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

Model Number UNK-NV-FG

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

Patient Problems Ischemia (1942); Ischemia Stroke (4418)

Event Date 11/11/2023

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 stroke, retinal ischemia with an onset date of (b)(6) 2023.The patient is recovering/resolving.This adverse event (ae) did not result in any treatment, hospitalization, blood transfusion, or surgical/percutaneous intervention.This event resulted in new or worsening of existing neurological deficits.Symptoms lasted more than 24 hours.The site assessed this event did not lead to congenital anomaly, death, disability, hospitalizations, or medical intervention and was not considered life-threatening.Additional information was received reporting medtronic safety representative assessed this event as possibly related to the procedure, device and antiplatelet therapy.Per safety assessment this event was possibly caused by or related to the patient index condition.It is unknown if this event was caused by or related to an underlying patient condition.No additional intervention or additional treatment required to address the adverse events was reported by the site.Non-sae per site reported data on rdc.The patient was undergoing surgery for treatment of a saccular, sidewall left internal carotid artery (ica) c4 aneurysm with a max diameter of 5.2mm and a 4.7mm neck diameter.The dome height was 8.3mm, dome width 5.2mm.Parent artery diameter distal to aneurysm was 3.8mm.Parent artery diameter proximal to aneurysm was 4.2mm.The access vessel was the right femoral.There was no stasis at the end of the procedure.There was complete neck coverage at the end of the procedure.Aneurysm occlusion (raymond and roy) at the end of the procedure was class 3.

• Brand Name: PHENOM
• 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: 19033134
• MDR Text Key: 339254405
• Report Number: 2029214-2024-00562
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2024

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: UNK-NV-FG
• Device Catalogue Number: UNK-NV-FG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/03/2024
• 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): Other
• Patient Sex: Female
• Patient Weight: 64 KG