BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 1387029 · Received May 15, 2009

    Report

    Report Number
    3005325609-2009-00004
    Event Type
    Injury
    Date Received
    May 15, 2009
    Date of Event
    April 16, 2009
    Report Date
    April 16, 2009
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K071646
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND ANALYZED. THE INVESTIGATION CONCLUDED THE FOLLOWING: THE VESSEL WAS NOT PROPERLY PREPPED. A 50CC SYRINGE WAS USED TO INFLATE A BALLOON TO PREP THE VESSEL FOR PROPER LUMEN DIAMETER. A 50CC SYRINGE WOULD NOT HAVE BEEN ADEQUATE TO OPEN THE VESSEL FOR THE 6MM STENT. THE VESSEL WAS NOT PREPPED AND THE STENT WAS NOT SIZED PER THE INSTRUCTIONS FOR USE. THIS WAS LIKELY THE CAUSE OF THIS EVENT. THIS WAS THE PHYSICIAN'S FIRST TIME USING THE SUPERA DEVICE IN A CLINICAL SETTING. A 150MM STENT WAS BEING USED WHICH MAY BE MORE DIFFICULT TO PLACE THAN THE SHORTER STENTS. THE PROPER TECHNIQUE MAY NOT HAVE BEEN USED WHEN ADVANCING THE STENT. THE INTRODUCER SHEATH (ANOTHER MANUFACTURER'S) MAY HAVE CONTRIBUTED TO THE DEPLOYMENT RESISTANCE. THE SHEATH MAY HAVE KINKED AT THE BIFURCATION. THE ADDITIONAL FORCE APPLIED BY THE PHYSICIAN TO DEPLOY THE STENT CAUSED THE THUMBSLIDE TO BREAK. THE INABILITY TO DEPLOY THE STENT REQUIRED THE PHYSICIAN TO REMOVE THE PARTIALLY DEPLOYED STENT. REMOVAL OF THE STENT DISLODGED THE PLAQUE WHICH SUBSEQUENTLY BLOCKED THE BIFURCATION OF THE ANTERIOR TIBIAL AND POSTERIOR TIBIAL. DEVICE ANALYSIS CONFIRMED THAT THE RATCHET MECHANISM WAS IN SPEC. PLACING A STENT TO OPEN THE BLOCKED ARTERY WAS DONE. DEVICE HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE NOTED THAT WOULD HAVE LEAD TO THE REPORTED EVENT. THE DEVICE WAS IMPLANTED IN ANOTHER COUNTRY. THE DEVICE HOLDS THE CE MARK FOR THE FOLLOWING INDICATION: PALLIATIVE TREATMENT OF BILIARY STRICTURES PRODUCED BY MALIGNANT NEOPLASMS AND PERIPHERAL VASCULAR USE FOLLOWING FAILED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). RETRAINING WILL BE PROVIDED FOR THIS PHYSICIAN.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS DEPLOYING A 6MM X 150MM STENT INTO THE SFA WHEN HE BEGAN TO FEEL RESISTANCE WHICH CAUSED HIM TO APPLY MORE FORCE THAT ULTIMATELY RESULTED IN A BROKEN THUMBSLIDE. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO FINISH THE DEPLOYMENT BY PULLING AND PUSHING ON THE CATHETER. IT WAS DECIDED TO PULL THE CATHETER SYSTEM OUT BECAUSE THE STENT COULD NOT BE RECOVERED AND HAD MOVED TOO HIGH INTO THE SFA. PULLING THE CATHETER OUT WITH A PARTIALLY DEPLOYED STENT CAUSED SOME PLAGUE TO DISLODGE FROM THE VESSEL. THE PLAGUE TRAVELED DISTALLY DOWN THE SFA AND BECAME BLOCKED AT THE BIFURCATION OF THE ANTERIOR TIBIAL AND POSTERIOR TIBIAL STOPPING BLOOD FLOW RESULTING IN A COLD FOOT. THE PHYSICIAN ATTEMPTED TO REMOVE THE BLOCKAGE BY BALLOONING AND ANGIO JET. THE PHYSICIAN ENDED UP USING A SMALL STENT TO SECURE THE DISLODGED PLAGUE AND OPEN UP THE BLOCKED ARTERY. THE PROCEDURE CONTINUED AND WAS COMPLETED BY STENTING THE INITIAL TARGET LESION WITH TWO STANDARD SIZED STENTS RATHER THAN ONE LENGTHY STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-06-150-120-G2 F00235

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention CORDIS 7FR SHEATH