BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS CORONARY STENT SYSTEM

    MDR report key: 1739347 · Received June 25, 2010

    Report

    Report Number
    2024168-2010-01268
    Event Type
    Injury
    Date Received
    June 25, 2010
    Date of Event
    June 3, 2010
    Report Date
    June 3, 2010
    Manufacturer
    ABBOTT VASCULAR CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). RASH/HYPERSENSITIVITY/ALLERGIC REACTION IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT 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. THE OTHER XIENCE V (1009540-23, 0021641) IS BEING REPORTED UNDER THIS SAME MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: ITCHING/RASH ALLERGIC REACTION. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED THAT THE DAY FOLLOWING IMPLANTATION OF TWO XIENCE V STENTS IN THE LEFT ANTERIOR DESCENDING ARTERY, THE PT EXPERIENCED GENERALIZED ITCHING AND RASH. THE PT'S CONDITION RESOLVED THE SAME DAY AFTER HE TOOK BENDARYL AS RECOMMENDED BY HIS PHYSICIAN. THERE WAS NO ADVERSE PT SEQUELA. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR CLONMEL NA 0030441

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention STENT: XIENCE V (1009540-23, 0021641)