BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 6832222 · Received August 30, 2017

    Report

    Report Number
    2135147-2017-00101
    Event Type
    Injury
    Date Received
    August 30, 2017
    Date of Event
    August 10, 2017
    Report Date
    August 30, 2017
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH ABBOTT SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE PATIENT HAD A MULTI-FENESTRATED ATRIAL SEPTAL DEFECT (ASD) THAT WAS 5.8 MM AND SECOND THAT WAS 26 MM LOCATED ABOUT 6 MM FROM THE SMALLER DEFECT. ON (B)(6) 2017, AN 8 MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS DEPLOYED FIRST ON THE AORTIC SIDE AND THEN A 27 MM FIGULLA FLEX II: FSO (JAPAN LIFELINE) WAS DEPLOYED OVERLAPPING THE ASO. ON (B)(6), A FOLLOW UP ECHOCARDIOGRAM SHOWED ATRIAL FIBRILLATION AND PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA. THE PATIENT WAS ASYMPTOMATIC. THE FSO HAD EMBOLIZED BETWEEN THE LEFT ATRIA AND VENTRICLE. LATER THAT DAY THE FSO AND ASO WERE BOTH SURGICALLY REMOVED. THE MULTI-FENESTRATED ASD WAS CLOSED WITH A PERICARDIAL PATCH AND A MITRAL VALVULOPLASTY WAS PERFORMED. DURING THE PROCEDURE NO ANOMALIES WERE FOUND ON THE ASO. THE PHYSICIAN ALLEGED THE CAUSE OF THE EVENT WAS DUE AN UNDERSIZED FSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611623 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-008

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR