BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENDRA DELIVERY SYSTEM

    MDR report key: 3181697 · Received June 21, 2013

    Report

    Report Number
    2015691-2013-20396
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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

    THE DELIVERY SYSTEM WAS RETURNED IN A USED CONDITION. NO ABNORMALITIES WERE OBSERVED IN THE RETURNED DEVICE. THE DEVICE WAS ABLE TO BE SUCCESSFULLY DE-AIRED WITHOUT ISSUE. THE DEVICE WAS THEN INFLATED TO VOLUME AND INFLATED/DEFLATED WITHOUT ISSUE. INFLATION/DEFLATION TESTING WAS PERFORMED, THE BALLOON WAS INFLATED TO NOMINAL VOLUME, HELD FOR 10 SECONDS (NOT INCLUDED IN INFLATION/DEFLATION TIME), AND WAS THEN DEFLATED. THIS TIME WAS MEASURED TO BE 8.96 SECONDS WHICH MEETS THE SPECIFICATION OF TOTAL TIME TO INFLATE AND DEFLATE BALLOON. TO DETERMINE IF THE REPORTED COMPLAINT OF DEFLATION DIFFICULTY WAS DUE TO AIR ENTERING THE SYSTEM, AIR LEAK TESTING WAS COMPLETED. THE DELIVERY SYSTEM MET THE AIR LEAK DECAY SPECIFICATION. RED DYE TESTING WAS DONE TO FURTHER INVESTIGATE THE PRESENCE OF A POSSIBLE LEAK IN THE SYSTEM. NO LEAK PATHS WERE OBSERVED WHILE PERFORMING RED DYE TESTING. THE BALLOON OD TESTING WAS PERFORMED IN WHICH THE BALLOON OD WAS MAINTAINED FOR 20 SECONDS WITH NO SIGNIFICANT DROP IN OD SIZE. IT SHOULD BE NOTED THE BALLOON DID NOT MEET THE OD SPECIFICATION OF 25.5±0.5MM; HOWEVER, SIZING OF THE BALLOON IS A MANUAL PROCESS AND PREPPING OF THE BALLOON CAN RESULT IN VARIATION OF BALLOON OD. THE RF3 DELIVERY SYSTEM, WHICH IS ALSO USED TO DEPLOY THE SAPIEN VALVE, HAS A BALLOON OD SPECIFICATION OF 25.5±1MM THEREFORE IF THE BALLOON WERE TO BE INFLATED TO THE SIZE SEEN DURING INFLATION OD TESTING THE VALVE WOULD STILL HAVE FULLY DEPLOYED. ENGINEERING EVALUATION REVEALED NO MANUFACTURING NON-CONFORMANCES AND COULD NOT CONFIRM THE DEFLATION DIFFICULTY. NO ABNORMALITIES WERE OBSERVED IN THE RETURNED DELIVERY SYSTEM AND INFLATION/DEFLATION TIME MET SPECIFICATION. . ACCESSORIES USED DURING THE CASE SUCH AS STOPCOCKS, EXTENSION TUBES AND SYRINGES WERE NOT RETURNED FOR EVALUATION. THESE DEVICES MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. MALFUNCTION/DAMAGE OF ACCESSORIES COULD CAUSE OCCLUSION OF THE LUMEN OR ALLOW AIR INTO THE SYSTEM WHICH BOTH CAN RESULT IN INABILITY TO DEFLATE THE BALLOON. OTHER PROCEDURAL FACTORS CAN ALSO CONTRIBUTE TO INCREASED INFLATION/DEFLATION TIME. IF AN INCORRECT CONTRAST/SALINE RATIO IS USED DURING PREPPING OF THE DEVICE IT CAN LEAD TO AN INCREASED VISCOSITY OF THE CONTRAST SOLUTION. THIS INCREASED VISCOSITY CAN LEAD TO DIFFICULTY INFLATING/DEFLATING AND LONGER INFLATION/DEFLATION TIME. TO PREVENT THIS FROM OCCURRING THE IFU STATES THAT A 15:85 CONTRAST TO HEPARINIZED SALINE SOLUTION SHOULD BE USED FOR PREPPING THE DELIVERY SYSTEM. THE COMPLAINT OF DEFLATION DIFFICULTY COULD NOT BE CONFIRMED, AND NO LABELING INADEQUACIES WERE IDENTIFIED. REVIEW OF COMPLAINT HISTORY DID NOT REVEAL THAT OCCURRENCE RATE EXCEEDS THE (B)(6) 2013 CONTROL LIMITS FOR THIS FAILURE MODE. THEREFORE, NO FURTHER PREVENTATIVE OR CORRECTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST THAT, DURING DEVICE PREPARATION THEY WERE UNABLE TO DEFLATE THE BALLOON OF THE ASCENDRA DELIVERY CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283204 ASCENDRA DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100BCL26W 59348851

    Patients

    Seq Age Sex Outcome Treatment
    1