BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 11682034 · Received April 16, 2021

    Report

    Report Number
    2015691-2021-02532
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 23, 2021
    Report Date
    May 11, 2021
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL MANUFACTURER NARRATIVE: THERE IS NO INVESTIGATIONAL EVIDENCE THE SURGICAL VALVE PREMATURELY FAILED/MALFUNCTIONED. CORRECTED DATA: BASED ON THE ADDITIONAL INFORMATION OBTAINED, THIS EVENT IS NO LONGER CONSIDERED REPORTABLE AND THIS CORRECTION IS BEING SUBMITTED.

    Description of Event or Problem · 0

    THERE IS NO INVESTIGATION EVIDENCE THE SURGICAL VALVE PREMATURELY FAILED/MALFUNCTIONED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION IS IN PROCESS. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE DEVICE HISTORY RECORD 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. ALTHOUGH BIOPROSTHETIC VALVES HAVE BEEN PROVEN TO HAVE EXCELLENT LONG TERM DURABILITY, FAILURE DOES OCCUR IN A SMALL NUMBER OF VALVES. REPLACEMENT OF A BIOPROSTHETIC VALVE OVER TIME IS MORE LIKELY DUE TO STRUCTURAL VALVE DETERIORATION (SVD) WHICH OCCURS AS A RESULT OF STENOSIS (FROM CALCIFICATION OR HOST TISSUE OVERGROWTH), DEHISCENCE, FIBROSIS OR NON-CALCIFIC DEGENERATION AND/OR ENDOCARDITIS. THE CAUSE OF THE EVENT CANNOT BE DETERMINED; HOWEVER PATIENT FACTORS AND PROGRESSION OF VALVULAR DISEASE LIKELY IMPACTED THE EVENT. 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.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION A PATIENT WITH A 27MM AORTIC VALVE IMPLANTED 18 YEARS, EIGHT (8) MONTHS, IS BEING EVALUATED FOR POSSIBLE VALVE-IN-VALVE INTERVENTION DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577511 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES LLC 2800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR