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 Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Insufficient Information (4580)

Event Date 09/26/2022

Event Type  Injury  

Manufacturer Narrative

Gong y, wang j.Effect of standardized perioperative management on eeg indexes and nerve and limb functions of patients with acute cerebral infarction undergoing mechanical thrombectomy.Disease markers.2022;2022:1686891.Doi:10.1155/2022/1686891.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

Gong y, wang j.Effect of standardized perioperative management on eeg indexes and nerve and limb functions of patients with acute cerebral infarction undergoing mechanical thrombectomy.Disease markers.2022;2022:1686891.Doi:10.1155/2022/1686891.Medtronic literature review found a report of patient complications in association with solitaire ab stent and rebar18 microcatheter.The purpose of this article was to explore the application value of standardized perioperative management in mechanical thrombectomy for acute cerebral infarction.98 patients with acute cerebral infarction admitted from january 2019 to january 2022 were selected as the study sample in this study, and all patients were given the standardized perioperative management.According to the interventional methods, they were divided into the thrombolytic treatment group (arteriovenous combined thrombolysis, n = 49) and mechanical thrombectomy group (mechanical thrombectomy, n = 49) to compare the nerve function, limb function, thrombolysis in myocardial infarction (timi) flow grade, symptomatic intracranial hemorrhage within 24 hours, acute vascular reocclusion, and the death status within 1 year and incidence of adverse events in 90 days of the two groups after treatment.The average age was 68 years and the majority of patients were male.  for arteriovenous combined thrombolysis, 0.9% of sodium chloride injection at a dose of 100 ml added to urokinase (100 × 104 u) was used completely by intravenous drip within 30 min.The thrombolytic steps were as follows.1% of lidocaine at a dose of 10 ml was used for the local anesthesia of patients, and the right femoral artery was punctured using the modified sedingger technique, with an inserted 6 f arterial catheter.Heparin (3000 u) was used by a drip chamber putted into the 6 f guiding catheter under the guidance of the guide wire, and the head end was sent to the pathological artery, vertebral artery, or carotid artery.The site of artery stenosis, stenosis degree, and case of collateral compensation were shown by photography.The head of microwire or trensend microtubule was send to the distal thrombus according to the path graph, and the urokinase (10 × 104 u) was given from the microtubule at 10 × 103 u/min via pump.The head of catheter was inserted in thrombus by withdrawing, with the urokinase (10 × 104 u) by injection.The catheter was withdrawn to the proximal thrombus, with the urokinase (10 × 104 u) by injection, and the photography was performed 1time/10 min.For mechanical thrombectomy, 1% of lidocaine at a dose of 10 ml was used for the local anesthesia, and the right femoral artery of patients was punctured using the modified sedingger technique, with an inserted 6 f arterial catheter.Heparin (3000 u) was used by a drip chamber putted into the 6 f guiding catheter under the guidance of the guide wire, and the head end was sent to the pathologic artery, vertebral artery, or carotid artery.The site of artery stenosis, stenosis degree, and case of collateral compensation were shown by photography.Under the roadmap, the rebar18 microcatheter stent was sent to the delivery system under the guidance of silver-speed-14 micro-wire or pt wire, and the head of the rebar catheter was sent to the thrombus.Solitaire ab stent (4-20 mm) was sent from rebar, with the retracement of rebar and the release of stent.The stent was withdrawn after photography, and the thrombus th at has been extracted was checked, while 30 m1 of blood in the guiding catheter was abstracted.The images were shown using photography after taking the thrombus in order to prevent the fallen thrombus into the cerebral artery again with the blood flow.The arteri al catheter was removed, the vascular closure device in abbott was used for hemostasis, and the puncture point was bandaged.The article does not state any technical issues during use of the solitaire ab or rebar18.The following intra- or post-procedural outcomes were noted: -there were 2 cases with symptomatic intracranial hemorrhage within 24 hours, and 4 cases with acute vascular reocclusion.-1 case of gingiva bleeding, 1 case of hemorrhinia, and 2 cases of recurrent cerebral infarction in 90 days, with a total of 4 cases (8.16%) in the mechanical thrombectomy group.

• 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: 18026341
• MDR Text Key: 326797949
• Report Number: 2029214-2023-02125
• 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): Other
• Patient Sex: Male