BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER CRIBRIFORM OCCLUDER

    MDR report key: 3761346 · Received April 21, 2014

    Report

    Report Number
    2135147-2014-00034
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 7, 2014
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039/S013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    SJM COULD NOT EVALUATE THE ACO INVOLVED IN THIS INCIDENT SINCE IT WAS NOT RETURNED TO US. THE DEVICE'S MANUFACTURING RECORDS COULD NOT BE REVIEWED SINCE THE LOT NUMBER FOR THE AFFECTED PRODUCT WAS NOT PROVIDED TO ST. JUDE MEDICAL. HOWEVER, EACH DEVICE IS INSPECTED BY CERTIFIED OPERATORS TO ENSURE EACH DEVICE IS ACCEPTABLE DURING MANUFACTURING AND PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    A 35MM AMPLATZER CRIBRIFORM OCCLUDER (ACO) WAS USED TO CLOSE A PATENT FORAMEN OVALE (PFO) FOR A PATIENT WITH PLATYPNEA ORTHODEOXIA DISORDER. AT SOME POINT POST PROCEDURE THE ACO SHIFTED ALLOWING THE PFO TO OPEN, RESULTING IN DESATURATION AND A PERSISTENT RIGHT TO LEFT SHUNT. THE PATIENT RETURNED TO THE CATH LAB WHERE PERCUTANEOUS RETRIEVAL WAS ATTEMPTED BUT THE SNARED ACO EMBOLIZED. THE PATIENT WAS SENT TO SURGERY TO HAVE THE ACO REMOVED AND THE DEFECT CLOSED WITH A PATCH.

    Description of Event or Problem · 1

    A 35MM AMPLATZER CRIBRIFORM OCCLUDER (ACO) WAS USED TO CLOSE A COMPLEX ATRIAL SEPTAL DEFECT FOR A PATIENT WITH PLATYPNEA ORTHODEOXIA DISORDER. THE PATIENT STILL HAD DESATURATION ISSUES AFTER DEVICE PLACEMENT. ECHO SHOWED THE ACO TO BE IN GOOD POSITION, BUT A RESIDUAL SHUNT REMAINED. THE PATIENT WAS SENT TO SURGERY TWO DAYS AFTER IMPLANT TO HAVE THE ACO REMOVED AND THE DEFECT CLOSED WITH A PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239950 AMPLATZER CRIBRIFORM OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-MF-035

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention SNARE