BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 17449229 · Received August 3, 2023

    Report

    Report Number
    2015691-2023-15002
    Event Type
    Injury
    Date Received
    August 3, 2023
    Date of Event
    June 1, 2016
    Report Date
    September 7, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    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

    SECTION D1, D4, G5. THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND EDWARDS INTUITY ELITE VALVE SYSTEM MODEL# 8300AB, PMA# P150036. THE DATE OF THE EVENT IS UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE, THE STUDY PERIOD WAS FROM JUNE 2016 TO JULY 2020. THUS, THE FIRST DAY OF THE REPORTED STUDY PERIOD ((B)(6)2016 ) WAS USED AS THE OCCURRENCE DATE. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINED IMPLANTED. ARTICLE CITATION: SUK HO SOHN, KYUNG HWAN KIM, YOONJIN KANG, JI SEONG KIM, JAE WOONG CHOI, RECOVERY FROM CONDUCTION ABNORMALITIES AFTER AORTIC VALVE REPLACEMENT USING EDWARDS INTUITY, THE ANNALS OF THORACIC SURGERY, VOLUME 112, ISSUE 4, 2021, PAGES 1356-1362, ISSN 0003-4975, HTTPS://DOI.ORG/10.1016/J.ATHORACSUR.2021.04.036. 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

    THE SERIAL NUMBER WAS NOT PROVIDED. THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE REASON FOR POST-OPERATIVE AV BLOCK AFTER SURGICAL AVR IS RELATED TO INJURY TO THE CARDIAC CONDUCTION SYSTEM DURING SURGICAL EXCISION OF THE ADJACENT DISEASED VALVE AND ANNULAR TISSUE. THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE VALVULAR COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE EXPLAINS THE POSSIBLE DEVELOPMENT OF CONDUCTION ABNORMALITIES FOLLOWING PROSTHETIC VALVE PROCEDURES. ATRIOVENTRICULAR CONDUCTION DISTURBANCES AFTER TAVR AND AVR ARE ASSOCIATED WITH MANY PATIENT-RELATED AND PROCEDURAL-RELATED FACTORS. THE MECHANISMS OF THE DEVELOPMENT OF HEART BLOCK AFTER TAVR AND SURGICAL AVR ARE WELL DOCUMENTED AND DESCRIBED IN THE LITERATURE. IT IS ALSO DOCUMENTED THAT PRE-EXISTING HEART BLOCK IS COMMON IN PATIENTS UNDERGOING TAVR OR SURGICAL AVR AND ANOTHER 4-6 % WILL DEVELOP POST-OPERATIVE HEART BLOCK, POTENTIALLY REQUIRING A PERMANENT PACEMAKER. A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, PATIENT AND/OR PROCEDURAL FACTORS LIKELY CAUSED OR CONTRIBUTED.

    Description of Event or Problem · 0

    THROUGH REVIEW OF MEDICAL ARTICLE " RECOVERY FROM CONDUCTION ABNORMALITIES AFTER AORTIC VALVE REPLACEMENT USING EDWARDS INTUITY", THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: ONE PATIENT WITH A VALVE MODEL 8300A IMPLANTED IN THE AORTIC POSITION HAD A PERMANENT PACEMAKER (PPM) IMPLANTED ON POST-OPERATIVE DAY 18 DUE TO THIRD-DEGREE AVB EXPERIENCED ON POST-OPERATIVE DAY 6. AS PER AUTHOR'S CONCLUSIONS, THE OUTCOMES MAY BE ATTRIBUTED TO THE IMPLANTATION TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508167 SEE H10 HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 8300A

    Patients

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