BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER PFO OCCLUDER

    MDR report key: 10136262 · Received June 9, 2020

    Report

    Report Number
    2135147-2020-00264
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Date of Event
    May 14, 2020
    Report Date
    June 9, 2020
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    00811806011288
    PMA / PMN Number
    P120021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF A ROUND, BULBOUS DEPLOYMENT WAS CONFIRMED. FOLLOWING THE SIMULATED DEPLOYMENT, THE BULBOUS SHAPE RETURNED TO NORMAL AND MET FUNCTIONAL SPECIFICATIONS WHEN ANALYZED AT ABBOTT. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL DEFINED MANUFACTURING SPECIFICATIONS AT THE TIME OF RELEASE TO COMMERCIALIZATION. A CAPA WAS INITIATED FOR FURTHER INVESTIGATION AND DID NOT IDENTIFY A PRODUCT QUALITY ISSUE. HOWEVER, CORRECTIVE ACTIONS TO FURTHER ENHANCE PERFORMANCE ARE BEING PURSUED PER INTERNAL OPERATING PROCEDURES.

    Description of Event or Problem · 1

    ON (B)(6) 2020, A 25MM AMPLATZER PFO OCCLUDER(LOT#7348534) WAS SELECTED FOR IMPLANT IN A (B)(6) YEAR-OLD FEMALE. DURING THE PROCEDURE THE DEVICE WAS DEPLOYED, BUT NOT RELEASED BECAUSE THE RIGHT ATRIAL DISC APPEARED BULBOUS SHAPED. THE PHYSICIAN RECAPTURED THE DEVICE AND REDEPLOYED IT TWICE AND ATTEMPTED TO PUSH AND PULL THE DEVICE WHILE IN THE SEPTUM MULTIPLE TIMES, BUT THE DISC WOULD NOT FLATTEN. THE PHYSICIAN THEN REMOVED THE DEVICE FROM THE PATIENT WITHOUT CONSEQUENCE AND EXCHANGED IT FOR A 25MM AMPLATZER CRIBRIFORM OCCLUDER (LOT#7241248). THE CRIBRIFORM DEVICE WAS SUCCESSFULLY DEPLOYED AND IMPLANTED IN THE PATIENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, THERE WAS NO SERIOUS INJURY AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596238 AMPLATZER PFO OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-PFO-025 7348534 00811806011288

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR