BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3080201 · Received April 26, 2013

    Report

    Report Number
    2024168-2013-02600
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. PATIENT EFFECTS OF ANGINA AND THROMBOSIS, AS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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. THE ADDITIONAL XIENCE XPEDITION DEVICE REFERENCED, IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM IN DISTRESS AND POSITIVE FOR AN ACUTE MYOCARDIAL INFARCTION (MI). THE PATIENT WAS PRE-TREATED WITH ANGIOMAX, PLAVIX AND ASPIRIN. AROUND 21:00, THE PATIENT WAS TAKEN TO THE CATHETER LAB WHERE THE MID TO PROXIMAL RIGHT CORONARY ARTERY WAS FOUND TO BE THROMBOSED. THE VESSEL WAS TREATED WITH THROMBECTOMY AND PRE-DILATATION. TWO XIENCE XPEDITION STENTS WERE IMPLANTED WITH GOOD RESULTS AND THE PATIENT WAS TAKEN TO A HOSPITAL ROOM. WITHIN A COUPLE OF HOURS, THE PATIENT REPORTED CHEST PAIN AND WAS TAKEN EMERGENTLY, BACK TO THE CARDIAC CATHETER LAB WHERE THROMBOSIS WAS SEEN IN THE VESSEL AND INSIDE BOTH NEWLY IMPLANTED XIENCE XPEDITION STENT. THE VESSEL WAS ASPIRATED AND A 3.25X12MM XIENCE XPEDITION WAS IMPLANTED PROXIMAL TO THE TWO IMPLANTED STENTS, RESOLVING THE EVENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182714 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3011541

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention STENT: 3.25X15MM XIENCE XPEDITION STENT