BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 3202073 · Received June 27, 2013

    Report

    Report Number
    3005325609-2013-00019
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 31, 2013
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE THUMB SLIDE WAS IN THE CORRECT POSITION, HOWEVER, IT WAS NOT LOCKED AS INSTRUCTED BY THE IFU. THE DEVICE DEPLOYMENT MECHANISM WAS EXERCISED AND THERE WERE NO ISSUES. THE DEVICE WAS EXAMINED UNDER (B)(4) MAGNIFICATION TO LOOK FOR EXTERNAL FLAWS. THE DISTAL END OF THE OUTER SHEATH WHICH WAS DAMAGED AND FLARED. THE DAMAGE TO THE DISTAL END OF THE SHEATH IS LIKELY DUE TO INTERACTION OF THE SHEATH WITH THE STENT WIRE CROSSING AND INSIDE DIAMETER OF THE ELONGATED STENT. UNDER (B)(4) MAGNIFICATION, THE PROXIMAL END OF THE TIP OVERMOLD THAT TRANSITIONS TO THE TIP LUMEN WAS OBSERVED TO BE LIFTED. THE DEVICE'S MFG RECORDS WERE REVIEWED AND NO ANOMALIES WERE NOTED. PROCEDURE ANGIOGRAMS REVIEWED BY THE IDEV REP AND THE PHYSICIAN SHOWED "SIGNIFICANT" ELONGATION OF THE STENT; THE EXACT LENGTH COULD NOT BE CONFIRMED. THE CAUSE OF THE ELONGATED STENT WAS DUE TO THE INCORRECT STENT SIZING. THE PHYSICIAN OVERSIZED THE STENT TO THE REF VESSEL DIAMETER WHICH IS NOT IN ACCORDANCE WITH THE IFU. THE TIP DETACHMENT OCCURRED DUE TO TIP INTERACTION WITH THE ELONGATED STENT. THE CAUSES OF THE EVENT HAVE BEEN REVIEWED WITH THE PHYSICIAN BY AN IDEV REPS AND THE PHYSICIAN NOW HAS A CLEAR UNDERSTANDING OF RISKS ASSOCIATED WITH STENT OVERSIZING. NOTE: AN ATTEMPT WAS MADE TO OBTAIN THE PT INFO (BIRTH DATE AND WEIGHT), HOWEVER, THE FACILITY WOULD NOT RELEASE THE INFO.

    Description of Event or Problem · 1

    THE STENT WAS PLACED IN A HIGHLY CALCIFIED POPLITEAL ARTERY. THE PHYSICIAN RECOGNIZED THAT THE VESSEL WAS ONLY 4MM IN DIAMETER, BUT DID NOT HAVE A 4MM STENT SIZE. BECAUSE IT WAS A LIMB SALVAGE CASE, HE DECIDED TO USE A 5MM STENT KNOWING THE POTENTIAL RISKS OF OVERSIZING THE STENT. A 4MM BALLOON WAS USED FOR PRE-DILATION. THE STENT WAS DEPLOYED BY THE PHYSICIAN WITHOUT NOTICEABLE INCIDENT. AFTER THE STENT WAS PLACED, THE PHYSICIAN BECAME AWARE THAT THE TIP HAD DETACHED AND WAS IN THE POPLITEAL ARTERY. THE PHYSICIAN RETRIEVED THE TIP USING A SNARE DEVICE. THERE WAS NO EFFECT TO THE PT. THE IMAGES OF THE CASE WERE REVIEWED AND THE VESSEL LOOKED TO BE APPROX 4MM IN DIAMETER. THE STENT ELONGATED DUE TO THE OVERSIZING. THE PHYSICIAN WAS NOT CONCERNED WITH THE FINAL LENGTH OF THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293334 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-05-100-120-6F 01210060

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention