BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMUS GPS STENT

    MDR report key: 669421 · Received January 26, 2006

    Report

    Report Number
    2183870-2006-00003
    Event Type
    Malfunction
    Date Received
    January 26, 2006
    Date of Event
    December 27, 2005
    Manufacturer
    *
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE BALLOON WAS UNABLE TO BE BROUGHT BACK INTO THE STENT. THE STENT PULLED FURTHER AND PLACED FURTHER INTO THE AORTA THAN THE DR PREFERRED. ADDITIONAL INFO RECEIVED FROM MEDICAL IMAGING 1/25/2006: ARTERIOGRAM WITH LEFT SUBCLAVIAN ANGIOPLASTY AND STENT PLACEMENT. ACCESS SITE: LEFT COMMON FEMORAL ARTERY. PLACEMENT OF A 10MMX37MM BALLOON EXPANDABLE STENT ACROSS A LEFT SUBCLAVIAN PROXIMAL STENOSIS. SLIGHT INFERIOR MIGRATION OF THE BALLOON EXPANDABLE STENT UPON DEFLATION OF THE BALLOON WHICH PROTRUDES SLIGHTLY INTO THE AORTA ON OBLIQUE IMAGING HOWEVER, DOES APPEAR TO COMPLETELY COVER THE STENOSIS AND THERE IS PRESERVED ANTEGRADE FLOW IN THE LEFT VERTEBRAL AND LEFT INTERNAL MAMMARY ARTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMUS GPS STENT FGE FGE * BXB35-10-37-120 1050320

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR