BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

    MDR report key: 9282836 · Received November 5, 2019

    Report

    Report Number
    2024168-2019-13266
    Event Type
    Injury
    Date Received
    November 5, 2019
    Date of Event
    January 1, 2019
    Report Date
    July 22, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DRA
    PMA / PMN Number
    K161985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2019001-PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD. SINCE THIS MEDWATCH WAS PREVIOUSLY FILED, IT MUST REMAIN REPORTABLE; HOWEVER, THIS EVENT WAS PREVIOUSLY REPORTED UNDER MFT # 2024168-2018-05761. THIS EVENT IS A DUPLICATE OF THAT EVENT.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. ARTICLE ATTACHMENT: "TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT WAS REQUIRED AFTER TRANSCATHETER MITRAL VALVE REPAIR: A CASE REPORT¿NA - ATTACHMENT: [CN-011807 ARTICLE.PDF].

    Additional Manufacturer Narrative · 0

    G9: EXEMPTION NUMBER E2019001-PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD. THE DEVICE IS NOT RETURNING FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. "TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT WAS REQUIRED AFTER TRANSCATHETER MITRAL VALVE REPAIR: A CASE REPORT¿.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL 30-DAY MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THIS EVENT WAS PREVIOUSLY FILED UNDER MFR 2024168-2018-05761. THIS EVENT IS A DUPLICATE OF THAT EVENT. PLEASE SEE ABOVE REPORT FOR COMPLETE DETAILS.

    Description of Event or Problem · 0

    THIS IS FILED TO REPORT THE ATRIAL SEPTAL DEFECT (ASD). IT WAS REPORTED THAT AFTER THE MITRACLIP PROCEDURE WAS PERFORMED AN ATRIAL SEPTAL DEFECT (ASD) WAS TREATED WITH A CLOSURE DEVICE. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED "TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT WAS REQUIRED AFTER TRANSCATHETER MITRAL VALVE REPAIR: A CASE REPORT.¿ PLEASE SEE ARTICLE FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075787 MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR DRA ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention