BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2447550 · Received February 9, 2012

    Report

    Report Number
    3005325609-2012-00002
    Event Type
    Injury
    Date Received
    February 9, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 12, 2012
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K093893
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S BIRTHDATE AND WEIGHT WERE REQUESTED WITH NO RESPONSE FROM THE PHYSICIAN OR THE PHYSICIAN'S OFFICE MANAGER. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE COMPLAINT WAS INVESTIGATED USING THE FACTS REPORTED AND KNOWING THE MECHANICS OF THE SUPERA STENT. THE USE OF THE DEVICE IN THE SUBCLAVIAN ARTERY WITHIN A RE-STENOSED STENT WAS LIKELY THE CAUSE OF THE EVENT. THE DIAMETER OF THE RE-STENOSED STENT WAS SMALLER THAN THE DIAMETER OF THE SUBJECT STENT WHICH COULD LEAD TO THE STENT ELONGATING. THE PHYSICIAN WAS TRAINED AND KNOWS THE INDICATED USE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TREATING A SUBCLAVIAN ARTERY TO CORRECT IN-STENT RESTENOSIS OF ANOTHER MFR'S STENT PLACED MONTHS AGO. THE PHYSICIAN ACCESSED THE GROIN AND BALLOONED THE ARTERY THROUGH THE PREVIOUSLY PLACED STENT WITH AN 8MMX40M BALLOON. AFTER TWO MINUTES, THE PHYSICIAN DEFLATED THE BALLOON, PROPERLY PREPPED THE STENT AND DELIVERY CATHETER AND ADVANCED THE CATHETER INTO THE SUBCLAVIAN ARTERY. WHILE DEPLOYING THE STENT THROUGH THE PREVIOUSLY PLACED STENT, THE PHYSICIAN REALIZED THAT IT WAS ELONGATED. THE PHYSICIAN COMPLETED THE DEPLOYMENT. THE END OF THE STENT HAD LANDED IN THE PT'S AORTA. THE PHYSICIAN INSERTED A 12FR SHEATH AND USED A SNARE DEVICE TO REMOVE THE STENT. ANOTHER MFR'S STENT WAS SUCCESSFULLY PLACED AND THERE WAS NO ADVERSE EFFECT TO THE PT. TWENTY-FOUR HOUR F/U CONFIRMED THAT THE PT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-0-040-120-G3 01131046

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CORDIS GENESIS STENT| 12FR SHEATH| 8MMX40MM BOSTON SCIENTIFIC BALLOON| EV3 SNARE