BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 1226508 · Received November 11, 2008

    Report

    Report Number
    3005325609-2008-00004
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 23, 2008
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K071646
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND THEIR WERE NO NOTED ANOMALIES DURING MANUFACTURING. COMPLAINT FILES WERE REVIEWED AND THERE HAVE BEEN 4 PREVIOUS SIMILAR EVENTS REPORTED. ANOTHER DEVICE THAT WAS INVOLVED IN A PREVIOUS SIMILAR EVENT USING THE SAME ACCESSORIES WAS RETURNED AND ANALYZED. IN THAT CASE, THE STENT DELIVERY CATHETER AND THE INTRODUCER SHEATH (ANOTHER MANUFACTURERS) WERE RETURNED. THE SUPERA STENT DELIVERY CATHETER'S DIMENSIONS WERE MEASURED AND FOUND TO BE WITHIN ITS SPECIFICATIONS. THE INTRODUCER SHEATH WAS MEASURED AND FOUND TO BE BELOW ITS LABELED NOMINAL DIMENSION. IT IS UNKNOWN WHAT THE MINIMUM AND MAXIMUM DIMENSIONS ARE FOR THE INTRODUCER SHEATH. ANALYSIS CONCLUDED THAT WHEN THE SUPERA CATHETER IS PLACED INTO THE INTRODUCER SHEATH, IT WASN'T ABLE TO MOVE FREELY. THIS RESULTED IN THE SHEATH CATCHING THE MARKER BANDS CAUSING THEM TO MOVE ON THE CATHETER. THE MFR OF THE INTRODUCER SHEATH HAS BEEN INFORMED OF THESE EVENTS.

    Description of Event or Problem · 1

    WHILE REMOVING THE CATHETER AFTER DELIVERING THE STENT TO THE SFA, THE MARKER BANDS ON THE CATHETER DISLODGED AND TRAVELED INTO THE PT'S SFA AND TP TRUNK. THE PHYSICIAN INSERTED TWO BALLOONS AND SUCCESSFULLY RETRIEVED BOTH THE MARKER BANDS. IT WAS ALSO REPORTED THAT THE STENT ELONGATED WHEN IT WAS PLACED. THE VESSEL WAS PATENT FOLLOWING STENT PLACEMENT AND THERE WAS NO EFFECT ON THE PT. THE TARGET VESSEL WAS REPORTED TO BE MODERATELY CALCIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-05-60-120-G2 F00232

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention PINNACLE DESTINATION INTRODUCER SHEATH (7FR)| VS5 018 GUIDEWIRE