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 Intracranial Hemorrhage (1891); Perforation (2001); Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Vascular Dissection (3160); Embolism/Embolus (4438)

Event Date 10/21/2022

Event Type  Injury  

Manufacturer Narrative

Please see attachments for literature article.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

M.Webb, m.Amir essibayi, s.Al kasab, i.L.Maier, m.Psychogios, j.Grossberg, a.Alawieh, s.Wolfe, a.Arthur, t.Dumont, p.Kan, j.Kim, r.De leacy, j.Osbun, a.Rai, p.Jabbour, j.Mascitelli; journal of neurosurgery; 2023; 93:1168¿1179; predictors of angiographic outcome after failed thrombectomy for large vessel occlusion: insights from the stroke thrombectomy and aneurysm registry; d oi.Org/10.1227/neu.0000000000002560 medtronic received information that patient treated with medtronic devices to preform mechanical thrombectomy (mt) for large vessel occlusion (lvo) had complications.The study sought to investigate patient and treatment characteristics that predict mechanical thrombectomy failure (mtf).  this was a retrospective review of the prospectively collected, multicenter, multinational stroke thrombectomy and aneurysm registry (star).Patients, aged 18 years or older, from 32 comprehensive stroke centers who underwent mt for anterior or posterior circulation lvo between january 2015 and december 2021.Patients were categorized by mts or mtf, defined as mtici 2b or greater and less than mtici 2b, respectively.Outcome measures included complications, symptomatic intracerebral hemorrhage (sich; defined as postprocedural hemorrhage with associated decrease =4 on the nihss), postoperative nihss, discharge and 90- day nihss, length of stay, discharge mrs, and 90-day mrs.Favorable outcome was defined as mrs score of 0 to 2 at 90 days. a total of 6780 patients were included in the anterior circulation lvo analysis, of which 1001 (15%) experienced mtf.Outcomes: there was one mt failure with a patient treated with a riptide aspritation device with 12 successful.There was one mt failure with a patient treated with a react catheter with 33 successful.There was 39 mt failures of patient treated with soliatire devices with 283 successful.And there was 305 mt failures of patients treated with solumbra soliatire devices with 1975 successful.Specific complications and symptoms were not identified.  ooverall complications included contrast exrtavasation (7 mtf, 21 mts), distal embolization (297 mtf, 1322 mts), dissections (17 mtf, 48 mts) perforation (114 mtf, 644 mts), symptomatic intracerebral hemorrhage (sich) (84 mtf, 329 mts), and more mtf patients required craniectomies (10% vs 2.8%).Favorable outcomes were greater in the mts group (43% vs 18%).

• 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: 19076502
• MDR Text Key: 339773981
• Report Number: 2029214-2024-00616
• 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: Other
• Type of Report: Initial
• Report Date: 04/09/2024

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2024
• 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: 73 YR