BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER CRIBRIFORM OCCLUDER

    MDR report key: 9166269 · Received October 8, 2019

    Report

    Report Number
    2135147-2019-00319
    Event Type
    Injury
    Date Received
    October 8, 2019
    Date of Event
    September 26, 2019
    Report Date
    November 18, 2019
    Manufacturer
    ST. JUDE MEDICAL CATD
    Product Code
    MLV
    UDI-DI
    00811806010298
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF A ROUND, BULBOUS DEPLOYMENT WAS CONFIRMED. FOLLOWING THE SIMULATED DEPLOYMENT, THE 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

    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 CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT. DURING DEPLOYMENT INSIDE THE PATIENT, THE PHYSICIAN OBSERVED A WRONGLY SHAPE OF THE DEVICE, DESCRIBED AS THE RIGHT DISC IN A LOBE FORM, AND IT WAS REMOVED. A SECOND 25MM AMPLATZER CRIBRIFORM OCCLUDER (LOT #: 6983956) FROM THE SAME BATCH/LOT NUMBER WAS SELECTED. HOWEVER, DURING DEVICE PREPARATION OF THE SECOND DEVICE, THE SAME WRONGLY SHAPE OF THE RIGHT DISC IN A LOBE FORM WAS OBSERVED. AN UNKNOWN SIZED AMPLATZER PFO OCCLUDER (LOT #: UNKNOWN) WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A 25MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT. DURING DEPLOYMENT INSIDE THE PATIENT, THE PHYSICIAN OBSERVED A WRONGLY SHAPE OF THE DEVICE, DESCRIBED AS THE RIGHT DISC IN A LOBE FORM, AND IT WAS REMOVED. A SECOND 25MM AMPLATZER CRIBRIFORM OCCLUDER (LOT #: 6983956) FROM THE SAME BATCH/LOT NUMBER WAS SELECTED. HOWEVER, DURING DEVICE PREPARATION OF THE SECOND DEVICE, THE SAME WRONGLY SHAPE OF THE RIGHT DISC IN A LOBE FORM WAS OBSERVED. A 25MM AMPLATZER PFO OCCLUDER (LOT #: 7050634) WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961273 AMPLATZER CRIBRIFORM OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ST. JUDE MEDICAL CATD 9-ASD-MF-025 6983956 00811806010298

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention