BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER DUCT OCCLUDER

    MDR report key: 1183563 · Received October 3, 2008

    Report

    Report Number
    2135147-2008-00087
    Event Type
    Injury
    Date Received
    October 3, 2008
    Date of Event
    September 5, 2008
    Report Date
    October 20, 2008
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MAE
    PMA / PMN Number
    P020024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MEDICAL RECORDS AND IMAGES BY AGA'S MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: THIS PATIENT HAD A LARGE PDA WITH A MILD TAPER TOWARD THE PULMONARY ARTERY SIDE. THE DUCTUS MEASURED ABOUT 7MM IN LENGTH AND THE PULMONARY END MEASURED ABOUT 3MM IN DIAMETER. A 6-4 AMPLATZER DUCT OCCLUDER WAS DEPLOYED SUCCESSFULLY, HOWEVER, EMBOLIZED TO THE PA. THE PATIENT WAS REFERRED TO SURGERY FOR DEVICE REMOVAL AND SURGICAL LIGATION OF THE PDA.THE CAUSE OF THE EMBOLIZATION IN THIS PATIENT WAS BECAUSE OF THE LARGE PDA WITH SIGNIFICANT LEFT TO RIGHT FLOW. THE MUSHROOM PORTION OF THE PDA DEVICE WAS IN THE PDA AND WAS THE ONLY PART OF THE DEVICE THAT WAS KEEPING THE DEVICE IN PLACE. POST-DEPLOYMENT ANGIOGRAMS REVEALED SIGNIFICANT FLOW THROUGH AND AROUND THE DEVICE. THE ONLY SIGNIFICANT FINDING WAS THE COMPLETELY NORMAL PROFILE OF THE DEVICE WITHOUT ANY EVIDENCE OF CONSTRICTION; THIS USUALLY SUGGESTS THE DEVICE IS UNDERSIZED. THE ECHO DIAMETER OF THE PDA MEASURED AFTER THE DEVICE EMBOLIZED SHOULD BE COMPARED TO THE ECHO DIAMETER OF THE PDA BEFORE THE CATHETERIZATION WAS PERFORMED. IF LARGER THAN THE PRE-PROCEDURE ECHO, AGA'S MEDICAL CONSULTANT BELIEVES THAT THE DEVICE EMBOLIZED BECAUSE OF UNDERSIZING OF THE DEVICE AND A DUCTAL SPASM. DUCTAL SPASMS HAVE BEEN DESCRIBED BEFORE, AND CAN LEAD TO UNDERESTIMATION OF THE PDA SIZE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE AMPLATZER DUCT OCCLUDER, THE DEVICE WAS RETURNED IN THE ORIGINAL CONFIGURATION. FOLLOWING DECONTAMINATION, THE DEVICE WAS MEASURED AND THE SIZE WAS CONFIRMED TO MEET DIMENSIONAL SPECIFICATIONS. THE DEVICE WAS EXAMINED MICROSCOPICALLY AND NO DEFECTS WERE OBSERVED. 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

    THE DEFECT MEASURED 6MM AT THE AORTIC AMPULLA, 3MM MINOR DIAMETER AND A LENGTH OF 7MM. A 6-4 AMPLATZER DUCT OCCLUDER WAS SELECTED AND IMPLANTED WITHOUT ENCOUNTERING ANY RESISTANCE, ALTHOUGH THE DUCTUS WAS VERY COMPLIANT. THERE WAS A MODERATE RESIDUAL SHUNT AT THE FINAL ANGIOGRAPHY, BUT WAS CONSIDERED TO BE CENTRAL, AND PROBABLY WOULD DIMINISH WITH TIME. THERE WAS NOT A PULMONARY OR AORTIC GRADIENT DURING THE PULL-BACK MEASUREMENTS. THE PATIENT WAS CLOSELY FOLLOWED, DUE TO CONCERNS ABOUT THE COMPLIANT DUCTUS; HOWEVER, THE PATIENT WAS FINE WITH A CLINICALLY DIMINISHING MURMUR. THE FOLLOWING MORNING, THE PATIENT HAD A CONTINUOUS MURMUR AND ECHO REVEALED A 9MM DUCTUS. THE DEVICE HAD MIGRATED TO THE RIGHT PULMONARY ARTERY. THE PATIENT WAS DIRECTED TO SURGERY, WITH AN UNEVENTFUL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER DUCT OCCLUDER CARDIAC OCCLUSION DEVICE MAE AGA MEDICAL CORPORATION 9-PDA-004 M08F16-26

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Required Intervention