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

Model Number 105-5081-153

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

Patient Problems Obstruction/Occlusion (2422); Unspecified Nervous System Problem (4426); Swelling/ Edema (4577)

Event Date 10/06/2022

Event Type  Injury  

Event Description

Kou, w.-h., wang, x.-q., yang, j.-s., qiao, n., nie, x.-h., yu, a.-m., song, a.-x., xue, q.(2022).Endovascular treatment vs drug therapy alone in patients with mild ischemic stroke and large infarct cores. world journal of clinical cases, 10(28), 10077¿10084.Https://doi.Org/10.12998/wjcc.V10.I28.10077.  medtronic review of the literature article found a study was conducted to investigate the efficacy of endovascular treatment vs.Drug therapy alone/medical treatment in patient who had mild ischemic stroke with large infarct cores at a single healthcare facility between january 2021 and december 2021.There were 50 patients in the endovascular therapy group and 50 patients in the medical treatment group.Patients who underwent endovascular therapy treatment were noted to undergo mechanical thrombectomy in which a navien 5f 125 intermediate catheter, rebar-18 micro catheter, and solitaire ab (sab) stent retriever were used.The sab was placed thorough the micro catheter and held on for 5 min until a complete release of stent was observed.After thrombectomy, contrast examination was performed to investigate revascularization.If the thrombolysis in cerebral infarction (tici) scale score was 2b, thrombectomy could be repeated 3 times until the tici score was = 2b or equal to 3.There was no reported device malfunction/deficiency or in traoperative issue.Patients included in the medical treatment group were not treated with a medtronic device or product.  it was noted that 11 patients died in the endovascular treatment group within the 3 month follow-up period.It was additionally noted that 33 patients had poor prognosis post-operatively signified by modified rankin score (mrs)  >2.However, overall nihss score averages improved in the endovascular therapy group and only 4 patients were noted to have a neurological deterioration, which did not result in death, post-operatively.Of the 4 patients who experienced neurological deterioration, 3 were noted to have repeated vascular occlusion and 1 had tissue edema.

Manufacturer Narrative

Associated with mdr#: 2029214-2023-02122 a2.Reported patient age (51 years) is representative of the mean age of all patients included in the study article.A3.Reported patient sex (male) is representative of the majority of patients in the study group (31/50) earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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.

• 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: 18025282
• MDR Text Key: 326796436
• Report Number: 2029214-2023-02123
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093750
• 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: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 105-5081-153
• Device Catalogue Number: 105-5081-153
• 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
• Patient Outcome(s): Disability
• Patient Age: 51 YR
• Patient Sex: Male