BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT PRO PLUS DCS

    MDR report key: 21933311 · Received April 30, 2025

    Report

    Report Number
    2025587-2025-03225
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    January 5, 2022
    Report Date
    April 30, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000207861
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: PRODUCT ID: EVPROPLUS-34US (SERIAL: (B)(6)); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE N/A; EXPLANT DATE N/A; 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS ATTEMPTED TO BE DEPL OYED THREE TIMES, HOWEVER IT WAS REPORTED THAT THE VALVE WOULD NOT REMAIN IN PLACE WHILE 80% DEPLOYED. THE PATIENT PRESENTED WITH PRE-EXISTING SEVERE AORTIC INSUFFICIENCY, WHICH MADE THE DEPLOYMENT ATTEMPTS CHALLENGING. THE VALVE WAS ULTIMATELY RECAPTURE AND RETRIEVED FROM THE PATIENT. THE IMPLANT PROCEDURE WAS ABORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237066 EVOLUT PRO PLUS DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVPROP34US 0010498417 00763000207861

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male