BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1172183 · Received September 25, 2008

    Report

    Report Number
    2135147-2008-00080
    Event Type
    Injury
    Date Received
    September 25, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 20, 2008
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. DURING MANUFACTURING, THIS DEVICE UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION, INCLUDING A TEST SIMULATING LOADING AND DEPLOYMENT. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MEDICAL RECORDS AND IMAGING BY AGA'S MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: THIS PATIENT WAS DIAGNOSED WITH A VERY LARGE ASD. TEE REVEALED A LARGE HIGH SECUNDUM ASD WITH DEFICIENT AORTIC RIM AND A VERY THIN, BUT ADEQUATE IVC RIM. THERE WAS ALSO SUGGESTION OF A RIM DEFICIENCY TOWARDS THE CORONARY SINUS, BUT THE ACQUIRED IMAGES WERE FOR A VERY SHORT LENGTH. THE DEFECT MEASURED 30-33MM BY MEASUREMENTS OBTAINED. IN SOME AREAS, HOWEVER, THE DEFECT WAS ALMOST 39MM+, ESPECIALLY IF THE THIN RIM OF THE IVC WAS INCLUDED. ALTHOUGH BALLOON SIZING WAS NOT PERFORMED, IT MAY NOT HAVE YIELDED ANY PERTINENT INFORMATION. THE INITIAL DEPLOYMENT REVEALED AN UNSTABLE POSITION OF THE DEVICE. MULTIPLE ATTEMPTS WERE MADE TO DEPLOY THE DEVICE AND THE FINAL RESULT LOOKED OPTIMAL. THE DEVICE LATER EMBOLIZED AND WAS RETRIEVED SUCCESSFULLY.BASED ON THE IMAGES PROVIDED, THIS WAS A VERY LARGE, HIGH SECUNDUM ASD WITH A DEFICIENT AORTIC RIM AND A THIN IVC RIM. THE DEFECT WOULD HAVE BEEN MORE THAN 38MM IF THE THIN IVC RIM WAS INCLUDED. EXCELLENT DEVICE DEPLOYMENT TECHNIQUE WAS USED AS WELL AS THE CORRECT CHOICE OF DEVICE SIZE. DEVICE EMBOLIZATION, DESPITE EXCELLENT POSITIONING, OCCURRED DUE TO THE THIN IVC RIM THAT WAS INADEQUATE TO HOLD THE DEVICE. RIGHT ATRIAL EMBOLIZATION IS THE HALLMARK OF IVC RIM DEFICIENCY. THE CORONARY SINUS RIM DEFICIENCY MAY HAVE ALSO PLAYED AN ADDITIONAL ROLE IN CAUSING THE MILKING OF THE DEVICE INTO THE RIGHT ATRIUM. ALTHOUGH BALLOON SIZING IS REQUIRED FOR ALL ASD CLOSURES, IT MAY NOT HAVE YIELDED ANY MEANINGFUL RESULTS IN THIS CASE. THIS WAS A CASE WHERE IT WOULD HAVE BEEN VERY DIFFICULT TO PREDICT THAT THE DEVICE WOULD EMBOLIZE AFTER RELEASE. THE MARGIN OF SAFETY OF A 38MM AMPLATZER SEPTAL OCCLUDER IS HIGH WITH THE LEFT ATRIAL DISC BEING 16MM LARGER AND THE RIGHT ATRIAL DISC BEING 10MM LARGER THAN THE WAIST.

    Description of Event or Problem · 1

    DURING AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE, A 38MM AMPLATZER SEPTAL OCCLUDER WAS PLACED WITHOUT INCIDENT. BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) THE DEVICE LOOKED TO BE IN VERY GOOD POSITION AND THE PATIENT WAS EXTUBATED. SHORTLY THEREAFTER, THE DEVICE WAS NOTED TO HAVE EMBOLIZED TO THE RIGHT ATRIUM. THE DEVICE WAS PERCUTANEOUSLY RETRIEVED WITH A SNARE AND THE PATIENT WAS REFERRED FOR ELECTIVE SURGICAL CLOSURE. THE PATIENT IS REPORTED TO BE STABLE AND AT HOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING IMAGING OF THE IMPLANT PROCEDURE, BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER AMPLATZER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-038 M06J19-23

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention