BEUDAMED
    FDA Adverse Event Other Summary report: N

    INNOVA 3100

    MDR report key: 2103792 · Received May 19, 2011

    Report

    Report Number
    9611343-2011-00040
    Event Type
    Other
    Date Received
    May 19, 2011
    Date of Event
    January 20, 2011
    Report Date
    May 19, 2011
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    MQB
    PMA / PMN Number
    K042053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS A PART OF GE HEALTHCARE'S INVESTIGATION, LOG FILES AND DICOM DATA WERE COLLECTED, AND THE MEASUREMENTS WERE REPRODUCED. THE DEVICE WAS FOUND TO OPERATE ACCORDING TO SPECIFICATIONS. THE CLINICAL JUDGMENT ERROR WAS DETERMINED TO BE IN THE ASSESSMENT OF THE TOTAL VESSEL AND THE APPROPRIATE SECTION OF THE VESSEL TO ESTABLISH AS THE "NORMAL" SECTION OR "REFERENCE DIAMETER." THE CIRCUMFLEX VESSEL WAS NOT MEASURED DISTAL ENOUGH FROM THE STENOSIS TO GET AN ACCURATE MEASUREMENT OF THE "REFERENCE DIAMETER." THE DIAMETER OF THE STENT HAD BEEN CHOSEN BASED ON THE VESSEL DIAMETER AT A PLACE THAT WAS SUFFERING FROM PLAQUE BURDEN. THE PLAQUE BURDEN AT THIS AREA WAS NOT CLEARLY VISIBLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS BEING IMAGED DURING A CARDIAC CATHETERIZATION PROCEDURE FOR A STENOSIS. THE TECHNOLOGIST MEASURED A "NORMAL" SECTION OF THE VESSEL OR "REFERENCE DIAMETER" WITH AN INNOVA 3100 AND DETERMINED IT TO BE 2.4MM +/- 0.13MM. A 2.5MM STENT WAS DEPLOYED AND AFTER POST DILATION OF THE STENOSIS, THE STENT MOVED DOWN THE VESSEL TO THE BIFURCATION OF THE CIRCUMFLEX VESSEL. THE CUSTOMER THEN PERFORMED AN INTRAVASCULAR ULTRASOUND AND MEASURED THE VESSEL AT 4.0MM. THE USER INSERTED AND DEPLOYED AN ADDITIONAL 3.5MM STENT, WHICH COVERED THE STENOSIS AND ALSO WAS THE "EXTENSION" OF THE FIRST STENT WHICH HAD MOVED DOWN (STENT-IN-STENT TECHNIQUE). FOLLOWING THE PROCEDURE THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 3100 FLUOROSCOPIC X-RAY SYSTEM MQB GE MEDICAL SYSTEMS 2335139-2

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention