BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER CRIBRIFORM OCCLUDER

    MDR report key: 9252729 · Received October 29, 2019

    Report

    Report Number
    2135147-2019-00357
    Event Type
    Injury
    Date Received
    October 29, 2019
    Date of Event
    October 16, 2019
    Report Date
    December 23, 2019
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    00811806010304
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF A DEFORMED DEPLOYMENT WAS CONFIRMED. FOLLOWING THE SIMULATED DEPLOYMENT, THE DEFORMED, 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, THE ROOT CAUSE OF THE DEFORMATION UPON INITIAL DEPLOYMENT IS UNDER FURTHER INVESTIGATION.

    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) 2019, A 25MM AMPLATZER PFO OCCLUDER (LOT NUMBER: 6980592) WAS MIS-SIZED, TOO SMALL AND EXCHANGED FOR A 30MM AMPLATZER CRIBRIFORM OCCLUDER. DURING IMPLANT, THE LEFT DISC WAS REPORTED TO HAVE NOT "FLATTENED" AS EXPECTED AND WAS EXCHANGED FOR ANOTHER 30MM AMPLATZER CRIBRIFORM OCCLUDER (LOT NUMBER: 7102848). THE SAME ISSUE OCCURRED AND THE USER SUSPECTS THE EVENT IS DUE TO THE ANATOMY OF THE PFO. THE DEVICE WAS REMOVED AND A 35MM AMPLATZER PFO OCCLUDER (LOT NUMBER: UNKNOWN) WAS SUCCESSFULLY IMPLANTED. OF NOTE, A 24MM AMPLATZER SIZING BALLOON II WAS SELECTED FOR USE DURING THE PROCEDURE AND APPEARED TO BE DAMAGED AND WAS EXCHANGED FOR A SECOND 24MM AMPLATZER SIZING BALLOON II. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046317 AMPLATZER CRIBRIFORM OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-MF-030 6840876 00811806010304

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention