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 Foreign Body Reaction (1868); Headache (1880); Intracranial Hemorrhage (1891); Nausea (1970); Dizziness (2194); Embolism/Embolus (4438)

Event Date 12/16/2022

Event Type  Injury  

Manufacturer Narrative

See manufacturer report # 2029214-2023-00344 for another device used in this event.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 information that a patient treated with 2 ped3 pipeline flow diverters, a navien support catheter, a hyperguide balloon, and a phenom catheter had symptoms of distal embolization which were diagnosed type of polymeric embolization.Patient had severe symptoms which required corticosteroids.The devices were prepared as indicated in the instructions for use (ifu).The patient was undergoing flow diverter treatment.Dual antiplatelet therapy was administered.Angiographic result post procedure was good.  ancillary devices: penubra neuron max sheath, synchro select guidewire additional information received reported that the patient recovered from the subarachnoid hemorrhage (sah) very well and was discharged (b)(6) 2023 without deficits, only a slight headache.They returned back to the ed on (b)(6) 2023 due to progressing headache, vertigo and nausea without neurologic deficits.The patient was given dexamethason 4mg x3 from (b)(6) 2023, and at the moment dose decreased to 4mg x2.The patient was undergoing treatment for a lesion located in the right supratentorial (frontal, temporal, parietal, occipital lobes) multifocal areas of vasogenic edema with microhemorrhages and scattered enhancement.It was initially a ruptured right m1 fusiformic aneurysm.

• 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: 16424056
• MDR Text Key: 310050059
• Report Number: 2029214-2023-00345
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536041868
• UDI-Public: 00847536041868
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K151638
• 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
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• 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: OC21-058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Date Device Manufactured: 10/28/2021
• 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): Required Intervention
• Patient Sex: Female