BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 18040599 · Received October 31, 2023

    Report

    Report Number
    2015691-2023-17166
    Event Type
    Injury
    Date Received
    October 31, 2023
    Date of Event
    August 29, 2023
    Report Date
    December 11, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: 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

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. AN ENGINEERING EVALUATION IS NOT REQUIRED BECAUSE THERE IS NO ALLEGATION OF A MALFUNCTION WHICH COULD BE RELATED TO A MANUFACTURING NON-CONFORMANCE; NO LABELING NON-CONFORMANCE/DEFICIENCY; NO USE-RELATED ISSUE WITH A HAZARDOUS SITUATION; NO DEVICE-RELATED INFECTION; AND THERE IS NO EVIDENCE OF A PRODUCT FAILURE WITH REGARD TO DESIGN, RELIABILITY, OR USE ERROR. IFU REVIEW UNABLE TO BE PERFORMED, AS NO DETAILS REGARDING A FAILURE MODE OF THE DEVICE WERE PROVIDED. A CAPA/SCAR/PRA IS NOT REQUIRED AS THERE ARE NO CONFIRMED PRODUCT OR LABELING NONCONFORMANCES AND NO OTHER TRIGGERS ARE MET. BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 27MM 7300TFX PERICARDIAL MITRAL VALVE UNDERWENT A REDO MITRAL VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF THREE (3) YEARS, THREE (3) MONTHS DUE TO UNKNOWN REASONS [2023-20419-01]. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M MITRIS VALVE. CONCOMITANTLY, THE PATIENT ALSO HAD A 27MM 3300TFX PERICARDIAL AORTIC VALVE IMPLANTED FOR THREE (3) YEARS, THREE (3) MONTHS THAT WAS EXPLANTED DUE TO UNKNOWN REASONS [2023-20419-02]. THIS EXPLANTED VALVE WAS REPLACED WITH A 25MM 11060A AORTIC VALVED CONDUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227361 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES 3300TFX27MM

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Life Threatening| R| H