BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 18361729 · Received December 20, 2023

    Report

    Report Number
    2015691-2023-18573
    Event Type
    Injury
    Date Received
    December 20, 2023
    Date of Event
    May 3, 2022
    Report Date
    January 11, 2024
    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

    BASED ON THE INFORMATION RECEIVED, THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE EDWARDS DEVICES OR THAT THE USE OR MISS-USE OF THE DEVICES CAUSED OR CONTRIBUTED TO A PATIENT INJURY OR DEATH, AS THIS ARTICLE DID NOT INVOLVE REAL PATIENTS. THE EVENT OCCURRED IN AN EX-VIVO MODEL. ADDITIONALLY, THERE WERE NO ALLEGATIONS OF DEFICIENCIES RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS OR PERFORMANCE OF THESE EDWARDS DEVICES. AS SUCH, THIS EVENT DO NOT MEET THE CRITERIA FOR A COMPLAINT AND THIS CORRECTION IS BEING SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE: THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS ARTICLE. REFER TO MEDWATCH NUMBER 40604 FOR ADDITIONAL EVENTS WITHIN THE SAME ARTICLE. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE DATE OF THE EVENT IS UNKNOWN; HOWEVER, THE ARTICLE WAS RECEIVED FOR PUBLICATION ON 3TH OF MAY 2022. THEREFORE, THE DATE THE ARTICLE WAS RECEIVED FOR PUBLICATION WAS USED AS THE OCCURRENCE DATE. ARTICLE CITATION: GIANNINI F, KHOKHAR AA, CURIO J, ZLAHODA-HUZIOR A, MIKHAIL G, DUDEK D. CORONARY ACCESS AND PCI AFTER CHIMNEY STENTING DURING SELF-EXPANDING TRANSCATHETER AORTIC VALVE REPLACEMENT IN SURGICAL BIOPROSTHESIS. JACC CARDIOVASC INTERV. 2022 AUG 8;15(15):1585-1589. DOI: 10.1016/J.JCIN.2022.05.015. EPUB 2022 JUN 15. PMID: 35717397. 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.

    Description of Event or Problem · 0

    THROUGH REVIEW OF MEDICAL ARTICLE "CORONARY ACCESS AND PCI AFTER CHIMNEY STENTING DURING SELF-EXPANDING TRANSCATHETER AORTIC VALVE REPLACEMENT IN SURGICAL BIOPROSTHESIS", THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE. A PATIENT WITH A 25MM PERIMOUNT VALVE IMPLANTED IN THE AORTIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION DUE TO STRUCTURAL VALVE DETERIORATION. A NON-EDWARDS TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED WITHIN THE SURGICAL VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050060 NI REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R| H