BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER® SEPTAL OCCLUDER

    MDR report key: 1722339 · Received June 14, 2010

    Report

    Report Number
    2135147-2010-00098
    Event Type
    Injury
    Date Received
    June 14, 2010
    Date of Event
    May 25, 2010
    Report Date
    August 20, 2010
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGING REVIEW: REVIEW OF ONE CD WITH THREE ECHOCARDIOGRAMS (TWO INTRA-PROCEDURE TRANSESOPHAGEAL ECHOCARDIOGRAMS (TEE) AND ONE TRANSTHORACIC ECHOCARDIOGRAM (TTE)), BY AGAS MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: THE TEE SHOWED A LARGE SECUNDUM ATRIAL SEPTAL DEFECT (ASD). THE PATIENT HAD ADEQUATE AV VALVE AND POSTERIOR RIMS. THE AORTIC RIM WAS ABSENT IN SOME VIEWS. THE SVC RIM WAS ADEQUATE. THE IVC RIM WAS NEVER DOCUMENTED. THE CORONARY SINUS RIM WAS COMPLETELY ABSENT. THE ASD WAS BALLOON SIZED. THE STATIC DIAMETER OF THE ASD WAS LARGEST IN THE SHORT AXIS VIEW AT 56-DEGREES (34MM). BALLOON SIZING YIELDED THE DIAMETER OF 34MM. IT APPEARED THAT A 34MM ASO WAS IMPLANTED OR AS STATED ABOVE UPSIZED TO 38 MM. THE DEPLOYMENT WAS SUCCESSFUL WITH GOOD STRADDLING OF THE AORTIC RIM, GOOD CAPTURE OF THE POSTERIOR, SUPERIOR AND SVC RIMS. THE ASO HUNG ON TO THE MITRAL VALVE AND MILD REGURGITATION WAS OBSERVED. THE TTE SHOWED THE ASO HAD EMBOLIZED INTO THE RIGHT VENTRICLE. ANALYSIS RESULTS: AGA MEDICAL COULD NOT EVALUATE THE DEVICES INVOLVED IN THIS INCIDENT SINCE THEY WERE NOT RETURNED TO US. CONCLUSION: ACCORDING TO AGAS MEDICAL CONSULTANT THE FOLLOWING CONCLUSIONS WERE DRAWN: THIS WAS A LARGE DEFECT WITH MORE THAN ONE RIM DEFICIENCY. HENCE, IT WAS TECHNICALLY DIFFICULT. DEVICE EMBOLIZATION OCCURRED DUE TO AN ABSENT CORONARY SINUS RIM. THE IVC RIM WAS NOT DOCUMENTED AND MAY HAVE BEEN SMALL OR ABSENT AS WELL.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. REGARDING A (B)(6) RESULT GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. A (B)(6) RESULT WAS OBTAINED VIA AN ALTERNATE METHODOLOGY. A SUBSEQUENT SAMPLE DRAWN FROM THE PATIENT A FEW MONTHS LATER RESULTED IN A (B)(6) RESULT. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Description of Event or Problem · 1

    DURING AN IMPLANT PROCEDURE, A 34MM AND 36MM AMPLATZER® SEPTAL OCCLUDER (ASO) WERE RESIZED. A 38MM ASO WAS ATTEMPTED BUT DISLODGED POST-PROCEDURE. SURGICAL REMOVAL OF THE ASO AND REPAIR OF THE DEFECT WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER® SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-038 M09E04-03

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention