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

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

Device Problem Mechanical Problem (1384)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/10/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6) registry exemption number: e2014038.Quarterly reporting period: q4 2021.Total number of events being summarized: 4.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 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

The type of serious injuries being reported are aortic valve reinterventions due to regurgitation.The average time to event was ninety seven days following the implant procedure.The patient¿s ages in this report range from 66 to 90 and over.There were 4 males and 0 female.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 (b)(6) 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13357636
• MDR Text Key: 284448711
• Report Number: 2025587-2022-00264
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Exemption Number: E2014038
• Number of Events Reported: 4
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• 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: 76 YR
• Patient Weight: 93 KG