BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S5/S5I SERIES INTRAVASCULAR IMAGING SYSTEM

    MDR report key: 3591486 · Received January 10, 2014

    Report

    Report Number
    2939520-2014-00005
    Event Type
    Injury
    Date Received
    January 10, 2014
    Date of Event
    June 29, 2013
    Report Date
    September 7, 2013
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    IYO
    PMA / PMN Number
    K123898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAKAGE CURRENT IS NOT A POTENTIAL CONCERN SINCE THE WIRE WAS NOT CONNECTED TO THE S5X SYSTEM AT THE TIME OF THE REPORTED SHOCKS. A REVIEW OF SERVICE RECORDS FOR S5X SYSTEM INDICATE THAT THE UNIT WAS SATISFACTORILY SERVICED ON (B)(4) 2013 ACCORDING TO THE RECOMMENDED PREVENTIVE MAINTENANCE SCHEDULE DURING WHICH NO ISSUES WERE IDENTIFIED. SUBSEQUENT TO THIS EVENT, NO OTHER EVENTS HAVE BEEN REPORTED WITH THIS S5X SYSTEM RELATED TO THIS ISSUE. AN ADDITIONAL REVIEW OF ALL S5X SYSTEM COMPLAINTS DO NOT SHOW A SIMILAR INSTANCE AS REPORTED HERE. AS A PRECAUTION, THE SYSTEM HAS BEEN RETURNED FOR CONFIRMATION THAT IT CONTINUES TO MEET SPECIFICATION AS HAS BEEN INDICATED BY SERVICE RECORDS AND PERFORMANCE. NO ISSUES WITH THE DEVICE WERE DETECTED THAT COULD HAVE CONTRIBUTED TO THE REPORTED INAPPROPRIATE SHOCKS. AN UNRELATED OUT OF SPECIFICATION CONDITION WAS REPORTED THAT EXCEEDS EMISSIONS CRITERIA BY (B)(4). THE PROXIMITY OF THE ORIGIN OF THIS SIGNAL IS NOT LIKELY TO HAVE BEEN CLOSE ENOUGH TO THE ICD TO INTERFERE WITH ITS PERFORMANCE GIVEN THE ICD WAS IMPLANTED IN THE PATIENT. PRIMEWIRE PRESTIGE PLUS GUIDE WIRE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS PRESENTED TO EMERGENCY DELIVERY WITH 2-HOURS OF CHEST PAIN AND ST-SEGMENT ELEVATIONS IN V1-V3. THE PATIENT WAS TAKEN TO CARDIAC CATHETERIZATION LAB. NO THROMBOTIC LESIONS WERE IDENTIFIED, BUT THE LIMA WAS NO LONGER PATENT. HOWEVER THERE WAS A CHRONIC APPEARING 70% LESION IN THE MIN LAD. FRACTIONAL FLOW RESERVE (FFR) WAS PERFORMED WITH VOLCANO PRESTIGE PLUS PRESSURE GUIDEWIRE. THE FFR ACROSS THE LESION WITH MAXIMAL HYPEREMIA USING ADENOSINE INFUSION WAS 0.77. THE PRESTIGE PLUS PRESSURE GUIDEWIRE WAS DISCONNECTED FROM THE POWER SOURCE. A 4.04 X 15 RESOLUTE BARE METAL STENT WAS PASSED OVER THE FFR WIRE, BUT COULD NOT CROSS THE LESION. A SECOND COUGAR LS0.014 GUIDEWIRE WAS ADVANCED ACROSS THE LESION INTO THE DISTAL LAD. AT THIS POINT, TWO WIRES WERE IN THE DISTAL SEGMENT OF THE LEFT ANTERIOR DESCENDING ARTERY. THE PATIENT THEN RECEIVED 2 SHOCKS FROM HIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE. THE PATIENT WAS IN SINUS RHYTHM AT THE TIME; THEREFORE IT WAS FELT THAT THE SHOCKS MAY HAVE BEEN INAPPROPRIATE. A MAGNET WAS PLACED ON THE ICD DEVICE UNTIL IT COULD BE INTERROGATED. THE 4.0 X 15 RESOLUTE STENT CROSSED THE LESION AND WAS INFLATED TO 14 ATM WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS TRANSFERRED TO CARDIAC CARE UNIT (CCU) IN STABLE CONDITION. VOLCANO CORPORATION WAS FURTHER NOTIFIED THE PATIENT DID NOT HAVE ADDITIONAL INAPPROPRIATE SHOCKS DURING THIS HOSPITALIZATION AND WAS DISCHARGED ON POST OPERATION DAY 1. IN ADDITION, THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2013 AND WAS REPORTED TO BE DOING WELL WITH NO ADDITIONAL SHOCKS, EITHER APPROPRIATE OR INAPPROPRIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20757 S5/S5I SERIES INTRAVASCULAR IMAGING SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRAS IYO VOLCANO CORPORATION 807300001

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention IMPLANT:| 4.0X15 RESOLUTE STENT (MEDTRONIC)| ICD: MODEL GUIDANT T177 VR VITALITY 2| IMPLANT:| COUGAR LS0.014 WIRE (MEDTRONIC)| RV LEAD: GUIDANT 0181 ENDOTAK RELIANCE S.