BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 3140106 · Received May 29, 2013

    Report

    Report Number
    3005325609-2013-00014
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 3, 2013
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K1111766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND ANALYZED. THE STENT HAD BEEN DEPLOYED. BESIDES THE DETACHED TIP, NO OTHER ANOMALIES WERE OBSERVED. MAGNIFICATION SHOWED THAT THE PROXIMAL END OF THE TIP LUMEN SHOWED EVIDENCE OF TENSION FAILURE THAT OCCURRED WHEN THE LUMEN SEPARATED FROM THE DISTAL END OF THE RATCHET STEM. THERE WAS EVIDENCE OF STRETCHING OF THE TIP LUMEN. THE PHYSICIAN DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU) IN THAT HE DID NOT CONFIRM UNDER FLUOROSCOPY THAT THE STENT WAS COMPLETELY RELEASED PRIOR TO PULLING THE CATHETER BACK. LOCKING THE THUMB SLIDE IN THE PROXIMAL POSITION CLOSED THE DELIVERY SYS'S TIP TO THE DISTAL END OF THE OUTER SHEATH TRAPPING THE REMAINING LENGTH OF THE STENT IN THE DELIVERY SYS. AS THE DELIVERY SYS WAS WITHDRAWN PROXIMALLY, THE TIP LUMEN DETACHED DUE TO ELONGATION OF THE STENT OR DUE TO LACK OF CLEARANCE WITHIN THE INTRODUCER SHEATH. THE DETACHED TIP INITIALLY REMAINED ON THE GUIDE WIRE AND RETRIEVAL WAS ATTEMPTED. HOWEVER, THE TIP THEN DETACHED AND TRAVELED INTO THE VASCULATURE WHERE IT WAS SURGICALLY REMOVED. THE CAUSE OF THE EVENT IS DUE TO NOT FOLLOWING THE IFU.

    Description of Event or Problem · 1

    THE PHYSICIAN HAD DIFFICULTY CROSSING OVER TO THE LESIONS SITE AND HE THOUGHT THAT THE INTRODUCER SHEATH MAY HAVE KINKED. DURING THE CATHETER WITHDRAWAL, RESISTANCE WAS ENCOUNTERED AND THE STENT ELONGATED BECAUSE IT HAD NOT BEEN FULLY RELEASED OUT OF THE SHEATH. THE PHYSICIAN THOUGHT THAT HE HAD RELEASED THE STENT AND HE DID NOT USE FLUOROSCOPY TO VIEW IT. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO REMOVE THE TIP WITH A SNARE DEVICE; SURGERY TO REMOVE THE TIP WAS PERFORMED WITHOUT FURTHER INCIDENT. THE EVENT OCCURRED IN ITALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237035 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. SE-05-200-120-6F 02039064

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention