BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER

    MDR report key: 8790997 · Received July 15, 2019

    Report

    Report Number
    2135147-2019-00211
    Event Type
    Injury
    Date Received
    July 15, 2019
    Date of Event
    June 12, 2019
    Report Date
    September 13, 2019
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    OZH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF DEFORMITY UPON DEPLOYMENT COULD NOT BE CONFIRMED. THE INVESTIGATION CONFIRMED THE DEVICE MET FUNCTIONAL SPECIFICATIONS WHEN ANALYZED AT ABBOTT UNDER NON-PHYSIOLOGICAL CONDITIONS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF COMMERCIALIZATION. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER, PER THE SITE THE PHYSICIAN SUSPECTED THE DEFORMATION WAS DUE TO AN INTERACTION WITH THE ICD LEAD.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A 22MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER WAS SELECTED TO CLOSE A POST-INFARCT VSD. THE DEVICE WAS REPORTED TO HAVE DEPLOYED IN A "COBRA" FORMATION AND WAS EXCHANGED FOR ANOTHER 22MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER. HOWEVER, THE SECOND DEVICE ALSO DEPLOYED IN A "COBRA" FORMATION. THE PHYSICIAN SUSPECTS THE DEFORMATION WAS DUE TO AN INTERACTION WITH THE ICD LEAD AND HE ELECTED TO DEPLOY AN UNKNOWN 20MM DEVICE FAR FROM THE ICD LEAD AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO FURTHER ISSUES REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A 22MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER WAS SELECTED TO CLOSE A POST-INFARCT VSD. THE DEVICE WAS REPORTED TO HAVE DEPLOYED IN A "COBRA" FORMATION AND WAS EXCHANGED FOR ANOTHER 22MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER. HOWEVER, THE SECOND DEVICE ALSO DEPLOYED IN A "COBRA" FORMATION. THE PHYSICIAN SUSPECTS THE DEFORMATION WAS DUE TO AN INTERACTION WITH THE ICD LEAD AND HE ELECTED TO DEPLOY A 20MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER (LOT NUMBER: 18044472) FAR FROM THE ICD LEAD AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO FURTHER ISSUES REPORTED. THE PATIENT IS REPORTED TO BE STABLE IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584149 AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER OZH AGA MEDICAL CORPORATION 9-VSDMPIHDE-022 16708865

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R