BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER CRIBRIFORM OCCLUDER

    MDR report key: 9891567 · Received March 27, 2020

    Report

    Report Number
    2135147-2020-00098
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Date of Event
    February 28, 2019
    Report Date
    April 26, 2020
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    00811806010298
    PMA / PMN Number
    P000039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION FOR: D10, G4, G7, H2, H3, H6, AND H10. THE REPORTED EVENT OF A ROUND, BULBOUS DEPLOYMENT WAS NOTED UPON INITIAL DEPLOYMENT. 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. THOUGH THE OCCLUDER WAS DETERMINED TO MEET FUNCTIONAL SPECIFICATIONS WITH NO ROOT CAUSE DEFINITIVELY ESTABLISHED UPON FURTHER INVESTIGATION, A RESOLUTION PLAN AIMED AT ADDRESSING ENHANCED LOADING TECHNIQUES AND AN IMPROVED IN-PROCESS INSPECTION THAT BETTER REPRESENTS HOW A DEVICE IS LOADED AND DEPLOYED DURING CLINICAL USE ARE BEING IMPLEMENTED.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    ON (B)(6) 2020, A 25MM AMPLATZER CRIBRIFORM OCCLUDER (LOT#7262218) WAS SELECTED FOR IMPLANT. THE DEVICE WAS PREPARED IN THE NORMAL PROCEDURE. ONCE INSIDE THE PATIENT, DISTORTION WAS SEEN ON THE DISC WHEN OPENED ON THE LEFT ATRIUM SIDE. THE SAME DEFORMITY WAS SEEN ON THE DISC WHEN OPENED ON THE RIGHT ATRIUM SIDE. ANOTHER 25MM AMPLATZER CRIBRIFORM OCCLUDER (LOT#7253343) WAS SELECTED FOR IMPLANT, BUT THE SAME DEFORMATION WAS SEEN DURING PREPARATION. THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. A 25MM AMPLATZER PFO OCCLUDER WAS THEN SELECTED FOR IMPLANT AND THE PROCESS WAS COMPLETED SUCCESSFULLY. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354453 AMPLATZER CRIBRIFORM OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-MF-025 7262218 00811806010298

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention