BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1646492 · Received March 31, 2010

    Report

    Report Number
    2135147-2010-00059
    Event Type
    Injury
    Date Received
    March 31, 2010
    Date of Event
    February 4, 2008
    Report Date
    August 2, 2010
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMPLATZER SEPTAL OCCLUDER WAS RETURNED TO AGA MEDICAL IN ITS 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.NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MEDICAL RECORDS AND IMAGES BY AGA'S MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: THE PROCEDURAL TEE SHOWED A LARGE, DYNAMIC, SECUNDUM ASD. THE PATIENT HAD AN ADEQUATE BUT THIN AV VALVE RIM. THE AORTIC, SVC AND CORONARY SINUS RIMS WERE ADEQUATE. THE POSTERIOR RIM WAS THIN AND THE IVC RIM WAS DEFICIENT AND FLIMSY. THE DEFECT MEASURED 16MM TO 21MM AT 0 AND 45 DEGREES. AT 94 DEGREES, THE DEFECT MEASURED 22MM, AS THE IVC RIM DISAPPEARED DURING ATRIAL DIASTOLE. THE DEFECT WAS BALLOON SIZED TO 27MM, WHICH APPEARED ADEQUATE FOR STOP-FLOW DIAMETER; ALTHOUGH A SMALL SHUNT COULD NOT BE RULED OUT TOWARD THE AORTIC RIM. THE 26MM ASO WAS INITIALLY DEPLOYED BUT THE DISCS WERE NOT PARALLEL TO THE ASD AND THE ASO PROLAPSED IN THE DEFECT. A SUBSEQUENT DEPLOYMENT SHOWED OPTIMAL CAPTURE OF THE AORTIC RIM AND PERHAPS THE POSTERIOR RIM. THE SVC RIM CAPTURE WAS MINIMAL, AND THE IVC AND AV RIMS WERE NOT CAPTURED. THE ASO EMBOLIZED IMMEDIATELY FOLLOWING RELEASE. FOLLOWING THE EMBOLIZATION, THE ASD MEASURED 31MM. ACCORDING TO AGA'S MEDICAL CONSULTANT, THE ASO EMBOLIZED DUE TO THE NON-CAPTURE OF THE DEFICIENT AND DISAPPEARING IVC RIM AND MINIMAL CAPTURE OF THE SVC RIM.

    Description of Event or Problem · 1

    TO SUMMARIZE THIS EVENT, THE 26MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS SURGICALLY REMOVED FOLLOWING SPONTANEOUS EMBOLIZATION IN A PATIENT WITH A LARGE ATRIAL SEPTAL DEFECT (ASD). PERCUTANEOUS RETRIEVAL WAS UNSUCCESSFUL.THIS EVENT IS REPORTABLE TO THE FDA SINCE THE DEVICE EMBOLIZED AND REQUIRED INTERVENTION TO RETRIEVE THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WEDGE RESECTION PROCEDURE, ON THE SECOND FIRING, THE DEVICE ONLY PARTIALLY FIRED AND THE STAPLE LINE WAS INCOMPLETE. THE 'DEFECT' IN THE STAPLE LINE WAS SUTURED WHICH TOOK AN ADDITIONAL FORTY MINUTES TO COMPLETE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-026 M08D08-04

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention