BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER VASCULAR PLUG II

    MDR report key: 5943027 · Received September 12, 2016

    Report

    Report Number
    2135147-2016-00085
    Event Type
    Injury
    Date Received
    September 12, 2016
    Date of Event
    July 2, 2015
    Report Date
    August 29, 2016
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    KRD
    PMA / PMN Number
    K071125
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A 14MM AMPLATZER VASCULAR PLUG II (AVPII) WAS SELECTED TO EMBOLIZE IN THE LEFT SUBCLAVIAN ARTERY (LT-SCA) FOR THE TREATMENT OF THORACIC AORTIC ANEURYSM. THE AVPII WAS SUCCESSFULLY IMPLANTED WITH NO ISSUES. AT THE TIME OF THE 1-YEAR FOLLOW-UP ON (B)(6) 2015, THERE WERE NO ISSUES AND THE POSTOPERATIVE COURSE WAS UNEVENTFUL. ON (B)(6) 2015, AN ENDOLEAK FROM LT-SCA WAS CONFIRMED. COIL EMBOLIZATION INTO THE LT-SCA WAS PERFORMED ON THE SAME DAY AND THE PATIENT HAD A FAVORABLE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595367 AMPLATZER VASCULAR PLUG II ARTERIAL EMBOLIZATION DEVICE KRD AGA MEDICAL CORPORATION 9-AVP2-014 4121408

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R