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); Cerebral Edema (4403)

Event Date 02/28/2024

Event Type  Injury  

Manufacturer Narrative

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

Medtronic received a report that the patient experienced superficial and deep sylvian hemorrhagic remodeling on 24 hour computerized tomography (ct).  the rationale for relating the adverse event (ae) to system or procedure was intracerebral hemorrhage, remote (rih).The patient's baseline modified rankin scale (mrs) score was 2, and baseline national institutes of health stroke scale (nihss) score was 18.The onset date was (b)(6) 2024 and the patient is recovering, and the issue resolving.The ae had a causal relationship with the disease under study.Ae not related to underlying condition or device deficiency.This event did not lead to congenital anomaly, death, disability, hospitalization, or medical intervention and was not considered life-threatening.The site assessed this event as not related to the study device or procedure.The sponsor assessed this event as possibly related to the study procedure.Additional information was received reporting the patient experienced cerebral mass effect with discrete midline deviation to the left on 24 hour computerized tomography (ct).The onset date was (b)(6) 2024 and the issue recovered/resolved on 2024-03-02.This adverse event (ae) had a causal relationship to the disease under study.Ae was not related to underlying condition or disease and did not result from a device deficiency.The patient's baseline modified rankin scale (mrs) score was 2, and baseline national institutes of health stroke scale (nihss) score was 18.Per site, this event did not lead to congenital anomaly, death, disability, hospitalization, or medical intervention, and was not considered life-threatening.The site assessed this event as not related to the study device or procedure.The sponsor assessed this event as possibly related to the study procedure.Pre-procedure mtici score 0, final post-procedure mtici score 3.

Manufacturer Narrative

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

Additional information received reported no decline in the nihss noted at 24-h post-procedure visit as baseline nihss 18, 24h fu visit (b)(6) 2024, nihss 7 and on discharge (b)(6)2024 nihss 1.

• 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: 18980571
• MDR Text Key: 338659908
• Report Number: 2029214-2024-00512
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K180715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

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: B429851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/08/2024
• Date Device Manufactured: 08/11/2022
• 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): Other
• Patient Sex: Female
• Patient Weight: 39 KG