BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER PFO OCCLUDER

    MDR report key: 10338143 · Received July 29, 2020

    Report

    Report Number
    2135147-2020-00345
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    May 29, 2020
    Report Date
    August 28, 2020
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF DEVICE DEFORMATION COULD NOT BE CONFIRMED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. 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.

    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 30MM AMPLATZER PFO OCCLUDER (7221961) WAS SELECTED FOR IMPLANT. WHILE DEPLOYING THE OCCLUDER A BULBUS DEFORMATION WAS NOTED. THE OCCLUDER WAS REMOVED AND REPLACED WITH ANOTHER 30MM AMPLATZER PFO OCCLUDER (7224657). DURING DEPLOYMENT A BULBUS DEFORMATION WAS NOTED. THE SECOND OCCLUDER WAS REMOVED AND REPLACED WITH A 25MM AMPLATZER CRIBRIFORM OCCLUDER WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. MANUFACTURER REPORT NUMBER: 2135147-2020-00346.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805877 AMPLATZER PFO OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-PFO-030 7224657

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 9-PFO-030, 7221961