BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 17277993 · Received July 7, 2023

    Report

    Report Number
    2015691-2023-14408
    Event Type
    Injury
    Date Received
    July 7, 2023
    Date of Event
    June 15, 2023
    Report Date
    September 1, 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

    H10: ADDITIONAL MANUFACTURER NARRATIVE: THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL#: 6625-LP; BRAND NAME: CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS; PMA#: P870077. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. 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

    UPDATED SECTION H6 (INVESTIGATION FINDINGS) AND H6 (INVESTIGATIONS CONCLUSIONS) 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 AS IT REMAINED IMPLANTED AFTER THE VALVE-IN-VALVE (VIV) PROCEDURE, THEREFORE CUSTOMER REPORT OF DEGENERATION/DETERIORATION COULD NOT BE CONFIRMED BY PRODUCT EVALUATION TISSUE DEGENERATION-RELATED STRUCTURAL DETERIORATION, EITHER CALCIFIC OR NON-CALCIFIC, ARE COMMON CHRONIC FAILURE MODES FOR THIS TYPE OF BIOPROSTHETIC HEART VALVE. OPERATIONAL MECHANICAL STRESS AND BIOLOGICAL FACTORS ARE GENERALLY BELIEVED TO BE THE MAJOR CONTRIBUTORS TO THE NON-CALCIFIC BIOPROSTHETIC TISSUE DEGENERATION. STRUCTURAL VALVE DETERIORATION (SVD) CAN, AND TYPICALLY DOES, LEAD TO CHRONIC CENTRAL LEAKS OVER A PERIOD OF TIME. SVD IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANT 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. DEGENERATION-RELATED STRUCTURAL DETERIORATION IS MOST COMMONLY RELATED TO PATIENT FACTORS AND IS NOT USUALLY AN INDICATION OF A DEVICE MALFUNCTION. THE MOST LIKELY CAUSE IS PATIENT FACTORS, INCLUDING RENAL INSUFFICIENCY.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION THAT A 75-YEAR-OLD PATIENT WITH A SAV PORCINE VALVE MODEL 665027MM IMPLANTED IN THE MITRAL POSITION UNDERWENT A VALVE-IN-VALVE (VIV) PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY NINE (9) YEARS AND FIVE (5) MONTHS DUE TO DEGENERATION LEADING TO STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH BEFORE THE VIV PROCEDURE. A 26MM TRANSCATHETER HEART VALVE WAS SUCCESSFULLY IMPLANTED WITHIN THE PRE-EXISTING EDWARDS SURGICAL DEVICE WITH NO REPORTED COMPLICATION FOR THE PATIENT WHO WAS NOTED AS TO BE DOING WELL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2056187 SEE H10 REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES 6650

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Life Threatening| R| H