BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 13063521 · Received December 22, 2021

    Report

    Report Number
    2015691-2021-06984
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Report Date
    February 7, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS B5, H6 (INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS) BIOPROSTHETIC TISSUE VALVES CAN DETERIORATE WITH TIME AND EVENTUALLY FAIL CONTRIBUTING TO REGURGITATION AND/OR STENOSIS. STRUCTURAL VALVE DETERIORATION (SVD) IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANTS 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 REGURGITATION AND/OR STENOSIS. IN THIS CASE, MINIMAL INFORMATION REGARDING THIS EVENT WAS RECEIVED AND ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CONDITION OF THE DEVICE, PATIENT'S MEDICAL HISTORY, OR POSSIBLE COMORBIDITIES HAVE BEEN MADE. THE ROOT CAUSE OF THIS EVENT CANNOT BE 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 STRUCTURAL VALVE DETERIORATION AND/OR NONSTRUCTURAL DYSFUNCTION. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT. THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED AS THE REPORTED EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO AN EDWARDS MANUFACTURING DEFICIENCY AND/OR ONE WAS NOT CONFIRMED THROUGH INVESTIGATION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION THAT THIS PATIENT WITH A 290025MM AORTIC VALVE HAS BEEN PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF 10 YEARS AND 6 MONTHS DUE TO UNKNOWN REASON. NO OTHER INFORMATION WAS PROVIDED AT THE TIME OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: NO PLANNED DATE FOR THE PROCEDURE AS ELECTIVE CASES IN THE HOSPITAL ARE PLACED ON HOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966872 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2900

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male