BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1003916 · Received February 29, 2008

    Report

    Report Number
    2135147-2007-00041
    Event Type
    Injury
    Date Received
    February 29, 2008
    Date of Event
    June 1, 2007
    Report Date
    May 25, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS IMPLANTED IN 2007, AND AN EXAMINATION TWO MONTHS LATER, CONFIRMED THAT ALL WAS WELL. THE PATIENT PRESENTED THE NEXT MONTH REPORTING CHEST PAIN AND DYSPNEA, AND TOMODENSITOMETRY EXAMINATION REVEALED A HEMOPERICARDIUM. THE TOMODENSITOMETRY REPORT REVEALED ABSENCE OF MIGRATION OF THE ASD, AND AN ABSENCE OF HEMOMEDIASTINUM OR AN ACTIVE LEAK OF CONTRAST MEDIUM. THE REPORT SUGGESTS PROBABLY INTRAPERITONEAL EFFUSION. THE PHYSICIAN PERFORMED A PERICARDIAL PUNCTURE, AND THERE WAS NO RECURRENCE AFTER TEN DAYS. SURGERY WAS PERFORMED ELEVEN DAYS LATER, AND THE DEVICE WAS REMOVED AND THE DEFECT WAS PATCHED. THE SURGICAL REPORT DID NOT IDENTIFY THE LOCATION OF THE VESSEL INJURY. THE IMPLANT ECHOCARDIOGRAM WAS FORWARDED TO AGA?S MEDICAL CONSULTANT FOR REVIEW. THE MEDICAL CONSULTANT OBSERVED THAT THE LEFT DISK PROTRUDED INTO THE AORTA, AND THE DEVICE SHAPE WAS ALTERED IN CARDIAC SYSTOLE. THIS SUGGESTS THAT THE DISK WAS WEDGED IN THE SEPTUM. WHEN THE DEVICE DEFORMED DURING THE CARDIAC CYCLE, IT MAY HAVE TENTED THE ATRIAL ROOF. THE DEVICE SIZING APPEARED TO BE ADEQUATE. THIS EVENT HAS NOT BEEN REVIEWED BY AGA MEDICAL?S EROSION BOARD. WHEN THIS REVIEW IS COMPLETED, AGA MEDICAL WILL SUBMIT A SUPPLEMENTAL MDR.

    Additional Manufacturer Narrative · 1

    A CD WAS PROVIDED AND ONLY CONTAINS SEQUENCE TO THE ABRASION EXAM. REPORTS ARE BEING SENT FOR TRANSLATION AND MEDICAL REVIEW. THE RESULTS OF THIS INVESTIGATION INDICATED THAT THE DEVICE SELECTION WAS ADEQUATE; HOWEVER, THE LOCATION OF THE DEVICE OBSERVED ON ECHOCARDIOGRAM SUGGESTED THE DEVICE WAS WEDGED IN THE AORTA RESULTING IN THE HEMOPERICARDIUM. THE HEMOPERICARDIUM THREE MONTHS POST-IMPLANT WAS NOT A RESULT OF A MANUFACTURE OF THE DEVICE AS EVIDENCED BY THE ANALYSIS PERFORMED.

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REVIEWED BY AGA MEDICAL EROSION BOARD CHAIRS ON (B)(6) 2011 AND DEFINITE EROSION WAS CONFIRMED.

    Description of Event or Problem · 1

    THE IMPLANT PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA AND TEE. AN ATRIAL SEPTAL DEFECT OSTIUM SECUNDUM TYPE WAS EVALUATED AT 11MM BY TEE PRIOR TO THE PROCEDURE. A 20MM SIZING BALLOON (BOSTON SCIENTIFIC EQUALISER) WAS UTILIZED. THE DEFECT WAS SIZED AT 14MM BY BALLOON AND 13X15MM BY ECHO. A 16MM ASD DEVICE WAS IMPLANTED. NO PROBLEMS OCCURRED DURING PLACEMENT AND THE OCCLUDER WAS VERY STABLE BEFORE RELEASE. NO RESIDUAL SHUT WAS OBSERVED AFTER RELEASE. THREE MONTHS POST IMPLANT, HEMOPERICARDIUM WAS OBSERVED BY EXAMINATION. THE DEVICE WAS SURGICALLY REMOVED SEVERAL DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-016 M06J05-41

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention