BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPRA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2887196 · Received December 20, 2012

    Report

    Report Number
    3005325609-2012-00037
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND ANALYZED. THE TIP OVERMOLD HAD DETACHED FROM THE TIP LUMEN. DAMAGE IN THE OUTER SHEATH PEBAX WAS OBSERVED AND WAS DUE TO THE RATCHET TO SHEATH INTERACTION. BASED ON REVIEW OF THE CALCIFIED VESSEL IMAGE, VESSEL RECOIL THAT OCCURRED AFTER VESSEL PREPARATION USING PTA WITH MULTIPLE BALLOONS, THE INVESTIGATION CONCLUDED THAT THE TIP OVERMOLD LIKELY DETACHED DUE TO INTERACTION WITH EITHER VESSEL CALCIFICATION OR DUE TO INTERACTION WITH THE STENT. THE CAUSE OF THE OUTER SHEATH PEBAX DAMAGE OCCURRED DUE TO RATCHET-TO-SHEATH INTERACTION THAT WAS LIKELY FROM THE HEAVY CALCIFICATION AND VESSEL RECOIL AFTER VESSEL PREPARATION. A CAPA FOR THE TIP DETACHMENT EVENTS WAS OPENED RESULTING IN A DEVICE MODIFICATION TO DECREASE THE RATE OF THESE TYPE OF EVENTS. FDA 510 (K) CLEARANCE (K122546) FOR THIS MODIFICATION WAS RECEIVED ON (B)(4) 2012. A CAPA FOR THE RATCHET-TO-SHEATH INTERACTION WAS ALSO OPENED AND IS IN PROCESS. THE RATCHET-TO-SHEATH INTERACTION IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF IT WERE TO RECUR. THE DISTRIBUTOR REPORTED THAT THE PATIENT'S WEIGHT WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN BELGIUM. THE SFA AND POPLITEAL ARTERIES WERE PREDILATED WITH A 5MM BALLOON. HOWEVER, AFTER PTA, VESSEL RECOIL WAS OBSERVED AND A 5X200MM SUPERA STENT WAS PLACE. UPON RELEASE OF THE STENT, THE PHYSICIAN SAW THAT THE TIP OF THE CATHETER HAD DETACHED. THE PHYSICIAN STATED THAT THE DETACHMENT WAS DUE TO THE SEVERE CALCIFICATION. THE TIP ASSEMBLY WAS STILL ON THE GUIDEWIRE AND RETRIEVED WITH A SNARE. A SECOND STENT WAS USED TO COVER THE LESION. POSTIDILATION WAS PERFORMED AND THE ANGIOGRAM SHOWED GOOD BLOOD FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPRA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. SE-05-200-120-6F 01206064

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention POST DILATION BALLOON: FOX SV 5MM| GUIDEWIRE: TERUMO| BALLOON: PASSEO| BERENSTEIN CATHETER