BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 11986935 · Received June 11, 2021

    Report

    Report Number
    2015691-2021-03550
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    May 12, 2021
    Report Date
    August 24, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DTI
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: EVALUATION SUMMARY: CUSTOMER REPORT OF SIZING ISSUES WAS UNABLE TO BE CONFIRMED. MEASUREMENTS WERE TAKEN OF RETURNED 27MM SIZER PER DRAWING 110415 REV. AE. ALL MEASUREMENTS WERE WITHIN SPECIFICATION. SPECIFICATION A ON RETURNED SIZER MEASURED AT 1.246"; SPECIFICATION IS 1.25" +/- 0.01". SPECIFICATION B ON RETURNED SIZER MEASURED AT 0.4700"; SPECIFICATION IS 0.470" +/- 0.005". SPECIFICATION C ON RETURNED SIZER MEASURED AT 1.0600"; SPECIFICATION IS 1.063" +/- 0.005".

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: IN THIS CASE, IT WAS REPORTED THAT THE SIZER MIGHT BE AN INACCURATE REPRESENTATION FOR A 27MM 2800TFX VALVE. THE SIZER WENT THROUGH THE ANNULUS BUT THE RESPECTIVE VALVE WAS NOT IMPLANTED AS IT WAS TOO LARGE. THE PATIENT WAS NOTED TO BE DOING WELL POST PROCEDURE WITH NO ISSUES. HOWEVER, THE EVENT IS BEING REPORTED DUE TO THE POTENTIAL OF IMPLANTING A WRONG SIZE VALVE. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. IF RETURNED AND EVALUATED, A SUPPLEMENTARY REPORT WILL BE SUBMITTED WITH THE FINDINGS. THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED AS THE DEVICE SERIAL NUMBER WAS NOT PROVIDED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 27MM 2800TFX (2021-08859-01) PERICARDIAL AORTIC VALVE EXPLANTED AT IMPLANT DUE TO SIZING ISSUES. THE VALVE WAS EXPLANTED AND THE AVR WAS ATTEMPTED WITH A 25MM 2800TFX (2021-08859-02) PERICARDIAL AORTIC VALVE WHICH WAS ALSO EXPLANTED AT IMPLANT DUE TO SIZING ISSUES. THE VALVE WAS EXPLANTED AND REPLACED WITH A 23MM 2800TFX PERICARDIAL VALVE WHICH SEATED WELL WITH NO ISSUES. THE PATIENT WAS NOTED TO BE DOING WELL POST PROCEDURE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION OR PRODUCT DEFICIENCY AGAINST EITHER THE EXPLANTED 27MM 2800TFX VALVE OR THE 25MM 2800TFX VALVE. PER THE SURGEON, THE 27 (2021-08859-03) AND 25 (2021-08859-04) SIZERS PASSED THROUGH THE ANNULUS BUT THE RESPECTIVE VALVES WERE TOO LARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885002 NI SIZER, HEART-VALVE, PROSTHESIS DTI EDWARDS LIFESCIENCES NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other