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 Problem Vasoconstriction (2126)

Event Date 04/12/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the patient experienced spasm during the procedure.This was treated with nimotopp 10ml in the left proximal middle cerebral artery (mca), and resolved the same day. the event was not the result of a device deficiency.It was possible mechanical irritation resulted in the vasospasms.The event did not result in hospitalization, disability, or medical intervention.The event was assessed as possibly related to the device and procedure, and not related to the disease under study.The patient was undergoing a mechanical thrombectomy for a clot located in the m2 segment of the left mca.The patient's pre-procedure mtici score was 0, and post-procedure it was 2b.The patient's mrs score was 0, and their nihss score was 12.Ancillary devices include a react 68, sofia plus catheter, and a neva t-35 stent retriever.

• 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12084577
• MDR Text Key: 258931668
• Report Number: 2029214-2021-00784
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K180715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2021

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 Expiration Date: 09/18/2022
• Device Model Number: REACT-68
• Device Catalogue Number: REACT-68
• Device Lot Number: B090731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 06/29/2021
• Date Device Manufactured: 09/23/2020
• 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: 60 YR
• Patient Weight: 63