BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRIDGEX3 BILIARY STENT

    MDR report key: 555017 · Received September 22, 2004

    Report

    Report Number
    555017
    Event Type
    Other
    Date Received
    September 22, 2004
    Date of Event
    August 20, 2004
    Report Date
    September 22, 2004
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    FGE
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORT OF 75% STENOSIS OF RIGHT RENAL ARTERY. PROCEEDED WITH ANGIOPLASTY OF RIGHT RENAL ARTERY. A SHEPHARD'S HOOK CATHETER WAS USED TO CANNULATE THE RENAL ARTERY. A SV5 GUIDEWIRE SIZE 0.018 WAS ADVANCED AND THE LESION IN THE RIGHT RENAL ARTERY WAS CROSSED WITHOUT DIFFICULTY. A PERIPHERAL BALLOON SIZE 5 X 40 MILLIMETERS WAS ADVANCED AND THE RIGHT RENAL STENOSIS WAS DILATED UP TO A PRESSURE OF EIGHT BARS FOR A DURATION OF 2 MINUTES. REPEAT INJECTIONS SHOWED A WIDELY PATENT RIGHT RENAL ARTERY. THEREAFTER, ATTEMPTS TO DEPLOY A BRIDGE STENT TO THE RIGHT RENAL ARTERY WERE UNSUCCESSFUL. THE STENT WAS DISLODGED FROM THE BALLOON CATHETER DURING THE PROCEDURE. WAS ABLE TO SNARE THE STENT INTO THE TIP OF THE FEMORAL SHEATH AND PULL THE SHEATH AND THE STENT ONTO THE RIGHT FEMORAL PUNCTURE SITE. UNABLE TO REMOVE STENT FROM THE RIGHT COMMON FEMORAL ARTERY PUNCTURE SITE. PATIENT TRANSFERRED TO SURGERY AND STENT REMOVED. PATIENT DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIDGEX3 BILIARY STENT STENT FGE MEDTRONIC VASCULAR * 192988

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR