BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 3187265 · Received June 21, 2013

    Report

    Report Number
    3005325609-2013-00018
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    February 22, 2013
    Report Date
    May 24, 2013
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K111766
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED. THIS EVENT WAS LEARNED OF THROUGH THE ATTACHED USER FACILITY MEDWATCH REPORT, (B)(4), SENT TO THE COMPANY BY FDA. THE MEDWATCH REPORT FROM THE USER FACILITY INDICATED TWO DEVICES AND IT HAS NOT BEEN DETERMINED WHICH DEVICE WAS INVOLVED IN THE EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE, HOWEVER, THE INFORMATION WAS NOT RECEIVED. FURTHER ATTEMPTS ARE BEING MADE TO OBTAIN THE INFORMATION (I.E., PATIENT INFORMATION, DEVICE MODEL AND LOT NUMBER, DEVICE LOCATION AND PATIENT FOLLOW-UP STATUS). AN MDR SUPPLEMENT WILL BE PROVIDED UPON RECEIVING THE REQUESTED INFORMATION.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PERFORMING AN AORTOGRAM WITH RIGHT LOWER EXTREMITY RUNOFF WITH POSSIBLE ANGIOPLASTY AND OR STENT PLACEMENT. THE PHYSICIAN HAD DEPLOYED SEVERAL STENTS AND WAS IN THE PROCESS OF PLACING ANOTHER STENT WHEN THE PROXIMAL PORTION OF THE STENT DEPLOYED IN THE DISTAL END OF THE SHEATH. THE PHYSICIAN WAS UNABLE TO DEPLOY THE STENT FROM THE SHEATH AND AS A RESULT HE HAD TO TAKE THE PATIENT TO SURGERY FOR REMOVAL OF THE SHEATH. A RIGHT COMMON FEMORAL ENDARTERECTOMY WITH PATCH BOVINE ANGIOPLASTY WAS ALSO PERFORMED TO IMPROVE THE PATIENT'S CIRCULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283525 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention