BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICAST COVERED STENT

    MDR report key: 2963648 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00084
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    JCT
    PMA / PMN Number
    K050814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REVIEWING THE INFO IT APPEARS THAT THERE WERE TECHNICAL USER ERRORS. THE PHYSICIAN WAS UNSUCCESSFUL IN CROSSING THE LESION WITH THE ORIGINAL WIRE AND NO PTA WAS PERFORMED ON THE LESION TO MAKE PASSAGE EASIER. SINCE THE ICAST HAD ALREADY TRACKED THROUGH THE INTRODUCER AND VESSEL ORIGINALLY AND THEN IT WAS REMOVED THROUGH THE INTRODUCER AND THEN RE-INSERTED A SECOND TIME THROUGH THE INTRODUCER, THERE IS A CHANCE THAT THE ICAST BECAME FLARED AND DISLODGED FORM THE BALLOON. THE ICAST CATHETER WAS THEN RE-ADVANCED TO THE LESION SITE WHERE MOST LIKELY THE STENT HAD ALREADY BEEN DISLODGED FORM THE BALLOON. THE BALLOON WAS INFLATED AND RUPTURED, MOST LIKELY FORM THE BALLOON EITHER COMING IN CONTACT WITH THE STIFF WIRE OR THE HARD CALCIFIED PLAQUE. THE PHYSICIAN ATTEMPTED TO REMOVE THE ICAST CATHETER WITH THE RUPTURED BALLOON WHICH SEEMS TO HAVE CAUGHT ON THE UNDEPLOYED STENT AND THE INTRODUCER WHICH RESULTED IN THE BALLOON/SHAFT PULLING AWAY FORM THE MAIN CATHETER SHAFT.

    Description of Event or Problem · 1

    ADVANCED 8X59 ICAST OVER .035" ZIP WIRE WITH SOME RESISTANCE IN EXTERNAL ILIAC ARTERY. PHYSICIAN CHOSE TO EXCHANGE WIRE OUT FOR A STIFFER WIRE (BENSON WIRE). ICAST REMOVED FROM THE PT AND WAS INTACT ON THE BALLOON IN-BETWEEN RADIOPAQUE MARKERS. ICAST READVANCED INTO RIGHT COMMON ILIAC ARTERY. UPON INFLATION OF THE BALLOON (AT APPROX 8ATM), THE BALLOON RUPTURED. AT THIS POINT THE STENT WAS IN THE EXTERNAL ILIAC ARTERY, JAILING OFF THE INTERNAL ILIAC. PHYSICIAN REMOVED THE ICAST CATHETER FROM THE PT AND THE BALLOON WASN'T ATTACHED. THE BALLOON REMAINED PROXIMAL TO THE STENT IN THE EXTERNAL ILIAC ARTERY. PHYSICIAN ATTEMPTED TO USE A PTA BALLOON TO GRAB HOLD OF THE STENT AND REMOVE IT WITHOUT SUCCESS. IT WAS SUGGESTED TO USE A WIRE TO SNARE AT THIS POINT, BUT PHYSICIAN WAS CONCERNED ABOUT DAMAGING THE VESSEL AND DECIDED TO DO A FEM/FEM BYPASS. AFTER THE BYPASS WAS COMPLETED, HE PLACED ANOTHER SHEATH IN THE RIGHT CENTRAL FEMORAL ARTERY AND WAS ABLE TO USE PTA BALLOON TO REMOVE THE REST OF THE STENT AND BALLOON. ONCE REMOVED, THE STENT WAS INTACT. BALLOON WAS SHEARED AT ONE END AND HAD SEPARATED COMPLETELY FROM THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628 ICAST COVERED STENT JCT ATRIUM MEDICAL CORP. 85417 10421539

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ZIPWIRE (CHANGED TO BENSON WIRE) .035"| PINNACLE DESTINATION SHEATH 7FR