BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENDRA DELIVERY SYSTEM

    MDR report key: 2981497 · Received February 27, 2013

    Report

    Report Number
    2015691-2013-19406
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE ASCENDRA BALLOON CATHETER WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. THE COMPLAINT WAS NOT CONFIRMED. PRELIMINARY INVESTIGATION DID NOT REVEAL A LEAK WHEN THE FLUSHED LOADER WITH THE DELIVERY SYSTEM WAS INSERTED. FOLLOW UP EXAMINATION PENDING.

    Additional Manufacturer Narrative · 1

    THE ASCENDRA BALLOON CATHETER WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. VISUAL INSPECTION AND A HEMOSTASIS LEAK TEST WERE PERFORMED. VISUAL INSPECTION REVEALED NO ABNORMALITIES WITH THE HOUSING OR SEALS OF THE LOADER. THE VALVE WAS STILL CRIMPED ONTO THE DELIVERY SYSTEM AS RECEIVED. THE LOADER CAP WAS THEN FULLY TIGHTENED ONTO THE DELIVERY SYSTEM AND FLUSHED AND NO LEAK WAS OBSERVED. THE LOADER CAP WAS THEN LOOSENED UNTIL THE DELIVERY SYSTEM COULD MOVE AND WAS FLUSHED. NO LEAK WAS OBSERVED. A HEMOSTASIS LEAK TEST WAS PERFORMED AND WAS FOUND TO MEET SPECIFICATIONS REVIEW OF COMPLAINT DATABASE REVEALED NO SIMILAR PRODUCT RETURNED COMPLAINTS OF LOADER LEAKAGE. THE COMPLAINT COULD NOT BE CONFIRMED AND NO MANUFACTURING NON-CONFORMITIES WERE IDENTIFIED IN THE RETURNED PRODUCT. THE LOADER IS DESIGNED TO PROVIDE A HEMOSTASIS SEAL WHEN THE CAP IS TIGHTENED, WHILE STILL ALLOWING THE CATHETER TO MOVE WITH MINIMAL RESISTANCE. IN THIS CASE, THE LOADER CAP WAS ABLE TO BE FULLY TIGHTENED TO PREVENT MOVEMENT OF THE DELIVERY SYSTEM AS WELL AS SLIGHTLY LOOSENED TO ALLOW THE DELIVERY SYSTEM TO MOVE. HEMOSTASIS TESTING IN THE LATTER CONDITION SHOWED THAT THE DEVICE CAN ACHIEVE A HEMOSTASIS SEAL WITHOUT ANY LEAKAGE. THUS, THE DEVICE WAS ABLE TO FUNCTION AS INTENDED. IT IS POSSIBLE THAT THE CAP WAS OVERLY LOOSENED DURING THE CASE WHICH WOULD CAUSE A LEAK. IT SHOULD BE NOTED THAT THE AMOUNT OF LEAKAGE OCCURRING AT THE CASE WAS MINOR AS IT DID NOT RESULT IN ANY ADDITIONAL INTERVENTION (TRANSFUSION). THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST (CS), DURING THE TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, UPON INSERTION OF THE ASCENDRA BALLOON CATHETHER INTO THE SHEATH AND AFTER CLOSING THE BLEEDBACK VALVE, THE PHYSICIAN AND PROCTOR NOTICED BLOOD CONTINUING TO EMERGE RAPIDLY FROM THE CENTER OF THE BLEEDBACK VALVE ON THE LOADER CAP. THE PHYSICIAN REMOVED THE VALVE FROM THE SHEATH AND A NEW VALVE WAS PREPPED AND CRIMPED ON A NEW DELIVERY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85497 ASCENDRA DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100BCL23

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR