BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2241085 · Received August 17, 2011

    Report

    Report Number
    3005325609-2011-00014
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    April 1, 2011
    Report Date
    July 22, 2011
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K093893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO PRIOR REPORTED ADVERSE EVENTS OR DEVICE ISSUES FOR THIS PT. THE STENT FRACTURE WAS LIKELY THE RESULT OF THE INITIAL ELONGATION OF THE STENT AT IMPLANT. THE ELONGATION EVENT WAS A RESULT OF IMPROPER DEPLOYMENT TECHNIQUE. THE PHYSICIAN HAS BEEN RETRAINED. THIS EVENT OCCURRED IN A (B)(4). THE SUPERA DEVICE HOLDS THE CE MARK FOR THE INDICATION OF PERIPHERAL VASCULAR USE. THIS IS ONE OF THREE STENT FRACTURE REPORTED IN THE HISTORY (SINCE 2007) OF THE SUPERA STENT. THE TWO OTHER STENT FRACTURES ALSO OCCURRED IN STENTS THAT WERE EXTREMELY ELONGATED. THE MFR IS WAITING ON ADDITIONAL INFO REGARDING THIS EVENT. AN MDR SUPPLEMENT WILL BE PROVIDED IF NEW RELEVANT INFO IS RECEIVED.

    Description of Event or Problem · 1

    A STENT FRACTURE WAS OBSERVED DURING THE PT'S 12-MONTH F/U VISIT. THE PT WAS ENROLLED IN THE (B)(4). THE STENT WAS IMPLANTED IN THE SFA AND HAD BEEN ELONGATED APPROXIMATELY 106% AT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. SE-05-100-120-G3 01006037

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention