BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER PFO OCCLUDER

    MDR report key: 9376942 · Received November 26, 2019

    Report

    Report Number
    2135147-2019-00369
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    November 5, 2019
    Report Date
    March 9, 2020
    Manufacturer
    ST. JUDE MEDICAL CATD
    Product Code
    MLV
    PMA / PMN Number
    P120021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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, ROUND 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 DEFORMATION UPON INITIAL DEPLOYMENT HAS BEEN INVESTIGATED AND A RESOLUTION PLAN AIMED AT ADDRESSING ENHANCED LOADING TECHNIQUES AS WELL AS IMPROVED IN-PROCESS INSPECTION THAT BETTER REPRESENTS HOW A DEVICE IS LOADED AND DEPLOYED DURING CLINICAL USE ARE BEING IMPLEMENTED.

    Description of Event or Problem · 1

    DURING A PFO PROCEDURE, A 25MM DEVICE WAS FIRST CONSIDER FOR CLOSE THE PFO. HOWEVER, IT IS TOO SMALL. THEREFORE, A 30MM DEVICE (9-PFO-030, LOT 6117995) WAS CHOSEN FOR THE PATIENT, PHYSICIAN RETRACTING THE DELIVERY SHEATH TO DEPLOY THE LA DISC, THE LA DISC IS NOT ABLE TO FORM A DISC SHAPE. PHYSICIAN TRIED SEVERAL TIME FOR THE DEPLOYMENT, BUT THE LA DISC JUST NOT LOOK LIKE A DISC SHAPE. AT THE END, ANOTHER 30MM DEVICE (9-FPO-030, LOT 6665698) WAS USED TO COMPLETE THE CASE.

    Description of Event or Problem · 1

    DURING A PFO PROCEDURE, A 25MM DEVICE (LOT 6665698) WAS FIRST CONSIDER FOR CLOSE THE PFO. HOWEVER, IT IS TOO SMALL. THEREFORE, A 30MM DEVICE (9-PFO-030, LOT 6117995) WAS CHOSEN FOR THE PATIENT, PHYSICIAN RETRACTING THE DELIVERY SHEATH TO DEPLOY THE LA DISC, THE LA DISC IS NOT ABLE TO FORM A DISC SHAPE. PHYSICIAN TRIED SEVERAL TIME FOR THE DEPLOYMENT, BUT THE LA DISC JUST NOT LOOK LIKE A DISC SHAPE. AT THE END, ANOTHER 30MM DEVICE (9-FPO-030, LOT 6234047) WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173345 AMPLATZER PFO OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ST. JUDE MEDICAL CATD 9-PFO-030 6117995

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention