BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS

    MDR report key: 16850214 · Received May 1, 2023

    Report

    Report Number
    2015691-2023-12692
    Event Type
    Injury
    Date Received
    May 1, 2023
    Date of Event
    April 5, 2023
    Report Date
    June 22, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    UDI-DI
    00690103021622
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 SECTIONS: B5, B7, G3, G6, H6 COMPONENT CODE, HEALTH EFFECT - CLINICAL CODE, AND DEVICE CODE(S).

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS: B4, D4 (EXPIRATION DATE), G3, G6, H2, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS). THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. THERE WERE NO ISSUES IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. STENOSIS, WHICH DEVELOPS PROGRESSIVELY OVER TIME, CAN BE DUE TO A NUMBER OF ISSUES. ADDITIONALLY, THERE CAN BE A NUMBER OF POTENTIALS KNOWN AND UNKNOWN PATIENT-RELATED CONTRIBUTING FACTORS. PER TECHNICAL SUMMARY 33069, REV A, STRUCTURAL VALVE DETERIORATION (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, OCCURRING SINGULARLY OR CONCOMITANTLY, MAY CONTRIBUTE TO STENOSIS AND/OR REGURGITATION. ALTERNATIVELY, NON-STRUCTURAL VALVE DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR STENOSIS. STENOSIS 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 HLD AND ATHEROSCLEROSIS. ALL PERTINENT INFORMATION AVAILABLE TO EDWARDS LIFESCIENCES HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A 27MM 2700 AORTIC VALVE UNDERWENT VALVE IN VALVE PROCEDURE AFTER IMPLANT DURATION OF 7 YEARS 3 MONTHS DUE TO UNKNOWN REASON. THE TAVR PROCEDURE WAS PERFORMED SUCCESSFULLY WITH 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT POST-PROCEDURE IN RECOVERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A 27MM 2700 AORTIC VALVE UNDERWENT VALVE IN VALVE PROCEDURE AFTER IMPLANT DURATION OF 7 YEARS 3 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH, AND FATIGUE. THE TAVR PROCEDURE WAS PERFORMED SUCCESSFULLY WITH 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT POST-PROCEDURE IN RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1800449 CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES 2700 00690103021622

    Patients

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