BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2549040 · Received April 19, 2012

    Report

    Report Number
    3005325609-2012-00010
    Event Type
    Other
    Date Received
    April 19, 2012
    Date of Event
    March 21, 2012
    Report Date
    March 21, 2012
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111766
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: ANGIO IMAGES AND THE STENT DELIVERY SYSTEM WERE RETURNED. IT WAS CONFIRMED THAT THE DETACHMENT OF THE TIP/LUMEN OCCURRED AT THE MELT COUPLER RATCHET BOND THAT SECURES THE CATHETER LUMEN TO THE RATCHET STEM. REVIEW OF THE ANGIO IMAGES CONFIRMED THAT THE STENT WAS NOT FULLY DEPLOYED PRIOR TO INITIATING DEVICE WITHDRAWAL PER THE IFU. WHEN THE THUMB SLIDE WAS RETRACTED PROXIMALLY AND LOCKED IN PLACE, THE TIP CLOSED TO THE DISTAL END OF THE CATHETER AND TRAPPED THE PROXIMAL PORTION OF THE STENT IN THE STENT DELIVERY CATHETER. AS THE STENT DELIVERY SYSTEM WAS BEING REMOVED THROUGH A PREVIOUSLY PLACED STENT IN THE EXTERNAL ILIAC AND THEN THOUGH THE INTRODUCER, THE STENT LENGTHENED AND BECAME LODGED IN THE INTRODUCER AS THERE WAS NOT ADEQUATE CLEARANCE FOR THE STENT AND THE TIP. EFFORTS TO DISENGAGE THE STENT FROM THE DELIVERY SYSTEM RESULTED IN A TIP/LUMEN DETACHMENT. THE PHYSICIAN DID NOT USE ADEQUATE MAGNIFICATION TO CONFIRM THE STENT WAS DEPLOYED FROM THE DELIVERY SYSTEM PRIOR TO INITIATING DEVICE WITHDRAWAL PER THE IFU. THE TIP WAS RETRIEVED WITH A SNARE WITH NO EFFECT TO THE PT. THE STENT WAS POST DILATED BUT REMAINED LONGER THAN NOMINAL LENGTH.

    Description of Event or Problem · 1

    THE PHYSICIAN DEPLOYED ANOTHER MFR'S STENT IN THE EXTERNAL ILIAC. DUE TO POOR FLUOROSCOPIC VISIBILITY (SET ON LOW MAGNIFICATION), THE PHYSICIAN MISTAKENLY DETERMINED THE STENT WAS FULLY DEPLOYED; HOWEVER, THERE WAS A SMALL AMOUNT STILL IN THE CATHETER. THE PHYSICIAN BEGAN TO EXTRACT THE CATHETER AND ELONGATED THE PROXIMAL PORTION OF THE STENT BACK INTO THE PREVIOUSLY DEPLOYED STENT AND THEN INTO THE SHEATH. THE PHYSICIAN REALIZED THE COMPLICATION ONLY AFTER THE CATHETER WAS INSIDE THE SHEATH. WITH MUCH FORCE, THE PHYSICIAN WAS ABLE TO RELEASE THE REMAINING PORTION OF THE STENT AND RETRACTED THE SHEATH A FEW CENTIMETERS. ONCE CONTRAST WAS USED, THE PHYSICIAN OBSERVED POOR FLOW AND HE ATTEMPTED TO CROSS A BALLOON. THE PHYSICIAN THEN MAGNIFIED THE VIEW AND NOTICED A DETACHED TIP. A SNARE WAS USED TO CAPTURE THE STENT WITH LITTLE EFFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-04-100-120-6F 01167054

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention 2.0X220 MUSTANG BALLOON| SHEATH: TERUMO DESTINATION (6FR, 90CM)| 8.0X39 GENESIS STENT (ILIAC STENT)| 3.0X220 MUSTANG BALLOON| 4.0X220 ANGIOSCORE BALLOON| 6X100 ANGIOSCORE BALLOON