BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS RETROFLEX 3/SAPIEN DELIVERY SYSTEM

    MDR report key: 2863580 · Received December 10, 2012

    Report

    Report Number
    2015691-2012-18796
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P100041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO EDWARDS IN USED CONDITION. PRIOR TO FUNCTIONAL TESTING, MULTIPLE CREASES WERE SEEN ON THE BALLOON AREA. THE RETURNED DELIVERY SYSTEM WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) IN ORDER TO SIZE THE BALLOON TO MEASURE THE BALLOON'S OUTER DIAMETER WHEN FULLY INFLATED. WHILE PREPARING THE DEVICE, IT WAS NOTED THAT THE BALLOON WAS NOT ABLE TO BE DE-AIRED. HOWEVER, THE BALLOON WAS STILL SIZED TO TAKE THE BALLOON DIAMETER. DURING THE DIAMETER MEASUREMENTS A LEAK PATH WAS NOTICED AT THE GUIDEWIRE LUER AREA, BUT THE BALLOON MAINTAINED ITS SIZE AND WAS FOUND TO MEET MANUFACTURING SPECIFICATION. THE DELIVERY SYSTEM FAILED THE PRESSURE DECAY LEAK TEST. POST TESTING, A VISUAL INSPECTION OF THE Y-CONNECTOR REVEALED A VISUAL INDICATION OF A LEAK PATH AT THE Y-CONNECTOR BETWEEN THE BALLOON PORT AND GUIDEWIRE PORT THROUGH THE ADHESIVE AROUND THE GUIDEWIRE LUMEN. A DHR REVIEW DID NOT REVEAL ANY ISSUES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. A LOT HISTORY REVIEW DID NOT REVEAL ANY SIMILAR COMPLAINTS UNDER THE SAME LOT. PER MANUFACTURING GUIDELINES, THERE IS A 100% LEAK TEST PERFORMED ON ALL DELIVERY SYSTEMS AND THE Y-CONNECTOR BONDS ARE 100% INSPECTED FOR VOIDS, BUBBLES, AND VISUAL DEFECTS. THESE INSPECTIONS MAKE IT UNLIKELY THAT A PRE-EXISTING LEAK PATH WAS PRESENT DURING THE MANUFACTURING PROCESS. IT IS DIFFICULT TO DETERMINE IF THE LEAK PATH CONDITION OF THIS SPECIFIC UNIT WAS MISSED IN MANUFACTURING OR IF IT DEVELOPED AT SOME POINT AFTER COMPLETION OF THE MANUFACTURING PROCESS. THE IFU STEPS FOR PREPPING THE RETROFLEX3 DELIVERY SYSTEM IS TO FIRST DE-AIR THE SYSTEM AND THEN TO INFLATE THE BALLOON INSIDE THE BALLOON GAUGE UNTIL THE BALLOON REACHES THE CORRECT DIAMETER WHEN FULLY INFLATED. AFTER THE BALLOON IS PROPERLY SIZED THE BALLOON IS DEFLATED. THE PREPPING AND BALLOON SIZING MAKE IT HIGHLY LIKELY THAT A Y-CONNECTOR LEAK PATH WOULD BE DETECTED BEFORE EVER REACHING A PATIENT. THE COMPLAINT WAS CONFIRMED AS THE DELIVERY SYSTEM WAS UNABLE TO BE DE-AIRED AND A LEAK PATH WAS OBSERVED AT THE Y-CONNECTOR. THE ROOT CAUSE OF THE LEAK IN THE DELIVERY SYSTEM WAS DETERMINED TO BE A LEAK PATH IN THE Y-CONNECTOR TO THE GUIDEWIRE SHAFT BOND. IN RESPONSE, A RETRAINING WAS PERFORMED AS MITIGATION. TRENDING FOR THIS ISSUE WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING PREPARATION OF THE RETROFLEX3 DELIVERY SYSTEM THE BALLOON GRADUALLY LOST PRESSURE DESPITE ADDITIONAL VOLUME BEING PUSHED IN WITH THE SYRINGE. ALL OF THE CONNECTIONS WERE CHECKED AND THERE WERE NO VISIBLE LEAKS. THE SAME SYRINGE WAS USED SUCCESSFULLY WITH THE SECOND DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS RETROFLEX 3/SAPIEN DELIVERY SYSTEM TRANSCATHETER HEART VALVE DELIVERY SYSTEM LWR EDWARDS LIFESCIENCES 9120FS26 59283611

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR