BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 6043498 · Received October 20, 2016

    Report

    Report Number
    2015691-2016-03108
    Event Type
    Death
    Date Received
    October 20, 2016
    Date of Event
    September 21, 2016
    Report Date
    September 28, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION DISSECTION OF VESSELS, INJURIES TO THE VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. ACCORDING TO THE THV TRAINING MANUALS, RISK FACTORS FOR CARDIOVASCULAR INJURIES DURING THE TAVR PROCEDURE INCLUDE SIGNIFICANT THV OVER SIZING, SEVERELY OBLITERATED SINUSES OF VALSALVA, DELIVERY SYSTEM MANIPULATION, PORCELAIN AORTA AND/OR PRESENCE OF BULKY CALCIFICATION, DISEASED VENTRICLES 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 CARDIOVASCULAR 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. VENTRICULAR ANEURYSM IS THE BALLOONING OF TISSUE WITHIN THE WALLS OF THE VENTRICLE. THIS MAY OCCUR DUE TO TEARING OF THE VENTRICULAR WALL OR MECHANICAL INJURY DURING BAV, DELIVERY SYSTEM MANIPULATION OR VALVE DEPLOYMENT. IF THE ANEURYSM REMAINS STABLE, WITH NO OBSTRUCTION OR SIGNIFICANT DECREASE IN CARDIAC FUNCTION AND/OR WITHOUT PERICARDIAL EFFUSION, INTERVENTION MAY OR MAY NOT BE NEEDED. IN THIS CASE, THE ANEURYSM DID NOT REQUIRE INTERVENTION, HOWEVER, THE PATIENT SUBSEQUENTLY PASSED AWAY FIVE HOURS POST PROCEDURE. ALTHOUGH THE CAUSE OF DEATH IS UNKNOWN, THIS EVENT WILL BE REPORTED CONSERVATIVELY. 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 OUR AFFILIATES IN (B)(4), AFTER A SUCCESSFUL IMPLANT OF A 26 MM SAPIEN 3 VALVE BY TF APPROACH IN AORTIC POSITION, AN ANEURYSM WAS DETECTED IN THE SEPTUM. NO ACTIONS WERE TAKEN AND PATIENT WAS IN STABLE CONDITIONS IN ICU. UNFORTUNATELY, PATIENT PASSED AWAY FIVE HOURS AFTER PROCEDURE. AS PER MEDICAL OPINION IT IS NOT KNOWN THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696262 EDWARDS COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9610TF23 60513589

    Patients

    Seq Age Sex Outcome Treatment
    1 Death