BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2944373 · Received February 5, 2013

    Report

    Report Number
    2024168-2013-00651
    Event Type
    Death
    Date Received
    February 5, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: STENT: 2.5 X 12 MM XIENCE XPEDITION. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ISCHEMIA, ARRHYTHMIA, AND DEATH ARE LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE PATIENT EVENTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE IF ANY CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM APPROXIMATELY 3 AM IN THE MORNING WITH COMPLAINTS OF BACK PAIN. AN ECHOCARDIOGRAM (ECG/EKG) WAS PERFORMED BUT SHOWED NO ST ELEVATION CHANGES. ABOUT 10 AM THE PATIENT WAS EMERGENTLY TRANSFERRED TO THE CATH LAB IN PAIN AND WITH SEVERE DISCOMFORT. IT WAS NOTED THAT THE PATIENT WAS IN DISTRESS PRIOR TO THE PROCEDURE AND CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED. THE ANGIOGRAM SHOWED THE PATIENT HAD DISEASED LEFT MAIN, CIRCUMFLEX, AND LEFT ANTERIOR DESCENDING (LAD) ARTERY (TRIFUCATION), AND 2 LESIONS IN THE RIGHT CORONARY ARTERY (RCA). AFTER GAINING ACCESS THE PATIENT NEEDED ADDITIONAL CARDIOPULMONARY RESUSCITATION (CPR). AT SOME POINT DURING THE PROCEDURE THE PATIENT HAD ASYSTOLE AND WAS GIVEN A TEMPORARY PACEMAKER AND A BALLOON PUMP WAS USED. THE PROXIMAL TO MID LAD WAS TREATED WITH THE 2.5 X 38 MM XIENCE XPEDITION STENT. THE PATIENT WAS NOT RESPONDING AND THE HEART RATE REMAINED DEPRESSED. A 2.5 X 12 MM XIENCE XPEDITION STENT WAS PLACED IN THE LAD EXTENDING TO THE LEFT MAIN; THERE WAS NO FLOW RESPONSE. THE 2.5 X 12 MM RX TREK BALLOON DILATATION CATHETER (BDC) WAS USED IN THE CIRCUMFLEX FOLLOWED BY CHEST COMPRESSIONS (CPR). AFTER APPROXIMATELY 1 HOUR OF PROCEDURE TIME THE PHYSICIAN REPORTED THE PATIENT HAD DIED. CAUSE OF DEATH HAS NOT BEEN PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47608 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2082941

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death