BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 10320583 · Received July 24, 2020

    Report

    Report Number
    2135147-2020-00307
    Event Type
    Injury
    Date Received
    July 24, 2020
    Report Date
    July 24, 2020
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED IN A RESEARCH ARTICLE, TAMPONADE WAS SEEN IN 23 PATIENTS BETWEEN 1998 AND 2004. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE ARTICLE "TWO CASES OF PERICARDIAL TAMPONADE DUE TO NITINOL WIRE FRACTURE OF A GORE SEPTAL OCCLUDER" WAS REVIEWED. THIS ARTICLE WAS A META-ANALYSIS OF STUDIES INVOLVING ATRIAL SEPTAL OCCLUDERS. THE ARTICLE MADE REFERENCE TO A SAFETY COMMUNICATION TITLED "FOOD AND DRUG ADMINISTRATION. ST JUDE AMPLATZER ATRIAL SEPTAL OCCLUDER (ASO): SAFETY COMMUNICATION: REPORTS OF TISSUE EROSION" BETWEEN 1998 AND 2004, 23 PATIENTS WITH PERICARDIAL TAMPONADE WERE REPORTED TO AGA MEDICAL (ABBOTT). THE PAPER CONCLUDED THAT A DEFICIENT AORTIC OR SUPERIOR RIM AND USE OF AN ASD DEVICE WHOSE DIAMETER IS 2 MM GREATER THAN THE BALLOON-STRETCHED DIAMETER OF THE ASD INCREASED THE RISK OF DEVICE EROSION. THE PRIMARY AUTHOR IS PREETHAM KUMAR, MD, OF DIVISION OF CARDIOLOGY, DEPARTMENT OF MEDICINE, UNIVERSITY OF CALIFORNIA, LOS ANGELES, LOS ANGELES, CALIFORNIA. THE CORRESPONDING EMAIL IS: [email protected].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788228 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R