BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS NOVAFLEX+ DELIVERY SYSTEM

    MDR report key: 4223269 · Received November 4, 2014

    Report

    Report Number
    2015691-2014-02604
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DEVICE WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. DUE TO NO PRODUCT (OR PHOTO) BEING RETURNED, VISUAL, FUNCTIONAL AND DIMENSIONAL TESTING COULD NOT BE PERFORMED. DHR, COMPLAINT HISTORY REVIEW, AND MANUFACTURING MITIGATIONS DID NOT REVEAL ANY COMPONENT ISSUES THAT COULD HAVE CONTRIBUTED TO THIS EVENT. WITHOUT THE DEVICE BEING RETURNED, THE CAUSE OF THE BALLOON LEAKAGE COULD NOT BE DETERMINED. REVIEW OF COMPLAINT HISTORY DID NOT REVEAL THAT THE OCCURRENCE RATE EXCEEDED THE CONTROL LIMITS FOR THIS TREND CATEGORY. DURING MANUFACTURING, ALL BALLOON CATHETERS UNDERGO MULTIPLE 100% INSPECTIONS. THESE INSPECTIONS MAKE IT UNLIKELY THAT A MANUFACTURING NON-CONFORMANCE WAS THE SOURCE OF THE COMPLAINT. DUE TO NO PRODUCT BEING RETURNED FOR EVALUATION, THE COMPLAINT OF THE BALLOON LEAK COULD NOT BE CONFIRMED, HOWEVER, SINCE NO LABELING, IFU/TRAINING INADEQUACIES HAVE BEEN IDENTIFIED AND COMPLAINT HISTORY FOR THIS TREND CATEGORY DID NOT REVEAL THAT THE OCCURRENCE RATES WERE OVER CONTROL LIMITS, NO CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    EDWARDS LIFESCIENCES CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DURING THE TRANSFEMORAL TAVR PROCEDURE, THE NOVAFLEX+ (NF+) DELIVERY SYSTEM (DS) BALLOON COULD NOT BE DE-AIRED DURING PREP. A HOLE WAS OBSERVED IN THE BALLOON. FLUID WAS OBSERVED COMING OUT OF THE BALLOON MATERIAL. THE DS BALLOON WAS PREPARED USING STANDARD PREP PROCEDURE. NO TOOLS WERE USED TO REMOVE THE BALLOON COVER. THE DEVICE WAS DISCARDED. A SECOND DS WAS SUCCESSFULLY PREPPED AND USED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705431 EDWARDS NOVAFLEX+ DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9355FS23 59738042

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention