BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 14887533 · Received July 1, 2022

    Report

    Report Number
    2015691-2022-06534
    Event Type
    Injury
    Date Received
    July 1, 2022
    Report Date
    August 22, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: 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

    BASED ON THE INFORMATION AVAILABLE, THE DEVICE WAS INTENTIONALLY USED OUTSIDE THE WAY IT WAS DESIGNED AND INTENDED. THE PERFORMANCE, SAFETY, EFFICACY, LONGEVITY, AND DURABILITY OF RINGS AND BIOPROSTHETIC VALVES HAVE NOT BEEN DETERMINED WHEN THE PRODUCT IS USED OUTSIDE THE SCOPE OF ITS INTENDED USE AND/OR ITS STUDIED POPULATION. 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, NONCALCIFIC 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 THE PATIENT'S AGE, VALVE IMPLANT POSITION, LACK OF COMPLIANCE, AND CONGENITAL DISEASE.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED: B4, G3, G6, H2, H6 CORRECTED: B5.

    Description of Event or Problem · 0

    UPON REVIEW OF THE ARTICLE IT WAS LEARNED THAT A PATIENT WITH A 27MM EDWARDS SURGICAL VALVE IN THE PULMONARY POSITION [2022-11418-01] AND 32MM EDWARDS ANNULOPLASTY RING IN THE TRICUSPID POSITION [2022-11418-02] UNDERWENT A PULMONARY VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY ONE (1) YEAR DUE TO SEVERE PULMONARY REGURGITATION. POST-OPERATIVE TEE TWO (2) MONTHS, SIX (6) DAYS FROM THE INITIAL IMPLANT PROCEDURE SHOWED MILD PULMONARY AND TRICUSPID REGURGITATION. 10 MONTHS POST PROCEDURE TTE DEMONSTRATE MILD-MODERATE PULMONARY REGURGITATION AND THICKENED LEAFLETS OF THE PULMONARY VALVE, SUSPECTED TO BE SECONDARY TO THROMBOSIS CAUSED BY A LACK OF COMPLIANCE AND A QUESTIONABLE COAGULOPATHY, ALONG WITH MODERATE TRICUSPID REGURGITATION. CMR AT ONE (1) YEAR POST PROCEDURE SHOWED SEVERE PULMONARY REGURGITATION. AT THIS TIME THE PATIENT WAS EXPERIENCING EXTREME FATIGUE, FLUID RETENTION, AND DYSPNEA WITH MINIMAL EXERTION. THE TPVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 22MM NON-EDWARDS TRANSCATHETER VALVE.

    Description of Event or Problem · 0

    UPON REVIEW OF THE ARTICLE IT WAS LEARNED THAT A PATIENT WITH A 27MM EDWARDS SURGICAL VALVE IN THE PULMONARY POSITION [2022-11418-01] AND 32MM EDWARDS ANNULOPLASTY RING IN THE TRICUSPID POSITION [2022-11418-02] UNDERWENT A PULMONARY VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY ONE (1) YEAR DUE TO SEVERE PULMONARY REGURGITATION. POST-OPERATIVE TEE TWO (2) MONTHS, SIX (6) DAYS FROM THE INITIAL IMPLANT PROCEDURE SHOWED MILD PULMONARY AND TRICUSPID REGURGITATION. 10 MONTHS POST PROCEDURE TTE DEMONSTRATE MILD-MODERATE PULMONARY REGURGITATION AND THICKENED LEAFLETS OF THE PULMONARY VALVE , SUSPECTED TO BE SECONDARY TO THROMBOSIS CAUSED BY A LACK OF COMPLIANCE AND A QUESTIONABLE COAGULOPATHY, ALONG WITH MODERATE TRICUSPID REGURGITATION. CMR AT ONE (1) YEAR POST PROCEDURE SHOWED SEVERE PULMONARY REGURGITATION. AT THIS TIME THE PATIENT WAS EXPERIENCING EXTREME FATIGUE, FLUID RETENTION, AND DYSPNEA WITH MINIMAL EXERTION. THE TPVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 22MM NON-EDWARDS TRANSCATHETER VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2097861 NI REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES NI

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Hospitalization| L| R