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

Model Number REACT-71

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

Patient Problems Intracranial Hemorrhage (1891); Perforation (2001)

Event Date 02/02/2022

Event Type  Death  

Manufacturer Narrative

Event related to regulatory report: 2029214-2023-00642.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

Requena, piñana, olive-gadea, hernández, boned, de dios, rodrigo, rivera, muchada, luis cuevas, rubiera, garcía-tornel, ludovica gramegna, molina, ribo, and tomasello; interventional neuroradiology; 2022; 1¿6; combined technique as first approach in mechanical thrombectomy: efficacy and safety of react catheter combined with stent retriever; doi: 10.1177/15910199221095798 journals.Medtronic received information that patients treated with react 68 and 71 catheter and possibly solitaire stent had complications. the purpose of the article was to evaluate the effectiveness and safety of the react aspiration catheter used with a stent retriever.The prospective study included consecutive adult patients who underwent mechanical thrombectomy (mt) with acombined technique using react 68 and/or 71 between june 2020 and july 2021.During the inclusion period, 102 patients underwent mt with the combined technique using react catheters.The mean patient age was 78 years, 50.0% (51/102) patients were female.Methods: through a percutaneous transfemoral or transradial approach, a long 6f sheath was placed in the internal carotid artery (ica) or vertebral artery.The triaxial system was completed with the introduction of a react catheter (react 71 or 68 was selected at the discretion of the interventionalist) and a 0.021-inch microcatheter with a 0.014-inch microwire.The microcatheter was then advanced through the occlusion site, and the stent retriever (sr).Once the sr was deployed, and the system was anchored, the react catheter was advanced to the clot position under distal aspiration with a manual or pump aspiration system initiated at the moment of catheter-clot contact.In most cases, the sr and the react catheter were completely removed from both guide catheter and long sheath under continuous aspiration.However, the solumbra technique (removing the sr without removing the aspiration catheter if it is not occluded) was preferred by one of the interventionalist and when distal access was laborious.Of the included patients, 47 fulfilled class i-a indication based on current guidelines.React 71 was used in 77.5% (79/102) of patients and react 68 in the remaining 22.5% (23/102).Different stent retrievers were used, including solitaire-x.Outcomes: median procedural time from arterial puncture to recanalization was 40 minutes, and the median number of passes was 2.With the anchoring effect of the stent retriever and the support of guide catheters, react could be tracked into the desired position in all patients in our series.Successful recanalization (mtici 2b-3) was achieved in 89.2% (91/102) of patients with a rate of complete recanalization (mtici 2c-3) of 64.7% (66/102).Successful recanalization was achieved in a single attempt in 55 (53.9%) patients and complete recanalization in 36.3% (37/102).The rate of sudden recanalization was 71.6% (73/102); in 50.0% (51/102) of patients, mtici scores progressed from 0¿1 to 2c-3 in a single pass.In all patient's procedural complications occurred in 3.9% (4/102) of patients.All four patients showed extravasation of contrast due to arterial perforation related to microcatheterization; two were asymptomatic and two had a worsening of the 24 h nihss score =4.The rate of symptomatic intracranial hemorrhage (sich) was 6.8% (7/102), and 13 (12.7%) patients died during hospital admission.

• 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: 16747571
• MDR Text Key: 313389287
• Report Number: 2029214-2023-00643
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K182097
• 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: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: REACT-71
• Device Catalogue Number: REACT-71
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2023
• 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): Death
• Patient Age: 78 DA