BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INTUITY ELITE VALVE SYSTEM AORTIC VALVE

    MDR report key: 8217736 · Received January 4, 2019

    Report

    Report Number
    2015691-2019-00059
    Event Type
    Injury
    Date Received
    January 4, 2019
    Date of Event
    December 10, 2018
    Report Date
    December 10, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P150036  
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA: 20-00141.

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORT OF "PVL AND IMPROPER SEATING" COULD NOT BE CONFIRMED THROUGH VISUAL OBSERVATIONS. THE X-RAY DEMONSTRATED WIREFORM INTACT AND FRAME EXPANDED. A SUTURE HOLE WAS VISIBLE NEAR ONE OF THE BLACK STITCH MARKINGS ON THE SEWING RING. THE HOLDER AND BALLOON INTRODUCER WERE RETURNED CONNECTED TO EACH OTHER, AND DETACHED FROM THE VALVE. THE DELIVERY SYSTEM WAS ALSO RETURNED; NO VISIBLE INCONSISTENCIES WERE OBSERVED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). PARAVALVULAR LEAK (PVL) REFERS TO BLOOD FLOWING THROUGH A CHANNEL BETWEEN THE STRUCTURE OF THE IMPLANTED VALVE AND THE CARDIAC TISSUE. IT MAY OCCUR AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE AT THE ANNULUS. THE MOST COMMON REASON FOR PVL IS INADEQUATE DEBRIDEMENT OF A CALCIFIED ANNULUS OR ATTEMPTED IMPLANT WITH IMPROPER VALVE SEATING. PVL IS NOT A RESULT OF DEVICE MALFUNCTION. IN THIS CASE, IT WAS REPORTED THE PATIENT WAS LEFT ON BALLOON PUMP AND ECMO. THE PATIENT WAS REPORTED TO HAVE EXPIRED AND THE PVL AND VALVE CONTRIBUTED TO THE EVENT. NO ADDITIONAL DETAILS WERE PROVIDED. THE ROOT CAUSE REMAINS INDETERMINABLE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON PRODUCT EVALUATION COMPLETION AND DEVICE HISTORY RECORDS REVIEW COMPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 25MM PERICARDIAL AORTIC VALVE WAS EXPLANTED AT IMPLANT DUE TO PERIVALVULAR LEAK (PVL) AND IMPROPER SEATING. A 25MM PERICARDIAL AORTIC VALVE WAS IMPLANTED. THE PATIENT LEFT ON A BALLOON PUMP AND ECMO. THE PATIENT WAS REPORTED TO HAVE EXPIRED. IT WAS ALSO NOTED THAT THE PVL AND VALVE CONTRIBUTED TO THE EVENT. IT WAS REPORTED THAT THIS WAS THE SURGEON'S FIRST EIE CASE. THIS WAS AN AVR+CABG CASE. THE PATIENT HAD TRICUSPID VALVE; HOCKEY STICK APPROACH AND SIZERS 23MM, 25MM, AND 27MM WERE USED; THE SHAPE OF THE NATIVE ANNULUS WAS ROUND; NORMAL DEBRIDEMENT WAS PERFORMED; SIMPLE SUTURE TECHNIQUE WAS EMPLOYED. SEATING WAS VERY EASY. A GAP WAS NOTICED AFTER DELIVERY SYSTEM WAS REMOVED AND A PLEDGET SUTURE WAS USED. WHEN CLAMP WAS REMOVED THE LV KEPT FILLING UP AND ECHO WAS PERFORMED. BASED ON THE EVALUATION OF THE ECHO SHOWING A PVL (PRIOR TO PROTAMINE ADMINISTRATION) WITH LOW FLOW AND THE FILLING OF THE LV. THE SURGEON OPTED TO REMOVE THE VALVE AND REPLACE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9667 EDWARDS INTUITY ELITE VALVE SYSTEM AORTIC VALVE REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 8300AB25

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R