BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRASTENT TM DOUBLESTRUT TM LD

    MDR report key: 349280 · Received August 29, 2001

    Report

    Report Number
    2134479-2001-00002
    Event Type
    Injury
    Date Received
    August 29, 2001
    Date of Event
    March 9, 2001
    Report Date
    March 12, 2001
    Manufacturer
    SULZER INTRATHERAPEUTICS, INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN MOUNTED STENT ON BALLOON CATHETER. THE LOCATION FOR THE STENT TO BE PLACED WAS THE RIGHT PULMONARY ARTERY. WHEN THE BALLOON WAS INFLATED, ONLY THE DISTAL END OF THE BALLOON INFLATED, PUSHING THE STENT PROXIMALLY. THE STENT MOVED PROXIMALLY. THE PHYSICIAN ATTEMPTED TO GET THE BALLOON TO GO INTO THE STENT AGAIN IN ORDER TO MOVE IT BACK DISTALLY, AND FINISH OPENING THE STENT. THE BALLOON WOULD NOT GO BACK INTO THE STENT. THE PHYSICIAN USED A SNARE TO COMPRESS THE STENT BACK DOWN AND PULL IT INTO THE IVC. A CUT DOWN WAS PERFORMED ON THE FEMORAL ARTERY AND THE STENT WAS REMOVED. A CUTDOWN WAS NECESSARY TO MAKE THE HOLE IN THE VESSEL LARGE ENOUGH FOR THE STENT TO COME THOUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39374 INTRASTENT TM DOUBLESTRUT TM LD BILIARY CATHETER FGE SULZER INTRATHERAPEUTICS, INC. S15-16 MF2012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention ZMED BRAUN BALLOON PTA CATHETER.