BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 17142186 · Received June 16, 2023

    Report

    Report Number
    2015691-2023-13920
    Event Type
    Injury
    Date Received
    June 16, 2023
    Date of Event
    May 29, 2022
    Report Date
    July 18, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTION B4 (DATE OF THIS REPORT), G3 (DATE RECEIVED BY MANUFACTURER), H6 (TYPE OF INVESTIGATION), H6 (INVESTIGATION FINDINGS) AND H6 (INVESTIGATIONS CONCLUSIONS). CORRECTED DATA: THE DATE OF THE EVENT IS UNKNOWN. THEREFORE, DATE ARTICLE WAS RECEIVED FOR PUBLICATION (29 MAR 2022) WAS USED AS THE DATE OF EVENT. H10: ADDITIONAL MANUFACTURER NARRATIVE: THE SERIAL NUMBER WAS NOT PROVIDED. THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE DEVICE WAS NOT RETURNED FOR EVALUATION, NO DETAILS REGARDING WHAT ISSUE WARRANTED THE INTERVENTION, OR WHAT COMORBIDITIES THE PATIENT HAD, WERE PROVIDED. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF THREE INITIAL MANUFACTURER REPORTS (31857, 31861 AND 31865) BEING SUBMITTED FOR THIS ARTICLE. THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS, MODEL# 6625LP, PMA# P870077. ARTICLE CITATION: TZIMAS G, HAUGAN D, AKODAD M, SATHANANTHAN J, MEIER D, QANADLI SD, WEBB JG, BLANKE P. COMPUTED TOMOGRAPHY REFERENCE DIMENSIONS FOR IDENTIFICATION OF STENTED SURGICAL MITRAL BIOPROSTHESES VALVE SIZE. J CARDIOVASC COMPUT TOMOGR. 2022 NOV-DEC;16(6):517-523. DOI: 10.1016/J.JCCT.2022.07.001. EPUB 2022 JUL 7. PMID: 35872138. THE SUBJECT DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY REMAIN IMPLANTED. IN THIS CASE, THE CUSTOMER WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION ON THESE EVENTS, AS THE RECORDS ARE ANONYMIZED AND NOT READILY AVAILABLE. THEREFORE, NO DETAILS REGARDING WHAT ISSUE WARRANTED THE INTERVENTIONS OR WHAT COMORBIDITIES THE PATIENTS HAD WERE PROVIDED.

    Description of Event or Problem · 0

    THROUGH REVIEW OF MEDICAL ARTICLE " COMPUTED TOMOGRAPHY REFERENCE DIMENSIONS FOR IDENTIFICATION OF STENTED SURGICAL MITRAL BIOPROSTHESES VALVE SIZE" , THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: 6 PATIENTS WITH A VALVE MODEL 6650 IMPLANTED IN MITRAL POSITION UNDERWENT VALVE-IN-VALVE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION DUE TO FAILED BIOPROSTHETIC SURGICAL HEART VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227869 SEE H10 REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES 6650

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R| L