BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER PFO OCCLUDER

    MDR report key: 9226000 · Received October 23, 2019

    Report

    Report Number
    2135147-2019-00323
    Event Type
    Injury
    Date Received
    October 23, 2019
    Date of Event
    September 26, 2019
    Report Date
    December 30, 2019
    Manufacturer
    ST. JUDE MEDICAL CATD
    Product Code
    MLV
    PMA / PMN Number
    P120021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A 30MM AMPLATZER PFO OCCLUDER (PFO) WAS SELECTED FOR IMPLANT, HOWEVER THE DEVICE WAS DEFORMED. A SECOND 30MM AMPLATZER PFO WAS THEN SELECTED FOR IMPLANT, BUT AGAIN WAS DEFORMED. BOTH DEVICES WERE IN CONTACT WITH THE PATIENT. A 25MM AMPLATZER PFO (LOT #: 7029183) WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A 30MM AMPLATZER PFO OCCLUDER (PFO) WAS SELECTED FOR IMPLANT, HOWEVER THE DEVICE WAS DEFORMED. A SECOND 30MM AMPLATZER PFO WAS THEN SELECTED FOR IMPLANT, BUT AGAIN WAS DEFORMED. BOTH DEVICES WERE IN CONTACT WITH THE PATIENT. A 25MM AMPLATZER PFO (LOT #: 7029183) WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019523 AMPLATZER PFO OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ST. JUDE MEDICAL CATD 9-PFO-030 5658363

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention