BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 7581882 · Received June 8, 2018

    Report

    Report Number
    2015691-2018-02198
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Date of Event
    April 30, 2018
    Report Date
    May 15, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #2800; BRAND NAME: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS; PMA #P860057/S001. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT. THE CLINICAL OBSERVATION WAS UNABLE TO BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWS THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. A MANUFACTURING NON-CONFORMANCE WAS NOT IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. THE INSTRUCTIONS FOR USE (IFU) HAS BEEN REVIEWED AND NO INADEQUACIES WERE IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. 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 · 1

    EDWARDS LEARNED THAT A 27MM VALVE WITH SERIAL NUMBER (B)(4) HAD A MISMATCH WITH THE LABELING AFFECTING THE SIZE AND SERIAL NUMBER OF THE VALVE. IT WAS DETERMINED THAT THE EXTERNAL LABELING (WHITE BOX AND JAR) INDICATED THAT THE VALVE WAS SIZE 25MM AND SERIAL NUMBER (B)(4), BUT IT WAS ACTUALLY A 27MM VALVE WITH SERIAL NUMBER (B)(4). THE CORRECT SIZE AND SERIAL NUMBER WOULD HAVE APPEARED ON THE BLUE IDENTIFICATION TAG ATTACHED TO THE VALVE. THROUGH FOLLOW UP WITH THE CUSTOMER IT WAS CONFIRMED THAT THE VALVE WAS IMPLANTED SUCCESSFULLY IN (B)(6) OF THIS YEAR WITH NO ISSUES AND THAT THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425526 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 290025MM

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR