); Thrombosis/Thrombus (4440)

Event Date 03/24/2023

Event Type  Injury  

Manufacturer Narrative

Li z, wu s, zhao s, et al.Successful mechanical thrombectomy in acute bilateral m1 middle cerebral artery occlusion: a case report and literature review.Bmc neurology.2023;23(1):119.Doi:10.1186/s12883-023-03173-y.See manufacturer report#: 2029214-2023-02111 for another report from this article.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.

Event Description

Li z, wu s, zhao s, et al.Successful mechanical thrombectomy in acute bilateral m1 middle cerebral artery occlusion: a case report and literature review.Bmc neurology.2023;23(1):119.Doi:10.1186/s12883-023-03173-y.Medtronic literature review found a report of patient complications in association with a navien catheter, rebar catheter, and solitaire fr stent retriever.The purpose of this article was to report a case of acute unilateral middle cerebral artery (mca) occlusion with sequential acute occlusion of the bilateral mca during intravenous thrombolysis (ivt).The article does not state any technical issues during use of the navien, rebar, or solitaire.A thrombectomy was performed using the solitaire stent retriever and the navien and rebar catheters, and a large amount of thrombosis was removed.Angiography showed that the blood flow of the main branch of the right mca was not obstructed with mtici grade 3.The same method was then used to remove the left mca m1 thrombosis.Angiography showed recanalization of the trunk and branches of the left mca with mtici grade 3.On the second day after the operation, the patient regained consciousness and was accompanied by motor aphasia.Their right limb muscle strength was level 5, and their left limb muscle strength was level 2 with sensory loss of the left limb.Brain ct showed a small amount of bleeding in the right basal ganglia.Brain magnetic resonance imaging (mri) showed a new cerebral infarction in the bilateral basal ganglia and bilateral cortex.Pathological examination of bilateral thrombosis showed mixed thrombosis.The patient has been followed up at the local hospital postoperatively and their mrs score was 2 at a 90-day telephone follow-up.

• Brand Name: REBAR
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 18017018
• MDR Text Key: 326675644
• Report Number: 2029214-2023-02112
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-REBAR
• Device Catalogue Number: UNK-NV-REBAR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2023
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male