BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INTUITY ELITE VALVE SYSTEM

    MDR report key: 9367769 · Received November 25, 2019

    Report

    Report Number
    2015691-2019-04387
    Event Type
    Injury
    Date Received
    November 25, 2019
    Date of Event
    November 1, 2019
    Report Date
    November 1, 2019
    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

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 0

    DEVICE CODE 3191 - DEHISCENCE. ADDITIONAL MANUFACTURER NARRATIVE: UDI # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 23MM AORTIC VALVE, IMPLANTED FOR SEVEN (7) MONTHS, WAS EXPLANTED DUE TO PERIVALVULAR LEAK AND DEHISCENCE. THE EXPLANTED DEVICE WAS REPLACED WITH A 27MM VALVE. THE PATIENT WAS TAKEN TO THE ICU IN STABLE CONDITION. THE PATIENT WAS DISCHARGED ON POD #3 IN STABLE CONDITION PER RECORDS, THIS CASE INVOLVED A 59 YEAR OLD MALE DIAGNOSED WITH AORTIC STENOSIS DUE TO A BICUSPID AORTIC VALVE. THE PATIENT UNDERWENT AVR WITH A 23MM VALVE. THE PATIENT FELT WELL FOR ABOUT FOUR WEEKS AND THEN BECOME PROGRESSIVELY SHORT OF BREATH AND WAS DIAGNOSED WITH A SEVERE PERIVALVULAR LEAK OF THE AORTIC VALVE. THERE WERE THREE ATTEMPTS TO INSERT AMPLATZER PLUGS AROUND THE VALVE TO STOP THE PERIVALVULAR LEAK; HOWEVER, THIS WAS UNSUCCESSFUL. THE PATIENT WAS REFERRED TO SURGERY. INTRAOPERATIVELY, A LARGE DEHISCENCE APPROXIMATELY HALF THE CIRCUMFERENCE OF THE VALVE WAS FOUND UNDER THE RIGHT CORONARY OSTIA. THE PREVIOUS VALVE WAS REMOVED AND A 27MM VALVE WAS IMPLANTED IN REPLACEMENT. THE PATIENT WAS TAKEN TO THE ICU IN STABLE CONDITION. THE PATIENT WAS DISCHARGED ON POD #3 IN STABLE CONDITION. SURGEON HAS PERFORMED OVER 100 EIE CASES.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION ARE IN PROCESS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWS THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. BASED ON THE INFORMATION RECEIVED THE CAUSE OF THE EVENT CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. EDWARDS LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 23 MM AORTIC VALVE, IMPLANTED FOR SEVEN (7) MONTHS, WAS EXPLANTED DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH AN 11500A 27 MM VALVE. OUTCOME WAS GREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167795 EDWARDS INTUITY ELITE VALVE SYSTEM TISSUE, HEART-VALVE LWR EDWARDS LIFESCIENCES 8300AB

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention