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 Hemorrhagic Stroke (4417); Unspecified Nervous System Problem (4426)

Event Date 02/23/2024

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

Medtronic received a report that the patient experienced a hemorrhagic transformation stroke ph2 post procedure on (b)(6) 2024.The event was not a recurrent or new stroke.The patient was given morphine and digoxin.The mrs score was 0 and nihss score was 22.Pre-procedure mtici was 0 and post procedure was 2c.The outcome of the event was fatal on (b)(6) 2024.It was noted that the event was probably related to the disease under study and not related to an underlying disease or condition.The event didn't result from a device deficiency.The sponsor and the site assessed the event as possibly related to the study procedure.The rationale for relating to the procedure was that hemorrhagic transformation could result from recanalization procedure or be a spontaneous complication of ischemic stroke.Additional information has been received reporting the vessel tortuosity was unknown.Baseline national institutes of health stroke scale (nihss) 22; 24 hour follow up nihss 28.It was not collected in the study where the patient passed away, however, site has completed the exit crf with the subject status subject death.It was not collected in the study therefore "not applicable" if autopsy records be available.Subject was admitted for index stroke treatment, event led to prolongation of existing hospitalization with fatal outcome.The cause of the event was possibly related to the study procedure, probably related to the disease under study.This information was confirmed with the physician/account.

• 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: 19064512
• MDR Text Key: 339636678
• Report Number: 2029214-2024-00600
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• 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
• Date Manufacturer Received: 03/29/2024
• 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: 90 YR
• Patient Sex: Female
• Patient Weight: 85 KG