BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 18383924 · Received December 22, 2023

    Report

    Report Number
    2015691-2023-18731
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    July 29, 2015
    Report Date
    February 23, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE ADDITIONAL INFORMATION OBTAINED, THIS EVENT IS NO LONGER CONSIDERED REPORTABLE AND THIS CORRECTION IS BEING SUBMITTED.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION AVAILABLE, THE DEVICE WAS INTENTIONALLY USED OUTSIDE THE WAY IT WAS DESIGNED AND INTENDED. THE PERFORMANCE, SAFETY, EFFICACY, LONGEVITY, AND DURABILITY OF RINGS AND BIOPROSTHETIC VALVES HAVE NOT BEEN DETERMINED WHEN THE PRODUCT IS USED OUTSIDE THE SCOPE OF ITS INTENDED USE AND/OR ITS STUDIED POPULATION. AN ENGINEERING EVALUATION IS NOT REQUIRED BECAUSE THERE IS NO ALLEGATION 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. AN IFU REVIEW IS 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 NON-CONFORMANCES AND NO OTHER TRIGGERS ARE MET. BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED.

    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.

    Description of Event or Problem · 0

    2023-27703-01 WILL BE VOIDED AS NON-COMPLAINT BECAUSE THE EDWARDS VALVE THAT WAS EXPLANTED DURING THE PVR CAPTURED IN THIS FILE WAS CONFIRMED TO NOT ACTUALLY BE PRESENT DUE TO AN INCORRECT MEDICAL HISTORY CAUSED BY THE DOCTOR'S WRITING ERROR. IT WAS LEARNED THROUGH 2023-27627-01 AND INVESTIGATION THAT AN EDWARDS VALVE IMPLANTED IN THE PULMONARY POSITION WITH AN IMPLANT DURATION OF ONE (1) YEAR, SEVEN (7) MONTHS WAS EXPLANTED (B)(6)2015 DUE TO UNKNOWN REASONS.

    Description of Event or Problem · 0

    IT WAS LEARNED THAT AN EDWARDS VALVE IMPLANTED IN THE PULMONARY POSITION WITH AN IMPLANT DURATION OF ONE (1) YEAR, SEVEN (7) MONTHS WAS EXPLANTED DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308073 NI REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES NI

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Life Threatening| R| H