BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESES

    MDR report key: 16364536 · Received February 13, 2023

    Report

    Report Number
    2015691-2023-10769
    Event Type
    Injury
    Date Received
    February 13, 2023
    Date of Event
    December 20, 2022
    Report Date
    April 11, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    UDI-DI
    00690103186260
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION IS IN PROCESS. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION RECEIVED THIS CORRECTION IS BEING SUBMITTED. THIS REPORT IS A DUPLICATE OF MFR 2015691-2023-10775. PLEASE REFER TO MFR 201569-2023-10775 FOR ALL INFORMATION RELATED TO THIS EVENT.

    Description of Event or Problem · 0

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL CUSTOMER COMPLAINT. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 11 DAYS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 26MM 9600TFX TRANSCATHETER VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682273 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESES REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES 7300TFX NA 00690103186260

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male Required Intervention| H| L