MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number COREVALVE EVOLUTPRO+ & ENVEO SYSTEM (23MM, 26MM, 29MM, & 34MM)

Device Problem Insufficient Information (3190)

Patient Problem Transient Ischemic Attack (2109)

Event Date 11/06/2022

Event Type  Injury  

Manufacturer Narrative

Tvt registry exemption number: e2014038 quarterly reporting period: q4 2022 total number of events being summarized: 44 under the terms and conditions of the registry, anonymized patient demographics details and limited details were provided regarding the adverse events and outcomes.The listed event date is the date the information was received by medtronic.Is an average of the data provided for the events.A product analysis was not able to be performed as no product was returned.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.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

The type of serious injuries being reported are transient ischemic attacks.The average time to event was one hundred and six days f ollowing the implant procedure.The patient ages in this report range from 56 to 90 and over.There were 24 males and 20 females.The type of serious injury information provided is limited in nature as it is provided via a third-party database.Medtronic received information regarding patient/device events via a third-party post-implant device registry (the society of thoracic surgeons/american college of cardiology transcatheter valve therapy registry).The information in this report was provided to medtronic in a de-identified format and has been organized into summaries of observations related to patient serious injuries.

• Brand Name: EVOLUT PRO PLUS VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16238162
• MDR Text Key: 308065727
• Report Number: 2025587-2023-00283
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Exemption Number: E2014038
• Number of Events Reported: 44
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: COREVALVE EVOLUTPRO+ & ENVEO SYSTEM (23MM, 26MM, 29MM, & 34MM)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Life Threatening
• Patient Age: 82 YR
• Patient Weight: 79 KG