BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2556441 · Received April 27, 2012

    Report

    Report Number
    3005325609-2012-00011
    Event Type
    Malfunction
    Date Received
    April 27, 2012
    Date of Event
    January 27, 2012
    Report Date
    March 26, 2012
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE INITIAL INFO FOR THIS EVENT WAS RECEIVED IT WAS NOT CONSIDERED A REPORTABLE EVENT. THE REPORTING DECISION WAS CHANGED FOLLOWING THE INVESTIGATION OF THE EVENT. ALTHOUGH THE EVENT OCCURRED IN (B)(6) 2012, THE DISTRIBUTOR IN (B)(4) DID NOT KNOW ABOUT THE EVENT UNTIL (B)(6) 2012. EVAL SUMMARY: THE CATHETER SYSTEM WAS NOT RETURNED; IT HAS BEEN DISCARDED. THE STENT, WITH THE TIP TRAPPED WITHIN THE INTRODUCER WERE RETURNED. REVIEW OF THE DHR RECORDS DID NOT INDICATE ANY ISSUES DURING MFG. REVIEW OF THE STENT LOADING PROCEDURES AND TOOLING DID NOT REVEAL THE POSSIBILITY OF WIRE DAMAGE DURING MFG. EXAM OF THE STENT REVEALED A DENT IN A DISTAL END WIRE. THE DIRECTION AND EXTREME DISTAL LOCATION OF THE DENTED WIRE IMPLIES THAT DEPLOYMENT OF THE STENT WAS INITIATED WITH THE FINAL DEPLOYMENT COLLAR OPEN (UNLOCKED). OPENING THE FINAL DEPLOYMENT COLLAR IS A FINAL STEP IN THE IFU STENT DEPLOYMENT INSTRUCTIONS BECAUSE IT ALLOWS THE THUMB SLIDE TO BE ADVANCED FULLY DISTALLY WHICH CAUSES THE RATCHET TO EXIT THE OUTER SHEATH FOR FINAL RELEASE OF THE PROXIMAL END OF THE STENT. IF THE COLLAR WAS OPENED AT THE INITIATION OF STENT DEPLOYMENT AND THE THUMB SLIDE ADVANCED FULLY DISTALLY, IT IS POSSIBLE THAT THE RATCHET MIGHT HAVE BECOME ENTANGLED WITHIN THE PREVIOUSLY DEPLOYED STENT AND EXERCISING OF THE THUMB SLIDE FOR STENT DEPLOYMENT POSSIBLY ENGAGED A DISTAL STENT END LOOP RESULTING IN THE DENTED WIRES AND IMPEDED FURTHER ADVANCEMENT OF THE STENT. THE INVESTIGATION CONCLUDED THAT WHEN THE PARTIALLY DEPLOYED STENT AND DELIVERY SYSTEM WERE WITHDRAWN INTO THE INTRODUCER, THE STENT BECAME WEDGED ALONG WITH THE CATHETER TIP IN THE INTRODUCER AS THE INNER DIAMETER OF THE INTRODUCER COULD NOT ACCOMMODATE THE OUTER DIAMETER OF THE TIP WITH THE ADDED THICKNESS OF THE SURROUNDING STENT WIRES. THERE HAS BEEN ONE PRIOR EVENT OF A LOSS OF RATCHETING EFFICIENT FOR THE SUPERA VERITAS 6F. THIS IS THE FIRST TIME A STENT KINK OF THIS MAGNITUDE AND IN THE NON-RATCHETING ZONE HAS BEEN OBSERVED. BECAUSE THE CATHETER SYSTEM WAS NOT RETURNED, THE ROOT CAUSE OF THE LOSS OF RATCHETING EFFICIENCY WAS NOT ASCERTAINED. THE CAUSE OF THE STENT WIRE KINK COULD NOT BE DETERMINED. THE DISTAL END OF THE STENT IS THE LAST PORTION LOADED INTO THE CATHETER AND DOES NOT COME INTO CONTACT WITH THE RATCHET ON THE STENT LOADER. ATTEMPTS TO OBTAIN FURTHER PROCEDURE INFO AND PT INFO WERE MADE, HOWEVER, NO FURTHER INFO WAS PROVIDED.

    Description of Event or Problem · 1

    A SUPERA STENT WAS PLACED IN THE POPLITEAL OF THE RIGHT LEG WITH NO ISSUES. ANOTHER SUPERA STENT WAS IN THE PROCESS OF BEING DEPLOYED BUT IT WOULD NOT ADVANCE OUT OF THE SHEATH MORE THAN 2CM. THE STENT AND TIP HAD BECAME TRAPPED IN THE INTRODUCER. THE SHEATH WAS ADVANCED TO RETRIEVE THE STENT AND REMOVE IT. AFTER REMOVING THE STENT, ANOTHER SUPERA STENT WAS PLACED WITH NO ISSUES. IT WAS FURTHER REPORTED THAT THERE WAS NO AFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. SE-05-200-120-6F 01119064

    Patients

    Seq Age Sex Outcome Treatment
    1