BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

    MDR report key: 7442120 · Received April 18, 2018

    Report

    Report Number
    2015691-2018-01448
    Event Type
    Injury
    Date Received
    April 18, 2018
    Date of Event
    March 8, 2018
    Report Date
    April 3, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE VALVE WAS NOT RETURNED TO EDWARDS LIFESCIENCES, AS IT REMAINS IMPLANTED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE, HOWEVER, THE INFORMATION WAS NOT FORTHCOMING. 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, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT.  THE CAUSE OF THE CARDIAC TAMPONADE IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    THE VALVE MODEL NUMBER WAS NOT PROVIDED THEREFORE THE FOLLOWING INFORMATION IS BEING PROVIDED AS REFERENCE: BRAND NAME: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE/MODEL: 9300TFX/ PMA: P130009 OR BRAND NAME: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE/MODEL: 9600TFX/PMA: P140031.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS AFFILIATE IN KOREA, TWENTY NINE DAYS POST TRANSFEMORAL TAVR PROCEDURE IN THE AORTIC POSITION, A PERICARDIAL EFFUSION LEADING TO TAMPONADE OCCURRED.  A PCC WAS INSERTED AND REMOVED SIX DAYS LATER.  A TOTAL OF 2 UNITS OF RBC WERE TRANSFUSED, MEDICATION WAS GIVEN AND PERICARDIAL PUNCTURE WAS DONE.  THE EVENT WAS RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282881 AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention