BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 3190459 · Received June 26, 2013

    Report

    Report Number
    2135147-2013-00053
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 24 MM ASO WAS RECEIVED IN THE PRODUCT SURVEILLANCE LAB IN SOLUTION AND DECONTAMINATED. THE ASO WAS GROSSLY AND MICROSCOPICALLY EXAMINED, AND BOTH PROXIMAL AND DISTAL DISCS AND THE WAIST WERE MOSTLY COVERED IN WHITE, DENSE TISSUE. THERE WERE SEVERAL PIECES OF BROWN, DENSE TISSUE MIXED IN WITH THE WHITE TISSUE AND LARGER PIECES OF WHITE, DENSE TISSUE ON ONE-HALF OF THE WAIST. THE ASO MET DIMENSIONAL SPECIFICATIONS WHEN MEASURED WITH A CALIBRATED CALIPER. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REVIEWED BY THE ST. JUDE MEDICAL EROSION BOARD WHO CONFIRMED THAT EROSION OCCURRED.

    Description of Event or Problem · 1

    A 24MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS SUCCESSFULLY IMPLANTED IN THE PATIENT'S 22MM ATRIAL SEPTAL DEFECT. THE DEFECT WAS BALLOON-SIZED TO 22MM BY INTRACARDIAC ECHO (ICE) AND 21MM BY FLUOROSCOPY. SATISFACTORY POSITIONING SEATING WAS ASSESSED BY ICE AND NO SIGNIFICANT RESIDUAL LEFT-TO-RIGHT SHUNTING WAS OBSERVED SO THE ASO WAS RELEASED FROM THE DELIVERY CABLE. DEVICE POSITIONING WAS AGAIN CHECKED BY ICE AND FLUOROSCOPY/CINE; TRIVIAL RESIDUAL SHUNTING WAS CONFIRMED BY A RIGHT ATRIAL ANGIOGRAM. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. FOLLOWING A REPEAT TRANS-ESOPHAGEAL ECHO (TEE) SIX MONTHS POST-IMPLANT, NO RESIDUAL SHUNTING WAS OBSERVED. APPROXIMATELY FIVE YEARS POST-IMPLANT, THE PATIENT AWOKE WITH CHEST PAIN. IN THE EMERGENCY ROOM, THE PATIENT WAS DIAGNOSED WITH A PERICARDIAL EFFUSION THAT EVOLVED INTO CARDIAC TAMPONADE. ACCORDING TO A REPEAT TEE, IT WAS SUSPECTED THAT THE ASO HAD ERODED AT THE JUNCTION OF THE RIGHT ATRIUM AND LEFT ATRIAL ROOF. THE PATIENT UNDERWENT SURGERY TO EXPLANT THE ASO AND REPAIR BOTH ATRIAL PERFORATIONS AND THE ATRIAL SEPTAL DEFECT. THE ATRIAL SEPTUM WAS CLOSED USING A HEMASHIELD PATCH BECAUSE OF THE DEFECT CREATED BY EXCISION OF THE ASO; THE RIGHT ATRIAL ROOF WAS THEN CLOSED PRIMARILY WITHOUT DIFFICULTY. THE PATIENT WAS DISCHARGED FIVE DAYS LATER IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290893 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-024 M08A31-05

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention