BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS SAPIEN RETROFLEX 3 TRANSCATHETER HEART VALVE DELIVERY SYSTEM

    MDR report key: 3052970 · Received April 11, 2013

    Report

    Report Number
    2015691-2013-19791
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO EDWARDS IN USED CONDITION. THE DELIVERY SYSTEM WAS ATTEMPTED TO BE INFLATED TO DE-AIR THE SYSTEM. A LEAK WAS OBSERVED COMING FROM THE DISTAL END OF THE BALLOON. THE DEVICE COULD NOT HOLD VACUUM, AND THEREFORE COULD NOT BE DE-AIRED. UPON CLOSER INVESTIGATION IT WAS NOTED THE BALLOON MATERIAL WAS RAISED OFF OF THE NOSE TIP. INSUFFICIENCIES IN DISTAL LASER BALLOON TO NOSE TIP BOND CREATED A LEAK PATH ALLOWING FOR LIQUID TO ESCAPE FROM THE BALLOON. THE DELIVERY SYSTEM FAILED THE AIR LEAK TEST AS THE BALLOON COULD NOT HOLD PRESSURE. FURTHER TESTING WAS UNABLE TO BE PERFORMED DUE TO GROSS LEAK FROM THE BALLOON. A DEVICE HISTORY RECORD (DHR) DID NOT REVEAL ANY ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. ALL OF THE DELIVERY SYSTEMS IN THE AFFECTED WORK ORDER PASSED PRODUCT VERIFICATION TESTING. A LOT HISTORY REVIEW DID NOT REVEAL ANY SIMILAR COMPLAINTS. THE COMPLAINT WAS CONFIRMED FOR A LEAK AT THE BALLOON/NOSE TIP BOND. THE BALLOON MATERIAL WAS RAISED OFF OF THE NOSE TIP, CREATING A LEAK PATH. IN A PREVIOUS COMPLAINT, INSUFFICIENT LASER BONDING WAS ATTRIBUTED TO RESIDUAL MOLD RELEASE BEING PRESENT ON THE PLASTIC INJECTION MOLDED NOSE TIPS DURING THE LASER BONDING PROCESS. THIS DOES NOT ALLOW FOR OPTIMAL BONDING CONDITIONS, RESULTING IN POTENTIAL FORMATION OF LEAK PATHS. PER MANUFACTURING GUIDELINES, ALL BALLOONS UNDERGO A 100% LEAK TEST; HOWEVER, UPON RETURN, THE COMPLAINT UNIT FAILED THE AIR LEAK TEST. IT IS LIKELY THAT THE BOND, WHICH PASSED AIR LEAK TESTING DURING MANUFACTURING, WAS WEAKENED BY CONDITIONS EXPERIENCED DURING DE-AIRING BOTH AT THE CASE SITE AND DURING ENGINEERING EVALUATION. IT IS IMPORTANT TO NOTE THAT THE BALLOON FAILURE IS HIGHLY DETECTABLE PRIOR TO DEVICE INSERTION INTO THE PATIENT. PER PROCEDURE, THE USER MUST DE-AIR AND INFLATE THE DELIVERY SYSTEM'S BALLOON COMPLETELY DURING THE SIZING PORTION OF THE PROCEDURE, BEFORE INSERTION. ANY LEAKS, RUPTURES, OR DAMAGE TO THE BALLOON WOULD LIKELY BE DETECTED. A MANUFACTURING DEFECT WAS CONFIRMED ON THE RETURNED SAMPLE. DUE TO THE HIGH CRITICALITY LEVEL FOR THIS FAILURE MODE, CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED. HOWEVER, THE COMPLAINT DEVICE WAS MANUFACTURED BEFORE THESE CORRECTIVE ACTIONS WERE IMPLEMENTED. THERE HAVE BEEN NO DEVICES BUILT POST CORRECTIVE ACTIONS THAT HAVE RESULTED IN A LEAKAGE COMPLAINT AT THE DISTAL LASER BALLOON BOND. THEREFORE, NO FURTHER CORRECTIVE ACTION IS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, WHILE ATTEMPTING TO INFLATE THE BALLOON FOR DE-AIRING DURING DEVICE PREP, A FLUID LEAK AT THE POINT WHERE THE BALLOON IS ATTACHED TO THE NOSE CONE WAS NOTED. THE DELIVERY SYSTEM WAS DISCARDED AND NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154912 EDWARDS SAPIEN RETROFLEX 3 TRANSCATHETER HEART VALVE DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS23 59107616

    Patients

    Seq Age Sex Outcome Treatment
    1