MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REBAR; CATHETER, CONTINUOUS FLUSH

Model Number 105-5081-153

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

Patient Problem Ischemia Stroke (4418)

Event Date 10/25/2023

Event Type  Death  

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

Masthoff, m., krähling, h., akkurt, b.H., elsharkawy, m., köhler, m., ergawy, m., thomas, c., schwindt, w., minnerup, j., & stracke, p.(2023).Evaluation of effectiveness and safety of the multizone nevatm stent retriever for mechanical thrombectomy in ischemic stroke.Neuroradiology: a journal dedicated to neuroimaging and interventional neuroradiology, 65(12), 1777¿1785.Https://doi.Org/10.1007/s00234-023-03236-4.Medtronic review of the literature article found a study of 39 patients who underwent thrombectomy procedures to treat ischemic stroke between march and november 2022.The study was mainly evaluating the safety and efficacy of a non-medtronic stent retriever.However, it was noted that react-68 aspiration catheters and rebar-18 microcatheter were used in the procedures.No device malfunctions were reported.Technical success of recanalization, defined as achieving a mtici 2b or higher, was achieved in 37/39 cases.The article reported there were no minor or major adverse events were observed in the study cohort.However, the following post-operative adverse events were noted: there were 4 patient in-hospital patient mortalities.It was noted that none of the patient deaths were device associated.

• Brand Name: REBAR
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 19055405
• MDR Text Key: 339547474
• Report Number: 2029214-2024-00587
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093750
• 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: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 105-5081-153
• Device Catalogue Number: 105-5081-153
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• 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): Death
• Patient Age: 69 YR
• Patient Sex: Female