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

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

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

Patient Problem No Information (3190)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

Tvt registry exemption number: e2014038 quarterly reporting period: q3 2020 total number of events being summarized: 12 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.The patient information included.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.If information is provided in the future, a supplemental report will be issued.

Event Description

This report summarizes <(><<)>noe> 12 <(><<)>/noe> serious injury events.The type of serious injuries reported were events resulting in cardiopulmonary bypass.The average time to event was zero days following the implant procedure.The patient ages in this report range from 60 to 85 there were 3 males and 9 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.

Manufacturer Narrative

In accordance with modifications to summary reporting registry exemption e2014038 received on nov 9, 2020, the following information was received from the sts/acc tvt registry for the corevalve system.The tvt registry subsequently removed the following data: one cardiopulmonary bypass used.The total events are updated to 11.Updated data: h1 number of events (summary report).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.

• Brand Name: EVOLUT PRO PLUS VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10763133
• MDR Text Key: 213904190
• Report Number: 2025587-2020-03363
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Number of Events Reported: 11
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: COREVALVE EVOLUT PRO+ & ENVEO SYSTEM (23MM, 26MM, 29MM, & 34MM)
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR