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

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

Device Problem Insufficient Information (3190)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 02/06/2024

Event Type  Injury  

Manufacturer Narrative

Tvt registry exemption number: (b)(4) quarterly reporting period: q1 2024 total number of events being summarized: 5 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 in section a.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.The views or opinions presented here do not represent those of the american college of cardiology foundation, the society of thoracic surgeons, or the sts/acc tvt registry.The industry data file upon which the analysis was performed is a subset of the full sts/acc tvt registry data submissions.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

The types of serious injuries being reported are conduction disturbances requiring pacing support or an implantable cardioverter defibrillator.The average time to event was forty-five days following the implant procedure.The patient ages in this report range from 77 to 84.There were 3 males and 2 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 R TRANSCATHETER AORTIC 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: 19160348
• MDR Text Key: 340796050
• Report Number: 2025587-2024-02456
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Exemption Number: E2014038
• Number of Events Reported: 5
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: COREVALVE EVOLUT R & ENVEO SYSTEM (23MM, 26MM, 29MM, & 34MM)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• 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): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 85 KG