BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2887198 · Received December 20, 2012

    Report

    Report Number
    3005325609-2012-00038
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND ANALYZED. THE PHYSICIAN ACKNOWLEDGED THAT A PORTION OF THE STENT WAS DEPLOYED WITH THE INTRODUCER RESULTING IN STENT ENTRAPMENT IN THE INTRODUCER AND THE TIP OVERMOLD DETACHMENT WHEN THE THUMB SLIDE WAS ADVANCED FOR CONTINUED STENT DEPLOYMENT. 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.

    Description of Event or Problem · 1

    FOLLOWING SUCCESSFUL DEPLOYMENT OF THE SUPERA STENT IN THE POPLITEAL/DISTAL SFA, A SECOND SUPERA STENT WAS SELECTED. DURING PLACEMENT, THE PROXIMAL PORTION OF THE STENT APPEARED TO REMAIN CONSTRAINED WITHIN THE 6FR BALKIN SHEATH. WHEN THE THUMB SLIDE WAS ADVANCED, THE CATHETER TIP DETACHED. THE ENTIRE STENT ASSEMBLY, INCLUDING THE DETACHED CATHETER TIP WAS RETRIEVED BY ADVANCING THE SHEATH OVER THE EXISTING GUIDEWIRE. THE DEPLOYED PORTION OF THE STENT CAPTURED THE TIP AND WAS REMOVED OVER THE WIRE BY ADVANCING THE EXISTING SHEATH. WIRE ACCESS WAS MAINTAINED THROUGHOUT AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS OR EFFECTS TO THE PATIENT. THE PHYSICIAN IS AWARE OF THE CAUSE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-05-120-120-6F 01286061

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention SHEATH: BALKIN 6FR