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 Stroke/CVA (1770); Embolism/Embolus (4438)

Event Date 12/12/2021

Event Type  Injury  

Manufacturer Narrative

Event related to regulatory reports: 2029214-2022-00012.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 a cerebral artery embolism in the same vascular territory during a solitaire procedure.There was a distal embolization from the left proximal posterior cerebral artery (pca) to downstream pca after aspiration thrombectomy with the react 68 catheter.As a result, the patient was hospitalized until (b)(6) 2021 and another surgical procedure was performed.The event was noted to have resolved on (b)(6) 2021.The event was not the result a device deficiency, and there was no new or recurrent stroke.The patient's mrs score was 0, and their nihss score was 34.The event was assessed as possibly related to an underlying cause, not related to the solitaire, and caused by the disease under study, the procedure, and the catheter.The patient was undergoing treatment for three clots in the midline basilar artery, and one clot in the p1 segment of the left pca.The patient's final post-procedure mtici score was 3.Additional information received reported during procedure, reason for strategy change after pass #1 and 2 was described as "unsuccessful thrombectomy".Site was queried to provide reason for this.(pass number: 3; reason for strategy change: new embolus, this event was reported previously.) post-procedure ct on (b)(6) 2021 showed expansion of index infarct.The patient had a mechanical thrombectomy.The access vessel was the femoral.The patient was being treated for an ischemic stroke.The location was the basilar artery.* mrs: baseline 0.* mrs: procedure 5.* nihss score: baseline 34.* nihss score: post procedure 18.* tici score: baseline 1.* tici score: post procedure 3.4 passes with the device.Iv tpa was contraindicated.Additional information was received indicating the pre-procedure mtici score was 0 of the first clot.The third clot had a pre-procedure mtici score of 1.The fourth clot had a pre-procedure mtici score of 2b.Additional information received reported it was adjudicated the event as non-serious, causally related to the study procedure, and possibly related to react, solitaire, and phenom microcatheter.

• 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: 18005715
• MDR Text Key: 326523341
• Report Number: 2029214-2023-02083
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 10/25/2023

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: 09/29/2023
• Initial Date FDA Received: 10/25/2023
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 50 KG