BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVEO R DELIVERY SYSTEM

    MDR report key: 22385466 · Received July 2, 2025

    Report

    Report Number
    2025587-2025-04745
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    May 18, 2019
    Report Date
    July 2, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00643169800946
    PMA / PMN Number
    P130021
    Removal / Correction Number
    2025587-05-28-2021-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF REMEDIATION ACTIVITIES ASSOCIATED WITH CAPA 643143, ADDRESSING MDR REPORTING GUIDANCE FROM THE FDA¿S 1995 PREAMBLE, WHICH ENSURES COMPLAINTS RELATED TO CORRECTIONS AND RECALLS PREVIOUSLY REPORTED TO THE FDA UNDER 21 CFR 806 ARE NOW REPORTED AS MDRS; THIS IS NOT A NEW MALFUNCTION/EVENT. 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 THE DEPLOYMENT OF A TRANSCATHETER BIOPROSTHETIC VALVE (D143395), WITH THIS DELIVERY CATHETER SYSTEM (DCS), THE VALVE WAS DEPLOYED AND RECAPTURED DUE TO INADEQUATE POSITIONING. DURING THE RECAPTURING OF THE VALVE, THE ACTUATOR OF THE DCS SEPARATED. THE ACTUATOR WAS ABLE TO BE PUT BACK TOGETHER, HOWEVER THE CAPSULE WAS UNABLE TO BE RECAPTURED ANY FURTHER. THE DCS WAS PULLED THROUGH THE SHEATH WITHOUT ISSUE AND THE SYSTEM WAS REMOVED FROM THE PATIENT WITHOUT INJURY. ONCE REMOVED, THE VALVE WAS UNABLE TO BE TAKEN OUT OF THE DCS. THE VALVE AND THE DCS WERE REPLACED AND A NEW TRANSCATHETER BIOPROSTHETIC VALVE (D143752) WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8109 ENVEO R DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION ENVEOR-N 0009684328 00643169800946

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown