BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASCENDRA BALLOON AORTIC

    MDR report key: 5889413 · Received August 19, 2016

    Report

    Report Number
    2015691-2016-02560
    Event Type
    Death
    Date Received
    August 19, 2016
    Date of Event
    July 28, 2016
    Report Date
    July 28, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. ACCORDING TO THE THV TRAINING MANUALS, RISK FACTORS FOR AORTIC DISSECTION, HEMATOMA OR ANNULAR RUPTURE DURING THE TAVR PROCEDURE INCLUDE SIGNIFICANT THV OVER SIZING, SEVERELY OBLITERATED SINUSES OF VALSALVA, PORCELAIN AORTA AND/OR PRESENCE OF BULKY CALCIFICATION AND NARROW CALCIFIED STJ. IN ADDITION, ADVANCED AGE, FEMALE GENDER, SMALL BODY WEIGHT, AND STEROID DEPENDENCY CAN ALSO BE CONTRIBUTING FACTORS. THE SAPIEN VALVE RELIES ON NATIVE VALVE CALCIUM TO SECURELY ANCHOR TO THE ANNULUS. DESPITE THIS BENEFICIAL ASPECT OF CALCIUM, BULKY CALCIUM CAN INCREASE THE RISK OF CALCIFIC NODULE DISPLACEMENT INTO THE VASCULATURE, WHICH CAN LEAD TO VASCULAR INJURY. AT TIMES THE EXTENT AND DISTRIBUTION OF CALCIUM CAN IMPAIR EASE OF DELIVERY OF THE VALVE, CORRECT POSITIONING OF THE VALVE, DEPLOYMENT OF THE VALVE AND PROCEDURAL SUCCESS. IN THIS CASE, THE REPORTED CAUSE OF THE EVENT WAS DUE TO A HEAVILY CALCIFIED ANNULUS. 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, 26MM SAPIEN XT VALVE IMPLANTATION BY TA APPROACH. THE APICAL ACCESS WENT WELL AND THE E-SHEATH INSERTION WAS WITHOUT ISSUE. BAV WAS PERFORMED WITH THE 20X3 EW BALLOON AND THE PATIENT BECAME HYPOTENSIVE AND THE FLUORO INJECTION SHOWED SEVERE AI AFTER THE BAV. THE PREPARED VALVE WAS QUICKLY INSERTED AND CROSSED THE ANNULUS EASILY. POSITION UNDER FLUORO LOOKED GOOD AND THE VALVE WAS INFLATED SLOWLY USING SUBSEQUENT CONTRAST INJECTION AND FLUORO. THE VALVE IMMEDIATELY MOVED INTO THE VENTRICLE AT THE BEGINNING OF INFLATION BUT WAS QUICKLY RECOVERED AND INFLATION CONTINUED. THE VALVE LOOKED TO BE IN A GOOD POSITION IMMEDIATELY POST DEPLOYMENT BUT THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA REQUIRING DEFIBRILLATION AND HEMODYNAMICS DID NOT RECOVER. THE PATIENT WAS GIVEN VASOPRESSORS AND REPEATED DEFIBRILLATION WAS REQUIRED. ANOTHER FLOURO UNDER CONTRAST SHOWED A LARGE EFFUSION BENEATH THE LEFT MAIN WHICH PROVED TO BE AN ANNULAR RUPTURE. UNFORTUNATELY, THE PATIENT DETERIORATED RAPIDLY AND EXPIRED ON THE TABLE. FURTHER REVIEW OF THE IMAGES SHOWED A VERY SMALL CONTRAST STAIN BESIDE THE LEFT CUSP AFTER BAV AND BEFORE THE VALVE WAS DEPLOYED THAT WENT UNNOTICED AT THE TIME. AS PER MEDICAL OPINION, THE ANNULUS WAS HEAVILY CALCIFIED AND THE BAV CAUSED THE INITIAL DAMAGE TO THE ANNULUS THAT WAS EXACERBATED WHEN THE VALVE WAS DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543509 ASCENDRA BALLOON AORTIC AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100BAVC 60378608

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| R