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 Hemorrhage/Bleeding (1888); Vasoconstriction (2126); Vascular Dissection (3160); Insufficient Information (4580)

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

Event related to literature article 2029214-2022-01129.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

Vu dang luu, le hoang kien, tran anh tuan, nguyen quang anh, nguyen tat thien, nguyen thu trang, dao viet phuong, mai duy ton, pham minh thong, le chi cong, vu van trieu, nguyen tien manh, tran cuong; asian journal of neurosurgery; 2022; volume 15: issue 2; safety and efficacy of a direct aspiration first-pass technique with large-bore catheters for acute ischemic stroke in vietnam: experience of a single center; 10.4103/ajns.Ajns_263_19.Medtronic received information in a literature article that patients treated with rebar 2.7f catheters had complications. the purpose of this study was to evaluate the safety and efficacy of mechanical thrombectomy with a direct aspiration first-pass technique (adapt) using large-bore catheters in patients with acute ischemic stroke due to large vessel occlusion (lvo). during the study period (from january 2017 to june 2018), the records of86 patients with acute lvo and treated with thrombectomy intervention using adapt were obtained, and 73 patients (35 females) met study criteria.Median age was 61.29 years.  procedures were performed with an 8f guide catheter with or without an intermediate catheter.For aspiration, ace 64 or ace 68 reperfusion catheters were advanced to the blood clot with the help of a microcatheter (rebar 2.7f) and micro guidewire (transcend 0.014¿).When an intracranial stent was required, antiplatelet therapy is used in the acute phase.If an intracranial stent was placed and there was no hemorrhagic complication on the study imaging, patients were started on dual antiplatelet therapy with aspirin 81 mg/day and clopidogrel 75 mg/day for 3 months and aspirin 81 mg/day for life.Successful recanalization post-adapt (thrombolysis in cerebral infarction 2b-3) was achieved in 72.6% (53/73) of patients.Good func tional outcome (modified rankin scale 0¿2) at 3 months was achieved in 50.7% (37/73), with poor functional outcome in 24.7% (18/73).The 90-day mortality rate was 24.7% (18/73).The hemorrhagic transformation rate was 31.6%, in which 19.2% were symptomatic.Vessel perforation occurred in 5.5% (4/73) of patients but in all cases was associated with the guidewire and not the reperfusion catheter.Vessel dissection occurred in 1.4% (1/73) and vasospasm in 5.5% (4/73) of patients.

• 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: 14951860
• MDR Text Key: 295476980
• Report Number: 2029214-2022-01130
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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: Other
• Type of Report: Initial
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• 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
• Date Manufacturer Received: 06/13/2022
• 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): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male