BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1842554 · Received September 23, 2010

    Report

    Report Number
    2135147-2010-00148
    Event Type
    Death
    Date Received
    September 23, 2010
    Date of Event
    August 10, 2010
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGA MEDICAL COULD NOT EVALUATE THE PRODUCT INVOLVED IN THIS EVENT SINCE IT WAS NOT RETURNED TO US. THE DEVICE'S MANUFACTURING RECORDS COULD NOT BE REVIEWED SINCE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, EACH DEVICE IS INSPECTED BY CERTIFIED OPERATORS TO ENSURE EACH DEVICE IS ACCEPTABLE DURING MANUFACTURING AND PRIOR TO SHIPMENT. REVIEW OF THE MEDICAL RECORDS AND IMAGES BY AGA'S MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: FOUR CDS WITH ECHOCARDIOGRAMS (PRE-PROCEDURE TEE, INTRA-PROCEDURE ANGIOGRAMS, THE FOLLOWING DAY TTE AND A TEE PERFORMED TWO DAYS AFTER THE PROCEDURE) AND ANGIOGRAMS WERE PROVIDED FOR REVIEW. THE PROCEDURE WAS PERFORMED UNDER INTRACARDIAC ECHOCARDIOGRAM (ICE) GUIDANCE BUT THE IMAGES WERE NOT PROVIDED. THE PRE-PROCEDURE TEE REVEALED A LARGE ATRIAL SEPTAL DEFECT THAT WAS ANTERIORLY AND SUPERIORLY LOCATED AS EVIDENCED BY NEARLY INTACT ATRIAL SEPTUM IN THE 4-CHAMBER VIEW. THE ASD BECAME VISIBLE AS THE AORTA CAME INTO VIEW. THE AORTIC RIM WAS ABSENT IN THE MODIFIED 4-CHAMBER VIEW AND THE POSTERIOR RIM WAS THIN AND FLAILING. THE DEFECT MEASURED ABOUT 20MM IN THIS VIEW. THE TRANSVERSE SINUS WAS SEEN IN THE 4-CHAMBER VIEW AND SOME SEPARATION WAS NOTED BETWEEN THE ATRIAL FREE WALL AND THE AORTA. THE DEFECT IN THE MODIFIED 4-CHAMBER VIEW WAS DYNAMIC IN NATURE. IN THE BI-CAVAL VIEW THE DEFECT WAS ABOUT 22MM AND HAD GOOD SUPERIOR VENA CAVA (SVC) AND INFERIOR VENA CAVA (IVC) RIMS. THE SEPTUM IN THE MODIFIED 4-CHAMBER VIEW WAS SLIGHTLY MAL-ALIGNED AS WELL. THE DEFECT WAS MOST HYPER-DYNAMIC IN THE SHORT-AXIS AORTIC VIEW WHERE IT ALMOST DISAPPEARED DURING ATRIAL SYSTOLE. THE SECOND CD WAS OF THE BALLOON SIZING IN THE CATH LAB. A NUMED BALLOON WAS USED TO SIZE THE DEFECT. AFTER DEVICE DEPLOYMENT, THE DEVICE POSITION BY FLUOROSCOPY APPEARED OPTIMAL. THE THIRD CD WAS A TRANSTHORACIC ECHOCARDIOGRAM (TTE) PERFORMED THE DAY FOLLOWING THE CATH PROCEDURE. OF NOTE WAS THE PRESENCE OF A SMALL PERICARDIAL EFFUSION IN THE POSTERIOR ASPECT OF THE HEART. IN SHORT-AXIS VIEW, THE RIGHT ATRIAL DISC SEEMED TO PUSH ON THE AORTA. THIS, HOWEVER, USUALLY IS NOT ALARMING IN NATURE. THE FOURTH CD WAS OF THE TEE THAT WAS PERFORMED TWO DAYS AFTER THE PROCEDURE. THE ECHO REVEALED THAT THE DISCS WERE SOMEWHAT HIGHER IN THE 4-CHAMBER VIEW SUGGESTING AND ALSO PROVING THAT THE DEFECT WAS HIGH IN LOCATION. THERE WAS A SMALL VOLUME SHUNT SEEN IN THE MODIFIED 4-CHAMBER VIEW. THE EDGES OF BOTH DISCS WERE FACING AND GENTLY PENETRATING THE AORTA WITH SOME BUCKLING OF THE LEFT ATRIAL DISC IN ATRIAL SYSTOLE, AS THE DEVICE COMPRESSED BETWEEN THE AORTA AND THE POSTERIOR WALL. THE ASO WAS NOT OVER-SIZED BASED UPON THE ASD DIAMETER AND THE CURRENT COMMON PRACTICE BY ALMOST ALL PHYSICIANS. THE BALLOON SIZING WAS PERFORMED USING STOP-FLOW TECHNIQUE, AS EVIDENCED BY FLUOROSCOPY. UNFORTUNATELY, THE ICE IMAGES WERE NOT RECORDED AND HENCE NOT AVAILABLE FOR REVIEW. ACCORDING TO AGA'S MEDICAL CONSULTANT, THE CAUSES OF THE DEVICE PERFORATION IN THIS PATIENT WERE MULTI-FACTORIAL AND INCLUDE THE FOLLOWING: ABSENT AORTIC RIM IN MULTIPLE VIEWS. BALD AORTA IN THE MODIFIED 4-CHAMBER VIEW. HYPER-DYNAMIC DEFECT IN MULTIPLE VIEWS. THIN POSTERIOR RIM WITH A TENDENCY TO GIVE IN. SOMEWHAT ECCENTRIC DEFECT THAT MAKES THE PHYSICIAN MORE PRONE TO PULL THE DEVICE IN. PLEASE NOTE THAT THE ATRIAL PERFORATION, ALBEIT SMALL, OCCURRED SIGNIFICANTLY PRIOR TO THE PATIENT'S TAMPONADE. THIS WAS EVIDENCED BY OLD BLOOD IN THE PERICARDIAL CAVITY. ACCORDING TO THE AUTOPSY FINDINGS THE PERFORATION WAS CAUSED BY THE LEFT ATRIAL DISC. THE LEFT ATRIAL DISC WAS VISIBLE OUTSIDE OF THE ATRIAL WALL. THERE WAS RECIPROCAL INJURY SEEN ON THE OUTSIDE OF THE AORTIC WALL AND EXCORIATION WAS VISIBLE INSIDE THE AORTIC WALL.

    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

    ACCORDING TO THE INFORMATION RECEIVED, A FEMALE PATIENT IN HER (B)(6) WAS IMPLANTED ON (B)(6) 2009 WITH A 22MM AMPLATZER SEPTAL OCCLUDER (ASO) WITH A PARTIALLY DEFICIENT ANTERIOR RIM. THE ASO WAS ACTUALLY UNDERSIZED WITH A SMALL RESIDUAL DEFECT ON TEE THE NEXT DAY. IN (B)(6) 2010, THE PATIENT WAS PLAYING CARDS AND HAD A SYNCOPAL EPISODE AND SUDDEN CARDIAC DEATH. AUTOPSY DEMONSTRATED A SMALL ATRIAL PERFORATION NEXT TO THE POSTERIOR AORTIC CUSP WITH A SMALL LACERATION OF THE AORTA OPPOSITE OF THE ASO. THERE WAS A PERICARDIAL EFFUSION WITH BLOOD OF VARIOUS AGES IN THE PERICARDIUM. THE PATIENT WAS ASYMPTOMATIC BEFORE THIS EVENT. THE MEDICAL RECORDS AND IMAGING HAVE BEEN RECEIVED FOR THIS EVENT AND ARE CURRENTLY BEING REVIEWED BY AGA'S MEDICAL CONSULTANT. ONCE THIS REVIEW IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-022

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death