BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS NOVAFLEX+ DELIVERY SYSTEM

    MDR report key: 4061602 · Received September 4, 2014

    Report

    Report Number
    2015691-2014-02060
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 11, 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

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DESCRIPTION OF EVENT OR PROBLEM, THE DEVICE WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. VISUAL INSPECTION REVEALED A TEAR ON THE CRIMP BALLOON. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE TEAR. DHR REVIEW DID NOT REVEAL ANY COMPONENT ISSUES THAT COULD HAVE CONTRIBUTED TO THIS EVENT. DIMENSIONAL TESTING WAS PERFORMED ON THE RETURNED DEVICE. THE DOUBLE WALL THICKNESS OF THE CRIMP BALLOON WAS MEASURED. ALL MEASUREMENTS MEET THE DOUBLE WALL THICKNESS SPECIFICATIONS. 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. THE COMPLAINT OF THE BALLOON LEAK WAS CONFIRMED, HOWEVER NO MANUFACTURING NON-CONFORMANCES WERE FOUND IN THE RETURNED SAMPLE. AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (DAMAGE TO THE DEVICE WITH BLUNT END SCISSORS DURING REMOVAL OF THE BALLOON COVER) LIKELY CONTRIBUTED T THE EVENT. SINCE NO LABELING, IFU/TRAINING INADEQUACIES HAVE BEEN IDENTIFIED, NO CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    DURING DEVICE PREP FOR A TRANSFEMORAL TAVR PROCEDURE, THE NOVAFLEX+ (NF+) DELIVERY SYSTEM (DS) COULD NOT BE DE-AIRED. WHILE PULLING NEGATIVE, THE SYSTEM JUST PULLED AIR. A SMALL LEAK WAS OBSERVED IN THE DS BALLOON. A SECOND DS WAS PREPARED AND USED FOR THE PROCEDURE.

    Description of Event or Problem · 1

    DURING DEVICE PREP FOR A TRANSFEMORAL TAVR PROCEDURE, THE NOVAFLEX+ (NF+) DELIVERY SYSTEM (DS) COULD NOT BE DE-AIRED. WHILE PULLING NEGATIVE, THE SYSTEM JUST PULLED AIR. A SMALL LEAK WAS OBSERVED IN THE DS BALLOON. A SECOND DS WAS PREPARED AND USED FOR THE PROCEDURE. IT WAS CONFIRMED THAT DUE TO DIFFICULTY REMOVING THE BALLOON COVER, BLUNT END SCISSORS WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541862 EDWARDS NOVAFLEX+ DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9355FS26 59729876

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR