BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 9182802 · Received October 11, 2019

    Report

    Report Number
    2015691-2019-03767
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    September 26, 2019
    Report Date
    September 26, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    THE COMMANDER DELIVERY SYSTEM WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. IMAGERY WAS PROVIDED AND THE PATIENT¿S VASCULATURE WAS OBSERVED TO HAVE CALCIFICATION ALONG THE VESSEL WALLS. CALCIFICATION WAS ALSO VISIBLE NEAR THE SITE OF THE VALVE IMPLANT. DURING MANUFACTURING OF THE COMMANDER DELIVERY SYSTEM, THE DELIVERY SYSTEM AND COMPONENTS ARE INSPECTED SEVERAL TIMES THROUGHOUT THE MANUFACTURING PROCESS. IN ADDITION, PRODUCT VERIFICATION TESTING WAS PERFORMED ON A SAMPLING BASIS AND ALL TESTING MET SPECIFICATIONS. THESE INSPECTIONS PERFORMED DURING MANUFACTURING PROCESS AND TESTING PERFORMED DURING PRODUCT VERIFICATION SUPPORT THAT IT IS UNLIKELY THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE REPORTED EVENTS. A DHR REVIEW WAS PERFORMED AND DID NOT REVEAL ANY ISSUES THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT. A LOT HISTORY REVIEW WAS PERFORMED AND REVEALED NO OTHER COMPLAINTS RELATING TO THE EVENT. AS THE COMPLAINT WAS UNABLE TO BE CONFIRMED AND THE CONTROL LIMIT FOR THE ASSOCIATED TREND CATEGORY ¿LEAKAGE¿ WAS NOT EXCEEDED FOR SEPTEMBER 2019, A COMPLAINT HISTORY REVIEW IS NOT REQUIRED. THE IFU, DEVICE PREP MANUAL, AND PROCEDURAL TRAINING MANUAL WERE REVIEWED FOR INSTRUCTIONS AND/OR GUIDANCE FOR PROPER USE OF THE COMMANDER DELIVERY SYSTEM. THE IFU INSTRUCTS THE OPERATOR TO VISUALLY INSPECT ALL COMPONENTS FOR DAMAGE PRIOR TO USE. IF DELIVERY SYSTEM BALLOON RUPTURES OR LEAKS DURING DEPLOYMENT WITHOUT THV EMBOLIZATION: DO NOT USE EXCESSIVE FORCE. TAKE CARE WHEN CROSSING THE THV, TRACKING BACK OVER THE ARCH AND REMOVING THE DELIVERY SYSTEM (THROUGH THE TIP OF THE SHEATH). MAINTAIN GUIDEWIRE POSITION, CHECK FOR PV LEAKS UNDER ECHO, IF POST-DILATION NEEDED, USE A NEW DELIVERY SYSTEM. THE COMPLAINT WAS UNABLE TO BE CONFIRMED DUE TO THE UNAVAILABILITY OF THE DEVICE. NO MANUFACTURING NON-CONFORMANCE COULD BE DETERMINED WITHOUT DEVICE PHOTOS AND/OR DEVICE EVALUATION. A REVIEW OF THE DHR, LOT HISTORY, AND MANUFACTURING MITIGATIONS DID NOT PROVIDE ANY INDICATION THAT A MANUFACTURING NONCONFORMANCE WOULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT. ADDITIONALLY, A REVIEW OF THE IFU AND TRAINING MANUAL REVEALED NO DEFICIENCIES. THE COMPLAINT DESCRIPTION STATES THAT CALCIUM WAS PRESENT IN THE SINOTUBULAR JUNCTION (STJ). THE PATIENT IMAGERY PROVIDED CONFIRMS THE PRESENCE OF CALCIUM AT BOTH THE IMPLANT SITE AND WITHIN THE ACCESS VASCULATURE. CALCIFICATION CAN DIRECTLY GET INTO CONTACT WITH THE BALLOON DURING INFLATION, CREATING AN ALTERED BALLOON PROFILE UPON INFLATION. AS A RESULT OF THE CALCIFICATION, THE PRESSURE AGAINST THE BALLOON BECOMES NON-UNIFORM ACROSS ITS SURFACE, MAKING IT MORE PRONE TO HOLES/TEARS AND RESULTING IN LEAKAGE/BURSTING. A LEAK IN THE BALLOON COULD INDEED BE RESPONSIBLE FOR THE PARTIAL DEPLOYMENT OF THE VALVE, AS STATED IN THE EVENT DESCRIPTION. HOWEVER, WITHOUT THE RETURNED DEVICE TO EVALUATE, THE ROOT CAUSE CANNOT BE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, IT IS LIKELY THAT PATIENT FACTORS (CALCIFICATION) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. SINCE NO EDWARDS DEFECTS WERE IDENTIFIED, NO CORRECTIVE/PREVENTATIVE ACTIONS ARE REQUIRED. ADDITIONALLY, SINCE NO MANUFACTURING NON-CONFORMANCES OR IFU/TRAINING MANUAL DEFICIENCIES WERE IDENTIFIED AND THE COMPLAINT RATE DID NOT EXCEED THE TREND CATEGORY CONTROL LIMIT, NO ESCALATION TO A PRA WAS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED, DURING A TF TAVR CASE, DURING VALVE DEPLOYMENT A PIN HOLE LEAK PROXIMAL TO THE BALLOON SHOULDER APPEARED, RESULTING IN THE VALVE BEING 75% DEPLOYED. POST-DILATION OF THE VALVE WAS NECESSARY. IT IS BELIEVED THAT CALCIUM IN THE STJ CAUSED THE HOLE IN THE BALLOON. THE PATIENT IS FINE, THERE WAS NO ADVERSE OUTCOME, JUST A SMALL PROCEDURAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976910 EDWARDS COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600LDS26A 62372201

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR