BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER PFO OCCLUDER

    MDR report key: 12277234 · Received August 4, 2021

    Report

    Report Number
    2135147-2021-00311
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    July 14, 2021
    Report Date
    September 14, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P120021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON REVIEW, THE AMPLATZER PFO OCCLUDER UNDER MANUFACTURING REPORT NUMBER 2135147-2021-00311 SHOULD NOT HAVE BEEN SUBMITTED AS A MEDICAL DEVICE REPORT (MDR) AS THE EVENT DID NOT INDICATE A MALFUNCTION CAUSED A SERIOUS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN 2018, A 25MM AMPLATZER PFO OCCLUDER WAS IMPLANTED IN A SMALL ATRIAL SEPTAL DEFECT (ASD) NEAR THE PATENT FORAMEN OVALE (PFO). ON AN UNKNOWN DATE, RESIDUAL LEAK WAS OBSERVED FROM THE PFO. THEREFORE, ON (B(6) 2021, A SECOND 25MM AMPLATZER PFO OCCLUDER WAS IMPLANTED BESIDE THE FIRST OCCLUDER WITH RESOLUTION OF THE RESIDUAL LEAK. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND WAS REPORTED TO BE IN STABLE CONDITION POST-OPERATIVELY.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2018, A 25MM AMPLATZER PFO OCCLUDER WAS IMPLANTED IN A SMALL ATRIAL SEPTAL DEFECT (ASD) NEAR THE PATENT FORAMEN OVALE (PFO). ON AN UNKNOWN DATE, RESIDUAL LEAK WAS OBSERVED. THEREFORE, ON (B)(6) 2021, A SECOND 25MM AMPLATZER PFO OCCLUDER WAS IMPLANTED BESIDE THE FIRST OCCLUDER WITH RESOLUTION OF THE RESIDUAL LEAK. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND WAS REPORTED TO BE IN STABLE CONDITION POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169859 AMPLATZER PFO OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL 9-PFO-025

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R