BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 15875749 · Received November 29, 2022

    Report

    Report Number
    2015691-2022-09525
    Event Type
    Injury
    Date Received
    November 29, 2022
    Date of Event
    May 1, 2017
    Report Date
    January 5, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: THIS IS ONE OF SIX MANUFACTURER REPORTS BEING SUBMITTED FOR THIS ARTICLE. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE DATE OF THE EVENT IS UNKNOWN. HOWEVER, ACCORDING TO THE LITERATURE ARTICLE, THE STUDY PERIOD WAS FROM MAY 2017 TO MARCH 2021. THUS, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01 MAY 2017) WAS USED AS THE DATE OF EVENT. ARTICLE CITATION: NEUSER J, KEMPF T, BAUERSACHS J, WIDDER JD. NOVEL SELF EXPANDING ALLEGRA TRANSCATHETER AORTIC VALVE FOR NATIVE AORTIC STENOSIS AND DEGENERATED BIOPROSTHESIS. CATHETER CARDIOVASC INTERV. 2021 (1 TO 9). 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

    H10: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTION G1 (CONTACT OFFICE). INFORMATION ADDED TO H6 (TYPE OF INVESTIGATION), H6 (INVESTIGATION FINDINGS) AND H6 (INVESTIGATIONS CONCLUSIONS). THIS IS ONE OF SIX MANUFACTURER REPORTS BEING SUBMITTED FOR THIS ARTICLE. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, THE CUSTOMER WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION ON THIS EVENT. THE SERIAL NUMBER WAS NOT PROVIDED. THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. 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. A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, PATIENT FACTORS LIKELY CONTRIBUTED.

    Description of Event or Problem · 0

    THROUGH REVIEW OF MEDICAL ARTICLE " NOVEL SELF-EXPANDING ALLEGRA TRANSCATHETER AORTIC VALVE FOR NATIVE AORTIC STENOSIS AND DEGENERATED BIOPROSTHESIS" , THE FOLLOWING WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: A VALVE-IN-VALVE PROCEDURE WAS PERFORMED WITHIN A 27MM EDWARDS VALVE IMPLANTED IN THE AORTIC POSITION AFTER AN UNKNOWN IMPLANT DURATION DUE TO DEGENERATION LEADING TO SEVERE (GRADE III) STENOSIS AND MILD REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2514583 NI REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES NI

    Patients

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