BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3243462 · Received July 23, 2013

    Report

    Report Number
    2024168-2013-04623
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 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). CONCOMITANT PRODUCTS: GUIDE WIRE: BMW, CHOICE PT; GUIDE CATH: BOSTON SCIENTIFIC RUNWAY 6F HS. (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA, MYOCARDIAL INFARCTION, AND THROMBOSIS, AS LISTED IN THE ELECTRONIC XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE, ARE KNOWN PATIENT EFFECTS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT PRESENTED WITH CHEST PAIN AND WAS FOUND TO HAVE AN ST ELEVATION MYOCARDIAL INFARCTION (STEMI) DUE TO A THROMBOTIC OCCLUSION IN THE MID TO PROXIMAL RIGHT CORONARY ARTERY. ON (B)(6) 2013, A 3.5X28MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH EXCELLENT RESULTS. DUAL ANTIPLATELET THERAPY WAS STARTED AND ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2013, THE PATIENT PRESENTED WITH CHEST PAIN AND AGAIN WAS DIAGNOSED WITH AN STEMI DUE TO THROMBOSIS. THIS TIME, THE THROMBUS WAS SEEN NOT ONLY IN THE RCA, BUT THROUGHOUT THE CORONARY VESSELS. A 2.5X12MM TREK RX BALLOON WAS TAKEN TO THE RCA AND THE VESSEL BALLOONED. A NON-ABBOTT GUIDE CATHETER WAS DEEP SEATED INTO THE PROXIMAL RCA. AN EXTRACTION CATHETER WAS USED TO REMOVE THROMBUS, BUT NO THROMBUS WAS REMOVED. WIRES WERE EXCHANGED. THE 2.5X12MM TREK RX BALLOON WAS RE-ADVANCED INTO THE VESSEL AND AT THAT POINT IT WAS NOTED THAT THE DEVICE WAS IN THE SUB-LUMINAL SPACE. PER THE PHYSICIAN, THE DEEP SEATING OF THE GUIDE CATHETER CAUSED DAMAGE TO THE VESSEL BY CREATING A FALSE LUMEN/DISSECTION. ATTEMPTS WERE MADE TO TREAT THE DISSECTION, BUT THE DEVICES COULD NOT CROSS BEYOND THE DISSECTION. THE PATIENT WAS TAKEN TO SURGERY FOR CORONARY BYPASS GRAFT SURGERY. SURGERY WAS WELL TOLERATED AND DISCHARGE WAS ANTICIPATED FOR (B)(6) 2013. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343825 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2120441

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R| S