BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1190383 · Received October 9, 2008

    Report

    Report Number
    2135147-2008-00089
    Event Type
    Injury
    Date Received
    October 9, 2008
    Date of Event
    July 11, 2008
    Report Date
    February 23, 2009
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MEDICAL RECORDS AND IMAGES BY AGA'S MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: THIS PATIENT UNDERWENT DEVICE CLOSURE OF A COMPLEX, FENESTRATED ASD. SHE HAD A HISTORY OF PULMONARY HYPERTENSION AND WAS ON CALCIUM CHANNEL BLOCKERS. DURING CARDIAC CATHETERIZATION, THE PATIENT'S PULMONARY PRESSURES WERE NORMAL (MEAN 22 MMHG). A LARGE DEFECT WAS SEEN IN THE HIGH SECUNDUM AREA AND A SMALL DEFECT WAS PRESENT IN THE INFERIOR AREA. AFTER INITIAL BALLOON SIZING, A 20MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS DEPLOYED, BUT WAS FOUND TO BE UNSATISFACTORY. IT WAS REMOVED AND REPLACED BY A 24MM ASO. ALTHOUGH THE DEVICE LOOKED ECCENTRIC INITIALLY, IT CONFORMED TO THE SEPTUM AFTER RELEASE. A SMALL SHUNT THAT WAS PRESENT BEFORE THE DEVICE WAS RELEASED REMAINED UNCHANGED AFTER THE ASO WAS RELEASED. THE LOCATION OF THE SHUNT WAS TOWARD THE ATRIOVENTRICULAR (AV) VALVE RIM IN 4-CHAMBER VIEW AND TOWARD THE IVC RIM IN BI-CAVAL VIEW. THE FOLLOWING DAY, A SMALL PERICARDIAL EFFUSION WAS SEEN BY TTE. AT ONE-MONTH FOLLOW-UP, THE EFFUSION PERSISTED, ALTHOUGH IT WAS SLIGHTLY LESS THAN THE ONE-DAY POST IMPLANT TTE. THE PATENT DID NOT EXPERIENCE SEQUELAE EXCEPT FOR THE ONSET OF CHEST PAIN, WHICH RESOLVED. ACCORDING TO AGA'S MEDICAL CONSULTANT, THE ATRIAL SEPTAL RIMS IN THIS PATIENT WERE COMPLEX. THE SEPTUM WAS ANEURYSMAL, WITH BOWING TOWARD THE RIGHT ATRIUM. IN ADDITION, THE SEPTUM WAS FENESTRATED, THIN AND APPEARED FRAGILE. THE AORTIC RIM WAS SMALL AND THE POSTERIOR RIM WAS THIN AND FLIMSY. ON FOLLOW-UP ECHOCARDIOGRAMS, THE DEVICE APPEARED TO BE IN THE RIGHT ATRIAL CAVITY. THE SIZE OF THE DEVICE CHOSEN WAS CORRECT BASED UPON THE SEPTAL ANATOMY. HAD THE DEVICE BEEN OVERSIZED, THE PATIENT MAY HAVE HAD A SIGNIFICANT COMPLICATION. THE ECHOCARDIOGRAMS AFTER THE ASO WAS RELEASED SHOWED THE LEFT DISC EDGE RIDING THE AORTA, WITHOUT IMPINGEMENT OR PRESSURE ON THE AORTIC ROOT. THE PERICARDIAL EFFUSION WAS MOST LIKELY DUE TO AN INFLAMMATORY RESPONSE SINCE THE DEVICE WAS ADJACENT TO THE ATRIAL FREE WALL AND THE AORTA. A BREACH IN THE INTEGRITY OF THE ATRIAL WALL WAS NOT SEEN AND THE SIZE OF THE EFFUSION AFTER ONE MONTH APPEARED TO BE SMALLER, WHICH ARE BOTH POSITIVE FINDINGS.IN THIS CASE, THE PRESENCE OF AN ADJACENT SECOND DEFECT, THE THIN RIM BETWEEN THE TWO DEFECTS, AND THE CORRECT SELECTION OF DEVICE SIZE GAVE THE DEVICE "SPACE" FOR ADJUSTMENT AND RECONFIGURATION. THIS PREVENTED THE DEVICE FROM PUSHING INTO THE AORTA. PATIENTS WITH THIS TYPE OF DEFECT SHOULD BE FOLLOWED CLOSELY, AT LEAST ONCE A MONTH, UNTIL SIX MONTHS.THIS EVENT WAS REVIEWED BY AGA'S ASD EROSION ADJUDICATION BOARD AND THE FOLLOWING OBSERVATIONS WERE REPORTED: THIS PATIENT EXPERIENCED PERICARDITIS AND AN EFFUSION WITHOUT EVIDENCE OF AN EROSION.

    Additional Manufacturer Narrative · 1

    OTHER TEXT : REMAINS IMPLANTED

    Description of Event or Problem · 1

    THE MEDICAL RECORDS REPORTED THE PATIENT PRESENTED WITH CHEST PAIN FOUR (4) DAYS POST-IMPLANT. SUBLINQUAL NITROGLYCERIN RELIEVED THE CHEST PAIN. ECHOCARDIOGRAM SHOWED A VERY, VERY SLIGHT EFFUSION WITH NORMAL VENTRICULAR FUNCTION. THE DEVICE WAS WELL-SEATED WITH NO EXCESSIVE MOVEMENT, AND NO SIGNIFICANT RESIDUAL SHUNTING THROUGH THE DEVICE. THERE CONTINUED TO BE A PRESENCE OF THE SMALL FENESTRATION APPROXIMATELY 1-2MM IN DIAMETER. FOLLOW-UP IN THREE (3) MONTHS WAS RECOMMENDED. NO ADDITIONAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER AMPLATZER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-024 M06F29-28

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other