BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 20698479 · Received November 15, 2024

    Report

    Report Number
    2025587-2024-06586
    Event Type
    Injury
    Date Received
    November 15, 2024
    Date of Event
    November 7, 2024
    Report Date
    November 15, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000211127
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 20 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AN ECHOCARDIOGRAM WAS PERFORMED THAT REVEALED MODERATE-SEVERE PARAVALVULAR LEAK (PVL), AND THE VALVE WAS 14 MILLIMETER'S (MM) DEEP IN THE VENTRICLE. SUBSEQUENTLY, A 10 MILLIMETER (MM) NON-MEDTRONIC VASCULAR PLUG WAS PERFORMED TO TREAT THE PVL. THE PVL IMPROVED TO MILD AND THE PATIENT LEFT THE OPERATING ROOM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144928 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVPROPLUS-29US 00763000211127

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Required Intervention| L| H