BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER VASCULAR PLUG

    MDR report key: 1250943 · Received December 5, 2008

    Report

    Report Number
    2135147-2008-00127
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    January 1, 2007
    Report Date
    December 4, 2007
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    KRD
    PMA / PMN Number
    K031810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN RESPONSE TO THE ARTICLE, ''INITIAL CLINICAL EXPERIENCE USING THE AMPLATZER VASCULAR PLUG,'' BY TUITE ET AL., THE LETTER TO THE EDITOR RESPONSE REPORTED THE FOLLOWING EVENT: A MALE PATIENT PRESENTED TO OUR DEPARTMENT FOLLOWING SUCCESSFUL STENT-GRAFT REPAIR OF A THORACOABDOMINAL AORTIC ANEURYSM USING A HYBRID TECHNIQUE. A THORACIC STENT GRAFT WAS PLACED IN THE DESCENDING THORACIC AORTA AND EXTENDED DOWN INTO A PREVIOUSLY PLACED SURGICAL GRAFT BELOW THE LEVEL OF THE VISCERAL ARTERIES. THE SUPERIOR MESENTERIC ARTERY (SMA) HAD BEEN EMBOLIZED PREOPERATIVELY WITH TWO AMPLATZER VASCULAR PLUGS AND THE VISCERAL ARTERIES HAD BEEN REVASCULARIZED WITH SURGICALLY PLACED GRAFTS TO THE HEPATIC ARTERY, A BRANCH OF THE SMA, AND THE RIGHT RENAL ARTERY. FOLLOW-UP CT ANGIOGRAPHY 6 WEEKS POSTOPERATIVELY REVEALED A LARGE TYPE 2 ENDOLEAK FROM THE SMA WITH CONTINUED PERFUSION THROUGH THE OCCLUDERS. CATHETER ANGIOGRAPHY DEMONSTRATED THE ENDOLEAK AND PLACEMENT OF TWO 8-MM NESTER EMBOLIZATION COILS WAS RELATIVELY STRAIGHTFORWARD UP AGAINST THE OCCLUDERS. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER VASCULAR PLUG ARTERIAL EMBOLIZATION DEVICE KRD AGA MEDICAL CORPORATION 9-PLUG-000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention