BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2152195 · Received June 23, 2011

    Report

    Report Number
    3005325609-2011-00009
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 27, 2011
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K093893
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A PREVIOUS SIMILAR REPORTED EVENT, CAPA (B)(4) WAS OPENED AND ACTION TAKEN TO REVISE THE MANUFACTURING PROCESS FOR STENT LOADING. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT FOR THIS EVENT AND THE 1ST EVENT, THE DEVICES WERE MANUFACTURED WITHIN A TWO WEEK TIME FRAME. THE ROOT CAUSE OF TIP ENTRAPMENT IN THE STENT LOOP WAS MOST LIKELY CAUSED BY A MANUFACTURING PROCESS ERROR DURING STENT AND CATHETER SHAFT LOADING. THE CORRECTIVE ACTION IS IN THE VERIFICATION PROCESS. THE CAUSE OF ELONGATING THE STENT WAS DUE TO THE MANIPULATION OF THE CATHETER SYSTEM WHILE ATTEMPTING TO REMOVE THE CATHETER. APPROXIMATELY (B)(4) SUPERA VERITAS STENT DELIVERY SYSTEMS HAVE BEEN DISTRIBUTED RESULTING IN A (B)(4) EVENT RATE FOR THIS MALFUNCTION. ADDITIONALLY, APPROXIMATELY 1000 DEVICES HAVE BEEN MANUFACTURED AND TESTED FOR R&D WITH NO OCCURRENCES OF THIS EVENT. (PATIENT INFORMATION) ARE NOT COMPLETE. ATTEMPTS TO OBTAIN THIS INFORMATION HAVE BEEN MADE. THE PHYSICIAN SITES THE HIPAA REGULATION AND TO DATE HAS NOT PROVIDED THIS INFORMATION.

    Description of Event or Problem · 1

    THIS WAS THE PHYSICIAN'S FIRST PROCEDURE WITH THIS PRODUCT. THE STENT WAS SUCCESSFULLY PLACED IN THE SFA. THE PROBLEM OCCURRED WHILE ATTEMPTING TO REMOVE THE CATHETER FOLLOWING DEPLOYMENT. THE SYSTEM LOCK WAS NOT PROPERLY ROTATED (LOCKED) PRIOR TO ATTEMPTING REMOVAL OF THE CATHETER. THE STENTED AREA WAS EXAMINED UNDER FLUOROSCOPY AND IT WAS OBSERVED THAT THE STENT HAD BEEN STRETCHED PAST THE PROFUNDA/SFA BIFURCATION APPROXIMATELY 20MM PROXIMAL. AFTER ENSURING THAT THE SYSTEM LOCK WAS IN THE PROPER POSITION, THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER. AFTER REPEATED ATTEMPTS AT MANEUVERING THE CATHETER TIP, THE TIP WAS OBSERVED TO BE ENSNARED IN THE STENT. A BALLOON WAS INSERTED AND THE AREA WAS INFLATED AND AFTER CONTINUED MOVEMENTS OF THE CATHETER TIP, IT WAS REMOVED FROM THE PATIENT AND WAS INTACT. THE STENTED AREA WAS THEN OBSERVED UNDER ANGIOGRAPHY AND ALTHOUGH THE PLACEMENT WAS NOT IDEAL, ACCORDING TO THE PHYSICIAN, THE AREA WAS PATENT AND THE PATIENT WAS SHOWING NO COMPLICATIONS. HOWEVER, THE PHYSICIAN WAS CONCERNED ABOUT FUTURE COMPLICATIONS DUE TO THE PLACEMENT AND THE STENT SLIGHTLY ELONGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-05-060-120-G3 01042035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EV3 EVERCROSS BALLOON: 6X40