BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 20875573 · Received December 8, 2024

    Report

    Report Number
    2015691-2024-09359
    Event Type
    Injury
    Date Received
    December 8, 2024
    Date of Event
    August 19, 2024
    Report Date
    January 11, 2025
    Manufacturer
    EDWARDS LIFESCIENCES, LLC
    Product Code
    DYE
    UDI-DI
    00690103186253
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: DUE DILIGENCE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION REGARDING A DEVICE FAILURE MODE, HOWEVER ADDITIONAL INFORMATION IS NOT AVAILABLE AT THIS TIME. PATIENT MEDICAL RECORDS WERE NOT PROVIDED BY THE HOSPITAL FOR REVIEW, OR THE MEDICAL RECORDS PROVIDED DO NOT CLARIFY THE DEVICE FAILURE MODE. IN THIS CASE, THERE IS NO EVIDENCE OF A MALFUNCTION WHICH COULD BE RELATED TO A MANUFACTURING NON CONFORMANCE AND OR ONE WAS NOT SUSPECTED OR CONFIRMED THROUGH INVESTIGATION NO LABELING NON CONFORMANCE DEFICIENCY NO USE RELATED ISSUE WITH A HAZARDOUS SITUATION NO DEVICE RELATED INFECTION AND NO EVIDENCE OF A PRODUCT FAILURE WITH REGARD TO DESIGN, RELIABILITY, OR USE ERROR BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED.THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION . DHR WAS NOT PERFORMED. A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED

    Description of Event or Problem · 0

    IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 9 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 7300TFX MITRAL VALVE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305283 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES, LLC 7300TFX 00690103186253

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Hospitalization| R| L