BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2993464 · Received March 7, 2013

    Report

    Report Number
    2024168-2013-01338
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    January 20, 2013
    Report Date
    February 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 WERE NO REPORTED PRODUCT DEFICIENCIES. ANGINA AND THROMBOSIS 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. THE XIENCE XPEDITION 2.5 X 28 MM DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED WITH A ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) AND A XIENCE XPEDITION 2.5 X 28 MM STENT WAS IMPLANTED IN A POSTERIOR LATERAL ARTERY AND A XIENCE XPEDITION 3.0 X 23 MM STENT WAS IMPLANTED IN A PROXIMAL, RIGHT CORONARY ARTERY (PRCA) WITH RIGHT FEMORAL ACCESS WITHOUT DIFFICULTY. THE FOLLOWING DAY, ON (B)(6) 2013, THE PATIENT EXPERIENCED CHEST PAINS (ANGINA) AND THERE WAS A ST-ELEVATION SEEN ON THE ELECTROCARDIOGRAM (EKG). AN ANGIOGRAM WAS DONE WITH FINDINGS OF A THROMBUS IN THE RCA. THE PATIENT WAS TAKEN BACK TO THE CATHETERIZATION LABORATORY AND A THROMBECTOMY WAS DONE WITH LEFT FEMORAL ACCESS. MULTIPLE PASSES WERE NEEDED TO REMOVE THE THROMBUS. A XIENCE XPEDITION 4.0 X 28 MM STENT AND A XIENCE XPEDITION 4.0 X 23 MM STENT WERE DEPLOYED IN THE PRCA OVERLAPPING THE PREVIOUSLY IMPLANTED XIENCE XPEDITION 3.0 X 23 MM STENT IN THE PRCA. STENOSIS WAS REDUCED FROM 100% TO 0%. A XIENCE XPEDITION 2.25 X 15 MM STENT WAS DEPLOYED OVERLAPPING THE PREVIOUSLY IMPLANTED STENT IN THE POSTERIOR LATERAL ARTERY. STENOSIS REDUCED FROM 70% TO 0%. TIMI 3 FREE FLOW WAS OBTAINED. THE PATIENT IS IN STABLE CONDITION. REPORTEDLY, THE PHYSICIAN STATED HE BELIEVES THE THROMBUS WAS POSSIBLY FROM THE USE OF A GENERIC PLAVIX MEDICATION THAT IS NOT AS EFFECTIVE AS THE BRAND NAME. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98011 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2100441

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention