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

Model Number FG15150-0615-1S

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

Patient Problems Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Paralysis (1997); Swelling/ Edema (4577)

Event Date 03/15/2022

Event Type  Injury  

Manufacturer Narrative

See manufacturer report # 2029214-2022-00558 for the pipeline involved in this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that a pipeline patient experienced hemiparesis following the procedure.The patient was undergoing treatment for an unruptured, recurrent neck aneurysm located in the right anterior communicating artery that had been previously coiled aneurysm.The patient was known to have fibromuscular dysplasia (fmd) in the proximal internal carotid artery.The max diameter was 2.75mm, and the neck diameter was 3.5mm.The patient's vessel tortuosity was severe.The landing zone was 2.7mm distal and 2.5mm proximal. dual antiplatelet treatment was administered.It was reported that the patient was treated with verapamil due to the proximal fmd.The pipeline was placed without incident or technical difficulties.However, upon follow up the next day, the patient was unable to move their left arm and also had some hyperperfusion.The doctor suspected that a response to the use of the pipeline or the hydrophilic coating of the phenom 27 microcatheter may have caused the issue.The doctor had seen this previously, with extravasation of fluid and swelling from the parent treated vessel directly distal to the placement of the pipeline 3-13 hours following implant.In all cases the patients recovered with no neurological deficits.A balloon was not used in the procedure.The doctor stated that diffusion imaging can show contact agent outside the lumen of the vessel.Other possible causes considered were the duration of the cases, use of too much contrast, and that the use of verapamil in a diseased vessel could induce fluid extravasation in some cases.No conclusive conclusion was determined. it was noted that the device was being used off-label as it was placed in the anterior communicating artery. angiographic results post procedure showed the device was well apposed throughout its length, and there was no endoleak. the devices were prepared according to the instructions for use (ifu).

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

Additional information received reported that the patient was discharged after returning to baseline.There were no known further ac tions/interventions taken to resolve the event.

• Brand Name: CATHERA
• 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: 13984772
• MDR Text Key: 291634261
• Report Number: 2029214-2022-00559
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: 222416271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2022
• Date Device Manufactured: 06/23/2021
• 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 Age: 63 YR
• Patient Sex: Female