BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH

    MDR report key: 2820603 · Received October 30, 2012

    Report

    Report Number
    1820334-2012-00484
    Event Type
    Injury
    Date Received
    October 30, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 2, 2012
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A (B)(6) MALE UNDERWENT EVAR FROM LOWEST RENAL TO EXTERNAL ILIACS USING A BI BRANCH ENDOVASCULAR GRAFT UP THE LEFT SIDE WITH A FLUENCY STENT THROUGH THE HELICAL BRANCH INTO THE LEFT INTERNAL ILIAC ARTERY. A CONTRALATERAL LEG EXTENSION WAS PLACED ON THE RIGHT. "PROXIMAL BI BRANCH PIECE PLACED UNEVENTFULLY. DISTAL BI BRANCH PIECE PLACED AND UNSHEATHED TO JUST BEYOND THE HELICAL ILIAC SIDEBRANCH. A NITINOL GLIDE WIRE WAS PASSED THROUGH BI BRANCH PRELOADED CATHETER AND SNARED FROM THE OTHER SIDE THROUGH THE 10FR SHEATH TO FORM A THRU'N'THRU WIRE. THE 10FR SHEATH DILATOR WAS THEN PASSED UP TO MEET THE TIP OF THE PRE-LOADED CATHETER AND THE WIRE CLAMPED AT BOTH ENDS. THE SURGEONS HAD SIGNIFICANT DIFFICULTY GETTING THE 10FR SHEATH TO TRACK THROUGH THE 'TRAP DOOR' (SELF CLOSING FLAP) ON THE BI BRANCH DEVICE. HOWEVER, IT DID EVENTUALLY PASS WITH A COMBINATION OF WITHDRAWING THE PRELOADED CATHETER, ADVANCING THE 10FR SHEATH AND PUSHING ON THE PT'S ABDOMEN TO MANIPULATE THE POSITION OF THE AORTA. THEN THE TIP OF THE 10FR SHEATH WAS POSITIONED AT THE DISTAL END OF THE HELICAL SIDE BRANCH OF THE BI BRANCH DEVICE BUT WOULD NOT GO ANY FURTHER. AN OFF CENTER PUNCTURE WAS MADE IN THE VALVE OF THE 10FR SHEATH AND A CATHETER/WIRE COMBINATION USED TO CANNULATE THE INTERNAL ILIAC. A FLUENCY STENT WAS PASSED THROUGH THE SHEATH BUT THE SURGEONS HAD GREAT DIFFICULTY GETTING IT TO TRACK INTO THE INTERNAL ILIAC AS IT SEEMED TO BE GETTING CAUGHT AT THE DISTAL END OF THE HELICAL BRANCH. THE STENT WAS REMOVED AND A 8MMX20MM BALLOON INFLATED IN THIS AREA SEVERAL TIMES. THE BALLOON WAS DEFLATED AND REMOVED BEFORE THE STENT WAS RETURNED AND TRACKED NICELY THIS TIME INTO THE DESIRED POSITION AND DEPLOYED IN THE INTERNAL ILIAC AND HELICAL SIDE BRANCH. TROUBLE AROUSE WHEN IT CAME TIME TO REMOVE THE 10FR SHEATH. THE SURGEONS WITHDREW THE SHEATH THROUGH THE 'TRAP DOOR' HOWEVER THE RADIOPAQUE TIP MUST HAVE BECOME STUCK AT THIS POINT AND THE BRAIDING ON THE SHEATH UNRAVELED. THE SHEATH WAS REMOVED, BUT A COIL OF WIRE EXPOSED. THE RADIOPAQUE CIRCULAR BAND STAYED INSIDE THE PT. THE SURGEONS DECIDED TO PLACE ANOTHER MFR'S COVERED STENT TO TRAP IT AGAINST THE WALL OF THE GRAFT JUST BELOW THE 'TRAP DOOR'. REVIEWING THE DEMO GRAFT AND DISCUSSING THE CASE AFTERWARDS THE DR'S FELT THAT THE TRAP DOOR FENESTRATION SHOULD BE LARGER. THEY ALSO THROUGH THE STENT AT THE DISTAL OPENING OF THE HELICAL BRANCH OUGHT TO BE ON THE INSIDE OF THE GRAFT (SEALING STENT) AS WELL AS THE GOLD MARKER, AS THEY MAY HAVE CONTRIBUTED TO THE FLUENCY STENT GETTING STUCK AND NOT TRACKING INTO THE INTERNAL ILIAC. NO ADVERSE EFFECTS TO THE PT WERE REPORTED DUE TO THIS OCCURRENCE. EVENT EVAL: IMAGES HAVE BEEN SENT FOR EXTERNAL CLINICAL REVIEW. STILL UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA 2759285

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention