BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 22836667 · Received August 19, 2025

    Report

    Report Number
    2015691-2025-06796
    Event Type
    Injury
    Date Received
    August 19, 2025
    Date of Event
    May 27, 2025
    Report Date
    September 2, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    UDI-DI
    00690103186277
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: 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 REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTION B4 (DATE OF THIS REPORT). UPDATED SECTION B5 (DESCRIBE EVENT OR PROBLEM). UPDATED SECTION G3 (DATE RECEIVED BY MANUFACTURER). UPDATED SECTION G6 (TYPE OF REPORT). UPDATED SECTION H2 (IF FOLLOW-UP, WHAT TYPE). H11: CORRECTED DATA: PER ADDITIONAL INFORMATION RECEIVED, THE REINTERVENTION OF THE MITRAL VALVE WAS DUE TO INFECTION AND WAS NOT DUE TO A DEFICIENCY IN THE DEVICE. BASED ON THIS INFORMATION, THIS EVENT IS NO LONGER CONSIDERED REPORTABLE AND THIS CORRECTION IS BEING SUBMITTED.

    Description of Event or Problem · 0

    IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 29MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 2 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M 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.

    Description of Event or Problem · 0

    IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 29MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 2 MONTHS DUE TO INFECTION. THE PATIENT PRESENTED WITH RIGHT LOWER EXTREMITY NUMBNESS, PERSISTENT FATIGUE, NIGHT SWEATS AND WEIGHT LOSS. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M VALVE. PER MEDICAL RECORDS RECEIVED, THE PATIENT UNDERWENT REDO-MVR WITH 31MM 11400M VALVE, AND REDO- AVR WITH 23MM INSPIRIS VALVE (2025-20604-02) WITH RECONSTRUCTION OF THE INTERVALVULAR FIBROSA WITH PERICARDIUM PATCH AND ROOT ENLARGEMENT. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO IMMEDIATE COMPLICATIONS. PATHOLOGY REPORT, SHOWED MILD PANNUS WITHOUT ACUTE INFLAMMATION AND NO VEGETATION. 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
    1628230 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX NA 00690103186277

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Hospitalization| R| L