BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3080329 · Received April 26, 2013

    Report

    Report Number
    2024168-2013-02604
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 24, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. ANGINA, MYOCARDIAL INFARCTION, AND HYPOTENSION ARE LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE 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.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING A PROXIMAL LEFT ANTERIOR DESCENDING ARTERY XIENCE XPEDITION STENTING PROCEDURE, THE PATIENT EXPERIENCED SYNCOPE DUE TO HYPOTENSION AND ANGINA. BLOOD PRESSURE WENT DOWN TO 60/40. MEDICATION AND GELOFUSINE WERE ADMINISTERED FOR THE HEMODYNAMICS, RESOLVING THE NON-SERIOUS EVENT. FENTANYL WAS ADMINISTERED FOR THE ANGINA. ONE HOUR POST PROCEDURE, THE ANGINA RESOLVED. AT 19:39, TROPONIN WAS NOTED TO BE SIGNIFICANTLY ELEVATED. CK-MB WAS ALWAYS WITHIN THE NORMAL LIMIT. THERE WAS NO TREATMENT NOTED FOR THE TROPONIN ELEVATION AND NO INDICATION THAT IT WAS CONSIDERED SERIOUS. THE EVENT WAS NOTED TO BE RESOLVED ON THE DAY OF ONSET AND THE PATIENT WAS DISCHARGED HOME. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. SUBSEQUENT TO THE INITIAL INFORMATION, THE FOLLOWING WAS RECEIVED: ON (B)(6) 2013, DURING THE STENTING PROCEDURE, THE PATIENT EXPERIENCED UNSTABLE ANGINA, WHICH CONTINUED FOR ONE HOUR POST-PROCEDURE. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AND WAS DIAGNOSED WITH A MYOCARDIAL INFARCTION. THE EVENT WAS CLASSIFIED AS SERIOUS AND ON (B)(6) 2013, IT WAS NOTED TO BE RESOLVED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183245 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2070341

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| S DIL CATH: PANTERA 3.0X15, PANTERA LEO 3.75X15