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 Intracranial Hemorrhage (1891); Unspecified Nervous System Problem (4426)

Event Date 12/26/2023

Event Type  Injury  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the patient experienced distal embolization to a new vascular territory during the procedure  which was performed on (b)(6) 2023.Subarachnoid hemorrhage (sah) and intraventricular hemorrhage (ivh) were observed on computerized tom ography (ct) 24 hours post procedure.It was unknown if an assessment for product/therapy/procedure relatedness was made by the investigator, sponsor, or cec.Additional information was received reporting the previously reported potential complaint of "distal embolization to a new vascular territory during the procedure" was verified by the site, and the data has been updated for the question "was there embolization to a new vascular territory during the procedure" as "no".Further information regarding sah and ivh was unknown, since queries were placed in the database for site to report these observations as adverse events.Medtronic received a report that this sah occurred after the procedure, so it cannot be said to be unrelated, but due to mild symptoms, the patient was discharged after observation without any special treatments.This adverse event (ae) was not related to the disease under study or an underlying condition or disease.This ae did not result from a device deficiency.This was revealed at the 6 hour post follow up computerized tomography (ct) test but there was no further action.Modified rankin scale (mrs) score 0, national institutes of health stroke scale (nihss) 9.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 possibly related to the study devices and procedure.The sponsor assessed that the sah ae was causally related to the study procedure and possibly related to the study devices utilized (solitaire, react, and phenom.) pre-procedure mtici score indeterminate, final post-procedure mtici score 3.The pat ient recovered/resolved with sequelae on (b)(6) 2023.Additional information was received reporting the mrs at discharge was 2 and subject pre morbid mrs was 0.

• 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: 18726912
• MDR Text Key: 335743015
• Report Number: 2029214-2024-00308
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 02/16/2024

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: 02/15/2024
• Initial Date FDA Received: 02/16/2024
• 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): Disability
• Patient Age: 77 YR
• Patient Sex: Male