MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PHENOM

Model Number UNK-NV-FG

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

Patient Problems Stroke/CVA (1770); Thromboembolism (2654)

Event Date 02/28/2022

Event Type  Injury  

Manufacturer Narrative

Event related to regulatory reports: 2029214-2022-00765 and 2029214-2022-00764.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 solitaire sfr4 stent and a react-68 catheter were involved in an event with thrombus migration and infarct in new vascular territory.Location of proximal face of clot 1: location: middle cerebral artery (mca), m2 hemisphere: left.Pre-procedure mtici score: 2a.Final post-procedure mtici score: 2b.The access vessel was the femoral.Thrombus migration distal in the treated vascular territory.Final mrs score: 2.Nihss score: 19. discharge imaging crf dated 24 mar 2022 indicates "infarct in new vascular territory".Deemed serious procedure related event with rs5 at discharge.No actions were taken.The event is not resolved.Additional information received reported the patient's pre-procedure nihss was 19 and post-procedure nihss was 20.Nihss had improved to 13 at time of patient's discharge.Additional information received reported it was adjudicated the event is causal relationship to procedure, possible to react, solitaire, and phenom 21.Distal cerebral artery embolism in the treated vascular territory.

• Brand Name: PHENOM
• 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: 15142424
• MDR Text Key: 297039099
• Report Number: 2029214-2022-01286
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• 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
• Date Manufacturer Received: 07/21/2022
• 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: 85 YR
• Patient Sex: Male
• Patient Weight: 85 KG