BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10.

    MDR report key: 7537874 · Received May 23, 2018

    Report

    Report Number
    2015691-2018-01954
    Event Type
    Malfunction
    Date Received
    May 23, 2018
    Date of Event
    April 30, 2018
    Report Date
    April 30, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 NUMBER 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 EVENTS THROUGH THE USE OF EDWARDS QUALITY SYSTEMS. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PACKAGED 27MM VALVE WITH SERIAL NUMBER (B)(4) WAS OPENED AND THE ID TAG ATTACHED TO THE 27MM VALVE SHOWED 25MM SERIAL NUMBER (B)(4). BEFORE OPENING THE 27MM VALVE, THE SURGEON SELECTED THE 27MM VALVE BECAUSE THE PATIENT'S ANNULUS WAS IN BETWEEN SIZE 25 AND 27. THE SURGEON SIZED THE ANNULUS WITH BOTH 25 AND 27 SIZERS. THE SURGEON PREFERS TO IMPLANT A BIGGER SIZE. HE THEN COMPARED THE SUBJECT DEVICE WITH BOTH SIZERS AND THE VALVE WAS INDEED 25MM. HE IMPLANTED THE SUBJECT DEVICE IN THE PATIENT. THE IMPLANTATION WAS SUCCESSFUL AND THE PATIENT WAS REPORTED TO BE DOING WELL WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378411 SEE H10. HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 2900MU27MM 5755727

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR