BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROFLEX 3 DELIVERY SYSTEM

    MDR report key: 2981733 · Received February 27, 2013

    Report

    Report Number
    2015691-2013-19409
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED TO EDWARDS FOR EVALUATION. VISUAL INSPECTION AND DIMENSIONAL/FUNCTIONAL EVALUATIONS WERE PERFORMED. THE REPORTED LEAK AT THE Y-CONNECTOR WAS CONFIRMED; HOWEVER, DURING FUNCTIONAL TESTING, THE BALLOON WAS ABLE TO MAINTAIN INFLATION AT ITS FULL DIAMETER. 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. A PARTIAL LEAK PATH WAS OBSERVED DUE TO THE ABSENCE OF ADHESIVE IN THAT AREA. DURING MANUFACTURING THERE IS A 100% LEAK TEST PERFORMED ON EVERY RF3 DELIVERY SYSTEM. ADDITIONALLY, THE Y-CONNECTOR BONDS ARE 100% INSPECTED FOR VOIDS, BUBBLES, OR VISUAL DEFECTS. PER THE MANUFACTURING PROCEDURES, COMPONENTS WHERE THE ADHESIVE IS COVERING LESS THAN 90% OF THE BONDS SURFACE SHOULD BE REJECTED, OR IF THERE IS ANY VISUAL INDICATION OF LEAK PATH, EXCESSIVE ADHESIVE ON THE OUTSIDE OF THE Y-CONNECTOR, EVIDENCE OF ADHESIVE WITHIN THE OUTER SHAFT OR GW LUMENS, PARTICULATE CAPTURE, BURNS, OR OTHER VISUAL DEFECTS. THESE INSPECTIONS MAKE IT UNLIKELY THAT A PRE-EXISTING LEAK PATH WAS PRESENT DURING THE MANUFACTURING PROCESS. HOWEVER, IT IS DIFFICULT TO DEFINITIVELY 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. A RE-TRAINING OF THE MANUFACTURING OPERATORS WAS PERFORMED TO REJECT FOR LEAK PATHS IN THE Y-CONNECTOR TO GUIDEWIRE LUMEN BOND AND TO HAVE A MINIMUM OF 90% ADHESIVE COVERAGE IN THE BOND AREA. IN ADDITION, A CAPA WAS INITIATED FOR FURTHER INVESTIGATION. OF NOTE, ACCORDING TO THE IFU AND RF3 TRAINING MANUALS, THE STEPS FOR PREPPING THE RF3 DELIVERY SYSTEM PRIOR TO USE INCLUDE DE-AIRING THE SYSTEM AND THEN INFLATING 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 PRIOR TO USE MAKE IT HIGHLY UNLIKELY THAT A Y-CONNECTOR LEAK PATH WOULD NOT BE DETECTED BEFORE BEING INTRODUCING THE DEVICE INTO THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED AT EDWARDS FOR EVALUATION. THE EVALUATION IS PENDING.

    Description of Event or Problem · 1

    AS REPORTED PER THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), WHILE PREPPING THE DELIVERY SYSTEM FOR A TRANSFEMORAL TAVR PROCEDURE, THE BALLOON PORT WAS LEAKING INTO THE WIRE LUMEN. DURING PREP, THE CATHETER WAS LOSING PRESSURE WHILE IN THE BALLOON GAGE. INITIALLY THERE WAS DIFFICULTY DE-AIRING (CONTINOUS BUBBLES), BUT ALL CONNECTIONS WERE CHECKED AND IT WAS CONFIRMED THAT ALL CONNECTIONS WERE TIGHT. INITIALLY THE BALLOON SEEMED TO BE HOLDING PRESSURE BUT DURING SIZING, IT FELT LIKE THE BALLOON WAS GETTING SOFTER OVER TIME. THERE WAS LESS RESISTANCE WHEN SIZING THE BALLOON INTO THE GAUGE. ADDITIONALLY, CONTRAST FLUID WAS SEEN LEAKING OUT OF THE WIREPORT. A TOWEL WAS PUT DOWN TO VERIFY THE FLUID LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83648 RETROFLEX 3 DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS23US 59334671

    Patients

    Seq Age Sex Outcome Treatment
    1