BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 6028805 · Received October 13, 2016

    Report

    Report Number
    2015691-2016-03034
    Event Type
    Death
    Date Received
    October 13, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 16, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMMANDER DELIVERY SYSTEM AND/OR APPLICABLE PHOTOGRAPHS WERE NOT RETURNED TO EDWARDS FOR EVALUATION, THEREFORE, THE COMPLAINT OF ¿DELIVERY SYSTEM, WITHDRAWAL DIFFICULTY ¿ VALVE, THROUGH SHEATH¿ WAS UNABLE TO BE CONFIRMED. A REVIEW OF COMPLAINT HISTORY ANALYSIS, AND MANUFACTURING MITIGATIONS DID NOT REVEAL ANY INDICATIONS THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINT EVENT. WITHOUT THE DEVICE RETURNED FOR EVALUATION, VISUAL INSPECTION, FUNCTIONAL TESTING AND DIMENSIONAL ANALYSIS WERE UNABLE TO BE COMPLETED AND THEREFORE, THE TRUE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. IT SHOULD BE NOTED THAT DURING MANUFACTURING OF THE COMMANDER DELIVERY SYSTEM AND ESHEATH, MULTIPLE 100% INSPECTIONS ARE PERFORMED. THESE INSPECTIONS MAKE IT UNLIKELY THAT A DEFECT PRESENT IN MANUFACTURING CONTRIBUTED TO THE COMPLAINT. WITHDRAWAL OF THE DELIVERY SYSTEM WITH A CRIMPED VALVE CAN BE AFFECTED BY PROCEDURAL FACTORS SUCH AS WITHDRAWAL ANGLE, NOT PLACING THE FLEX TIP OVER THE TRIPLE MARKER PRIOR TO WITHDRAWAL, NON-COAXIALITY OF THE COMPONENTS BEING RETRIEVED (DELIVERY SYSTEM, VALVE, AND SHEATH) AND LARGER THV PROFILE DUE TO THE VALVE LOCATION ON THE BALLOON (CRIMPED THV ALIGNED ON BALLOON IS LARGER THAN CRIMPED THV OFF BALLOON). PER THE CER, ¿THE EDGE OF THE STENT FRAME CAUGHT THE ARCHITECTURE OF THE VESSEL AT THE CURVATURE OF THE SUBCLAVIAN ARTERY¿. THE FRAME GETTING CAUGHT ON ANATOMY IN THIS MANNER COULD ALSO RESULT IN WITHDRAWAL DIFFICULTY. IN ADDITION, THE CURVATURE OF THE SUBCLAVIAN ARTERY, DESCRIBED AS BEING OUTSIDE THE SHEATH TIP IN THE CER, COULD LEAD TO NON-COAXIALITY OF THE THV AND ESHEATH DURING RETRIEVAL. NO MANUFACTURING OR IFU/LABELING INADEQUACIES WERE IDENTIFIED. AVAILABLE INFORMATION SUGGESTS THAT PATIENT/PROCEDURAL FACTORS CONTRIBUTED TO THE COMPLAINT. REVIEW OF COMPLAINT HISTORY FOR (B)(6) 2016 REVEALED THAT THE OCCURRENCE RATE DOES NOT EXCEED THE CONTROL LIMITS FOR THIS TREND CATEGORY. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED, DURING A SUBCLAVIAN TAVR PROCEDURE IN THE AORTIC POSITION, DURING VALVE ALIGNMENT THE PATIENT BECAME HYPOTENSIVE AND WAS PLACED ON BYPASS PUMP. THE DELIVERY SYSTEM/VALVE WERE ATTEMPTED TO BE REMOVED, HOWEVER, THE PHYSICIAN MET RESISTANCE IN THE SUBCLAVIAN AND A DECISION WAS MADE TO PROCEED AND IMPLANT THE 29MM SAPIEN VALVE. THE SAPIEN 3 VALVE WAS SUCCESSFULLY IMPLANTED IN THE AORTIC ANNULUS. THE POST DEPLOYMENT ANGIOGRAPHY REVEALED A ¿VASCULAR TEAR¿ IN THE LEFT SUBCLAVIAN, AT THE ACCESS SITE. A GORE BOND STENT WAS SUCCESSFULLY PLACED ACROSS THE PERFORATION. THE PATIENT DID NOT RECOVER FROM INITIALLY BEING PLACED ON BYPASS PUMP AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676366 EDWARDS COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600LDS29

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| R