BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1914521 · Received December 3, 2010

    Report

    Report Number
    2024168-2010-02594
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    June 23, 2010
    Report Date
    November 10, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. PATIENT ID: (B)(6). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THROMBOSIS, ISCHEMIA, HYPOTENSION, AND ENZYME ELEVATION ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. 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 VIA TRIAL THAT AFTER XIENCE V STENT IMPLANTATION (3.0X28MM) IN THE DISTAL RIGHT CORONARY ARTERY (DRCA), SLOW FLOW WAS NOTED AND TREATED WITH NITROPRO RESULTING IN A DROP IN BLOOD PRESSURE. VASOPRESSORS WERE ADMINISTERED. ADDITIONALLY, THROMBUS WAS NOTED INSIDE THE STENT AND WAS TREATED WITH AN ASPIRATION CATHETER. A 3.5X28MM XIENCE V STENT WAS THEN IMPLANTED IN THE PROXIMAL RCA (PRCA) FOLLOWED BY ADDITIONAL ASPIRATION TO THE DRCA STENT. THE PATIENT REMAINED HOSPITALIZED DUE TO ELEVATED ENZYME VALUES. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-CLONMEL 0030841

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R TAZUNA 3.0X15MMXIENCE V STENT DELIVERY SYSTEM