BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 8388540 · Received March 4, 2019

    Report

    Report Number
    2015691-2019-00716
    Event Type
    Malfunction
    Date Received
    March 4, 2019
    Date of Event
    February 7, 2019
    Report Date
    February 7, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #2800; BRAND NAME: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS; PMA #P860057/S001. STRUCTURAL VALVE DETERIORATION (SVD) IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANTS/REPLACEMENTS AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR STENOSIS AND/OR REGURGITATION. THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED WITH THE AVAILABLE INFORMATION. HOWEVER, THIS EVENT WAS MOST LIKELY IMPACTED BY THE PROGRESSION OF THE PATIENT¿S UNDERLYING VALVULAR DISEASE PATHOLOGY WITH OR WITHOUT SVD AND/OR NSVD. THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED AS THE REPORTED EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO A MANUFACTURING DEFICIENCY AND/OR ONE WAS NOT CONFIRMED THROUGH INVESTIGATION. EDWARDS LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS LEARNT THROUGH AN INQUIRY RECEIVED FROM A PATIENT THAT HIS AORTIC VALVE MODEL 290025MM WAS NOT CLOSING PROPERLY AFTER AN IMPLANT DURATION OF 16 YEARS AND 5 MONTHS. THE PATIENT IS QUESTIONING IF THE ISSUE COULD BE FIXED WITH A TAVR. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178931 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR