BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 3130779 · Received May 24, 2013

    Report

    Report Number
    2015691-2013-20172
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 28, 2013
    Report Date
    April 28, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE SUBJECT DEVICE HAS NOT BEEN RETURNED AS THE REPORTED INFORMATION SUGGEST NOTHING TO INDICATE AN EXPLANT OR INTERVENTION HAD OCCURRED. IT WAS LEARNED THAT THE PATIENT EXPIRED PRIOR TO EVALUATION FOR THE VALVE IN VALVE PROCEDURE. NO INFORMATION TO SUGGEST A DEVICE RELATIONSHIP TO THE PATIENT'S DEATH. STENOSIS OF AN IMPLANTED VALVE, LIKE REGURGITATION, MAY BE A MANIFESTATION OF STRUCTURAL VALVE DETERIORATION. THERE ARE CASES OF SVD THAT RESULT IN A COMBINATION OF REGURGITATION AND STENOSIS. WITHOUT RETURN OF DEVICE, THE NATURE AND TYPE OF THE REPORTED DEGENERATION CANNOT BE EVALUATED. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY RELATED TO THIS EVENT. ADDITIONAL INFORMATION WILL BE REPORTED ONCE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY CLINICAL AFFAIRS THAT A (B)(6) FEMALE PATIENT WAS DIAGNOSED WITH SEVERE AORTIC REGURGITATION AND STENOSIS OF AN IMPLANTED EDWARDS AORTIC BIOPROSTHETIC VALVE. THE PATIENT WAS BEING CONSIDERED FOR ENROLLMENT TO UNDERGO A TRANSCATHETER VALVE-IN-VALVE PROCEDURE. IT WAS ALSO LEARNED THAT THE PATIENT IS HOSPITALIZED, INTUBATED, WITH POSSIBLE SEPSIS AND THEREFORE IS BEING DELAYED FOR PRESENTATION FOR TRIAL. UPDATE FROM CLINICAL AFFAIRS THAN INDICATES THE PATIENT EXPIRED (B)(6) 2013. NO INDICATION OF AN INTERVENTION OR EXPLANT FOR THE PREVIOUSLY IMPLANT SUBJECT VALVE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232096 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| H| L| R