BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 1243743 · Received November 25, 2008

    Report

    Report Number
    3005325609-2008-00005
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 3, 2008
    Manufacturer
    IDEV TECHNOLOGIES, INC
    Product Code
    FGE
    PMA / PMN Number
    K071646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER SYSTEM WAS RETURNED AND ANALYZED. THE RATCHET SHAFT HAD BEEN REMOVED FROM THE HYPOTUDE DURING THE IMPLANT PROCEDURE. SINCE THERE WAS NO OBSERVED RATCHET ISSUES DURING THE IMPLANT, IT IS ASSUMED THAT THE RATCHET SHAFT PERFORMED AS INTENDED. THE RATCHET WAS INSPECTED UNDER MAGNIFICATION AND THERE WERE NO ANOMALIES OBSERVED. THE RATCHET WIDTH WAS WITHIN SPEC. A VIDEO OF THE PROCEDURE WAS ALSO RECEIVED AND REVIEWED. UPON REVIEWING THE ANGIOGRAMS, IT APPEARS THAT THE STENT MAY HAVE INVERTED WITHIN ITSELF. AS STATED IN THE INITIAL REPORT, THE PHYSICIAN REALIZED THAT THERE WAS A PORTION OF THE STENT LEFT IN THE DELIVERY SYSTEM WHEN HE FIRST ATTEMPTED TO REMOVE THE CATHETER. IT IS SPECULATED THAT THERE WAS MORE STENT LEFT THAN INTENDED IN THE DELIVERY SYSTEM AND THAT UPON TAKING THE LAST FULL STROKE, THERE MAY HAVE BEEN NEARLY A FULL STROKE OF STENT IN THE DELIVERY CATHETER. IF THIS WERE THE CASE, WHILE PERFORMING THE LAST STROKE, THE CATHETER WAS NOT PULLED BACK. THE REMAINING STENT PORTION EXPELLED FROM THE CATHETER AND HAD NO WHERE TO GO EXPECT INSIDE THE PARTIALLY DEPLOYED STENT RESULTING IN THE INVERTED CONFIGURATION.

    Description of Event or Problem · 1

    AFTER DEPLOYING THE STENT INTO THE ADDUCTOR CANAL REGION, THE STENT APPEARED TO BE TWISTED UNDER ANGIOGRAPH. IT WAS DESCRIBED TO LOOK LIKE A "TANGLED WIRE." THE PHYSICIAN WAS UNABLE TO PASS THE FLEXIBLE TIP THROUGH FOR REMOVAL OF THE DELIVERY CATHETER. PRIOR TO THIS ISSUE, THE PHYSICIAN HAD USED VERY SLOW STENT DEPLOYMENT TECHNIQUE. THE PHYSICIAN THOUGHT THAT THE STENT WAS COMPLETELY DEPLOYED AND BEGAN PULLING THE TIP BACK, BUT REALIZED A SMALL PORTION OF THE STENT WAS NOT YET DELIVERED. THE TIP HAD NOT YET REACHED THE DELIVERY SHEATH AND WAS RE-ADVANCED. THE STENT DELIVERY WAS COMPLETED. HOWEVER, THE TIP BECAME STUCK ON THE DISTAL SIDE OF THE "TANGLED" STENT. THE PHYSICIAN PROCEEDED TO CUT THE OUTER SHEATH OF THE DELIVERY CATHETER LENGTH WISE AND PEELED IT AWAY LEAVING THE GUIDEWIRE LUMEN IN THE 7FR. SHEATH. THIS PROVIDED ENOUGH ROOM TO PASS A .014 WIRE THROUGH THE PROXIMAL SEGMENT OF THE STENT. A BALLOON WAS PASSED OVER THE .014 WIRE AND USED TO EXPAND AND TACK THE STENT TO THE VESSEL WALL WHICH PROVIDED ACCESS FOR THE TIP TO COME THROUGH AND REMOVAL OF THE DELIVERY SYSTEM. THE PHYSICIAN THEN USED ANOTHER STENT TO COVER THE ABNORMAL AREA (APPROXIMATELY .75CM). THE FINAL ANGIOGRAPHIC RESULT WAS GOOD AND THERE WAS NO EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC S-05-40-120-G2 F00244

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR PINNACLE DESTINATION INTRODUCER SHEATH (7FR)