BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER PFO OCCLUDER

    MDR report key: 9410319 · Received December 4, 2019

    Report

    Report Number
    2135147-2019-00413
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    November 19, 2019
    Report Date
    January 8, 2020
    Manufacturer
    ST. JUDE MEDICAL CATD
    Product Code
    MLV
    UDI-DI
    00811806011288
    PMA / PMN Number
    P120021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF DEFORMITY UPON DEPLOYMENT WAS CONFIRMED. THE OCCLUDER WAS ABLE TO RE-CONFORM TO ITS PROPER CONFORMATION WITH LIGHT PRESSURE APPLIED TO THE EDGES OF THE DISCS, MEETING 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. THE CAUSE OF THE INITIAL BULBOUS SHAPE COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A 25MM PFO OCCLUDER (REF 9-PFO-025, LOT 7081493) WAS SELECTED TO IMPLANT IN A PATIENT. DURING DEPLOYMENT, THE PHYSICIAN OBSERVED IN ANGIO AND ECHO A WRONG SHAPE OF THE DEVICE: RIGHT DISC WAS IN A LOBE SHAPE, LIKE A SEMI-BALL, IT WAS NOT A DISC. HE DECIDED TO CHANGE TO ANOTHER DEVICE, AND A 25MM PFO OCCLUDER WITH DIFFERENT LOT NUMBER (9-PFO-025, LOT 7120064) WAS SELECTED AND SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A 25MM PFO OCCLUDER (REF 9-PFO-025, LOT 7081493) WAS SELECTED TO IMPLANT IN A PATIENT. DURING DEPLOYMENT, THE PHYSICIAN OBSERVED IN ANGIO AND ECHO A WRONG SHAPE OF THE DEVICE: RIGHT DISC WAS IN A LOBE SHAPE, LIKE A SEMI-BALL, IT WAS NOT A DISC. HE DECIDED TO CHANGE TO ANOTHER DEVICE, AND A 25MM PFO OCCLUDER WITH DIFFERENT LOT NUMBER (9-PFO-025, LOT 7120064) WAS SELECTED AND SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208450 AMPLATZER PFO OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ST. JUDE MEDICAL CATD 9-PFO-025 7081493 00811806011288

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention