MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REACT CATHETER; CATHETER, PERCUTANEOUS

Model Number REACT-68

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

Patient Problems Hematoma (1884); Intracranial Hemorrhage (1891); Perforation of Vessels (2135); Pseudoaneurysm (2605); Vascular Dissection (3160); Embolism/Embolus (4438)

Event Date 04/01/2021

Event Type  Injury  

Event Description

Cortez gm, turner rd, monteiro a, et al.Walrus large bore guide catheter impact on recanalization first pass effect and outcomes: the wicked study.Journal of neurointerventional surgery.2022;14(3):280-285.Doi:10.1136/neurintsurg-2021-017494.Medtronic literature review found reported of mortality, intracranial cerebral hemorrhage, embolisms, vessel dissection, vessel perforation, and groin hematomas in association with the react catheters used during thrombectomy.The purpose of this article was to investigate the performance and safety of the walrus balloon guide catheter in the recanalization of emergent large vessel occlusions.The authors reviewed 338 cases of patients treated for emergent large vessel occlusions using the walrus balloon guide catheter and 22 different catheters were used in different cases including the react71 catheter (used in 36/338 cases) and react 68 catheter.Of the 338 patients, the average age was 68.3 years, 178 were female and 160 were male.One-hundred and twenty-six patients received intravenous alteplase/ tissue plasminogen activator (tpa) prior to the thrombectomy.The article does not state any technical issues during use of the react catheter.In addition, 223 patients baseline mrs score was 0, 38 patient baseline mrs score was 1, 31 patients baseline mrs score was 2, 26 patients baseline mrs score was 3, 10 patients baseline mrs score was 4, and 1 patient's baseline mrs score was 5.The average baseline nihss score was 15 with a range of 11-21.Post procedure tici scores were: 159 patients tici score was 3, 68 patients tici score was 2c, 92 patients tici score was 2b, 13 patients tici score was 2a, 1 patient tici score was 1, and 5 patients tici score was 0.Post procedure average nihss score was 5 with a range of 2-14.  the following intra- or post-procedural outcomes were noted: mortality occurred in 63/252 cases intracranial cerebral hemorrhage occurred in 13 cases emboli to new territory/downstream emboli occurred in 12 cases vessel dissection occurred in 4 patients vessel perforation occurred in 2 patients groin hematoma/pseudoaneurysm occurred in 5 patients.

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.

• Brand Name: REACT CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 16743712
• MDR Text Key: 313348235
• Report Number: 2029214-2023-00640
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2023

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 Model Number: REACT-68
• Device Catalogue Number: REACT-68
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 04/14/2023
• 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