BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 1266513 · Received December 17, 2008

    Report

    Report Number
    3005325609-2008-00007
    Event Type
    Injury
    Date Received
    December 17, 2008
    Date of Event
    November 17, 2008
    Report Date
    November 17, 2008
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K071646
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, HOWEVER, IT IS EXPECTED TO BE RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON ANALYSIS OF THE DEVICE.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE PATIENT HAD AN OCCLUDED SFA WITH SUBINTIMAL TRACK. AN UNSUCCESSFUL ANGIOPLASTY WAS PERFORMED, THEREFORE, THE PHYSICIAN DECIDED TO PLACE A STENT FOR TREATMENT (CATHETER WAS PLACED OVER THE BIFURCATION AND DOWN THROUGH THE HUNTER CANAL IN THE DISTAL SFA). A 6MMX150MM STENT WAS CHOSEN TREAT THE LESION. THE PHYSICIAN HAD DIFFICULTY WHEN ATTEMPTING TO ADVANCE THE TIP OF THE CATHETER INTO THE VESSEL DUE TO THE TIGHTNESS OF THE VESSEL. THE REPORTER STATED THAT THE FIRST SECTION OF THE STENT DEPLOYED OK BUT WHEN IT REACHED A TIGHT SECTION OF THE SFA, THE STENT ELONGATED AND DEPLOYED ACROSS INTO THE COMMON FEMORAL ARTERY AND THEN ACROSS THE PROFUNDA ARTERY. IT WAS ALSO NOTED THAT THE RATCHET SLIPPED DURING THIS PROCEDURE. FURTHER INFORMATION RECEIVED INDICATED THAT THE STENT MAY HAVE BEEN UNDERSIZED FOR THE TARGET VESSEL WHICH RESULTED IN AN ELONGATED STENT. TWO WEEKS FOLLOWING THE IMPLANT, THE PATIENT PRESENTED WITH AN ACUTE ISCHEMIC LEG. THE ARTERY WAS OCCLUDED WHICH REQUIRED SURGERY. SURGICAL REMOVAL OF THE STENT AND BYPASS WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-06-150-120-G2 F00235

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention