BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT PRO PLUS DCS

    MDR report key: 21960311 · Received May 5, 2025

    Report

    Report Number
    2025587-2025-03378
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    October 27, 2022
    Report Date
    May 5, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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-34 (SERIAL: F120399); 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. 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 DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE INTO A PATIENT WITH A MULTIVALVULAR VITIUM CORDIS WITH AN PRE-EXISITING AORTIC REGURGITATION AND A MODERATE AORTIC STENOSIS, THE VALVE WAS NOT ABLE TO BE IMPLANTED DUE TO THE SEVERE AORTIC REGURGITATION PREVIOUSLY PRESENT. IT WAS REPORTED THERE WAS DIFFICULTY POSITIONING THE VALVE DUE TO THE AORTIC REGURGITATION AND THE VALVE DISLODGED BECAUSE OF THE AORTIC REGURGITATION. THE VALVE WAS RECAPTURED AND WITHDRAWN DUE TO THE HIGH RISK. THE PROCEDURE WAS ABORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820960 EVOLUT PRO PLUS DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVPROP34US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male SEE H11