BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1342138 · Received March 13, 2009

    Report

    Report Number
    2135147-2009-00024
    Event Type
    Injury
    Date Received
    March 13, 2009
    Date of Event
    February 10, 2009
    Report Date
    May 4, 2009
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMPLATZER SEPTAL OCCLUDER WAS RECEIVED AT AGA MEDICAL IN ITS ORIGINAL CONFIGURATION. THE DEVICE WAS DECONTAMINATED, MEASURED, AND CONFIRMED TO MEET DIMENSIONAL SPECIFICATIONS. THE DEVICE WAS EXAMINED MICROSCOPICALLY AND NO DEFECTS WERE OBSERVED. REVIEW OF THE MEDICAL RECORDS AND IMAGES BY AGA'S MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: THIS PATIENT HAD A LARGE ASD WITH A THIN AND DEFICIENT IVC RIM THAT MADE THE DEFECT OVAL SHAPED. THE DEFECT MEASURED ABOUT 34MM IN FOUR-CHAMBER VIEW AND 32MM IN A MODIFIED SHORT-AXIS VIEW. DUE TO THE LARGE, OVAL SHAPE OF THE DEFECT MADE IT DIFFICULT TO OBTAIN AN ACCURATE BALLOON SIZE.. A 32MM ASO WAS DEPLOYED AND APPEARED IMPROPERLY POSITIONED. THE 32MM ASO WAS EXCHANGED FOR A 34MM. THE 34MM ASO SEATED WELL AND THE DISCS SANDWICHED THE AV RIM, AORTIC RIM, SUPERIOR RIM, PART OF THE POSTERIOR RIM AND THE SVC RIM. REVIEW OF THE IVC RIM WAS NOT INTERROGATED AND/OR NOT RECORDED DURING DEVICE PLACEMENT, ALTHOUGH, IMAGES OBTAINED PRIOR TO DEVICE PLACEMENT SHOWED A SIGNIFICANT DIMINISHED IVC RIM, WHICH WAS ALSO CONFIRMED IN THE OPERATING ROOM. IVC RIM DEFICIENCY TYPICALLY RESULTS IN DEVICE EMBOLIZATION TO THE RIGHT SIDE; COUGHING WILL RESULT IN EMBOLIZATION TO THE LEFT SIDE OF THE HEART. ACCORDING TO AGA'S MEDICAL CONSULTANT, THE PRIMARY CAUSE OF THIS PATIENT'S EMBOLIZATION WAS DUE TO IVC RIM DEFICIENCY. THE SECONDARY CAUSE WAS DUE TO IMPROPER DEVICE SIZING. BALLOON SIZING IN THESE CASES ARE DIFFICULT AS THE EFFECTIVE STOP-FLOW IS HARD TO ACHIEVE BECAUSE OF THE LARGE BALLOON SIZE. AS A RESULT, A RELATIVELY SMALLER DEVICE WAS USED FOR CLOSURE AND ULTIMATELY EMBOLIZED.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE SINCE THE IMPLANT ECHOCARDIOGRAMS OR MEDICAL RECORDS WERE NOT PROVIDED TO AGA MEDICAL FOR REVIEW. ECHOCARDIOGRAMS ARE NEEDED TO CONFIRM SIZING AND EVALUATE OTHER PARAMETERS OF THE IMPLANT PROCEDURE.

    Description of Event or Problem · 1

    A 32MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS PLACED IN A SECUNDUM ATRIAL SEPTAL DEFECT (ASD) THAT MEASURED 30MM BY STOP-FLOW BALLOON SIZING WITH A 10MM POSTERIOR-INFERIOR RIM. A SIGNIFICANT SHUNT WAS PRESENT AT THE POSTERIOR-INFERIOR RIM, SO THE 32MM ASO WAS ELECTIVELY REMOVED TO PLACE A 34MM ASO. THE 34MM ASO WAS PLACED WITHOUT DIFFICULTY AND ASSUMED PROPER POSITION AND CONFIGURATION WITHOUT A SIGNIFICANT SHUNT AND ADEQUATE RIM TISSUE BETWEEN THE DISCS ALL AROUND. THE DEVICE WAS STABLE BEFORE AND AFTER RELEASE. IN THE LAB, THE PATIENT HAD COUGHED WHEN EXTUBATED AND AN ECTOPIC HEARTBEAT WAS NOTED. THE DEVICE WAS FOUND EMBOLIZED IN THE RIGHT VENTRICLE. AN ATTEMPT WAS MADE TO SNARE THE DEVICE; HOWEVER IT WAS ENTANGLED IN THE TRICUSPID VALVE APPARATUS AND COULD NOT BE REMOVED. THE PATIENT WAS SENT TO THE OPERATING ROOM WITH THE SNARE CONTROLLING THE DEVICE. THE ASD WAS SUCCESSFULLY CLOSED SURGICALLY, AND THE INFERIOR RIM WAS FOUND TO BE VERY THIN AND FLOPPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-034 M08F19-04

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention