BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 5490167 · Received March 9, 2016

    Report

    Report Number
    2015691-2016-00726
    Event Type
    Injury
    Date Received
    March 9, 2016
    Date of Event
    February 5, 2016
    Report Date
    February 19, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PER THE DOCTOR, THERE WAS CALCIFICATION IN THE LVOT WHICH PERFORATED.

    Additional Manufacturer Narrative · 1

    THE IFU LISTS CARDIOVASCULAR INJURY THAT MAY REQUIRE INTERVENTION (INCLUDING PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, ANNULAR TEAR OR RUPTURE) AS A POTENTIAL RISK ASSOCIATED WITH THE OVERALL TAVR PROCEDURE. AORTO-CARDIAC OR INTRA-CARDIAC FISTULAS AND SHUNTS ARE RELATIVELY RARE BUT CAN RESULT FROM ENDOCARDITIS, TISSUE TRAUMA OR RUPTURE OF CARDIAC ANEURYSMS. THEY HAVE BEEN REPORTED AS A RARE COMPLICATION FOLLOWING SURGICAL OR TRANSCATHETER AORTIC VALVE REPLACEMENT. THIS TYPE OF DEFECT IN THE CARDIAC TISSUES OR AORTIC WALL CAN RESULT FROM TRAUMA DURING PERCUTANEOUS AORTIC VALVE IMPLANTATION, ADDITIONAL IN-VALVE BALLOON DILATION ON A HEAVILY CALCIFIED NATIVE AORTIC VALVE, OR TISSUE EROSION OVER TIME FROM CALCIFIED VEGETATIONS OR THE VALVE FRAME. PERCUTANEOUS OR SURGICAL CLOSURE OF PARAPROSTHETIC LEAKS MAY BE REQUIRED TO CLOSE THE COMMUNICATION. IN THIS CASE, THE VSD WAS LIKELY A RESULT OF VALVE DEPLOYMENT AND THE VALVE FRAME CONTACTING THE LVOT, WHICH REQUIRED INTERVENTION VIA A SEPTAL OCCLUSION 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, POST IMPLANT OF A SAPIEN 3 VALVE, POST DILATION WITH A 28MM NUCLEUS BALLOON WAS DONE DUE TO AORTIC INSUFFICIENCY. FINAL RESULT AI MILD TO MODERATE. 16 DAYS POST IMPLANT, A HEMODYNAMIC RELEVANT VSD WAS DIAGNOSED IN TEE AND CT. THE VSD WAS CLOSED WITH A VSD OCCLUDE 12MM 4 DAYS LATER. UNFORTUNATELY A RELEVANT LEFT-RIGHT SHUNT REMAINS IMMEDIATELY BELOW THE SAPIEN 3 VALVE, RESPECTIVELY A BIT LOWER INTO THE LVOT. A NEW CT WAS MADE AND THE PATIENT REMAINS IN INTENSIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144902 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX29

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention