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 Problems Vasoconstriction (2126); Nervous System Injury (2689); Hemorrhagic Stroke (4417); Embolism/Embolus (4438)

Event Date 11/26/2023

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 developed complex neurological symptoms post-operative, resulting in multiple investigations and tests that found polymer emboli in the brain.Symptoms presented over the days, weeks, and months post-operative similarly to vasculitis and multiple tests and investigations were completed before finally doing a brain biopsy.Treatment was steroids, immunotherapy and other not made known to the manufacturer representative (rep) due to confidentiality.The patient is alive with injury.The patient suffered cerebral hemispherical hydrophilic polymer embolism/emboli after several months unwell in and out of hospital requiring steroids, brain biopsy (which confirmed polymer emboli) and will require several years of immunotherapy and steroids to manage condition.The device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.The access vessel was the internal carotid artery (ica).Ancillary devices include a stryker excelsior sl-10 st 2 tip (lot: 24089060) microcatheter, terumo glide cath 5fr (lot: 230713) micr ocatheter.

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

Additional information received reported the patient remains unwell, with ongoing medical care required.The patient had symptoms of stroke, vasospasm, and other non-specific neurological symptoms.The cause of the issue was not determined, but the customer assumes one of the catheters polymer jackets was compromised during the procedure.

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.

• 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: 18851129
• MDR Text Key: 337069953
• Report Number: 2029214-2024-00382
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2024

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: 105-5081-153
• Device Catalogue Number: 105-5081-153
• Device Lot Number: B576462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 03/24/2024; 03/24/2024
• Supplement Dates FDA Received: 04/12/2024; 04/12/2024
• Date Device Manufactured: 06/08/2023
• 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): Hospitalization; Required Intervention; Disability
• Patient Sex: Female