BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1935982 · Received December 22, 2010

    Report

    Report Number
    2024168-2010-02861
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    June 30, 2010
    Report Date
    November 29, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    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. THE REPORTED PATIENT EFFECTS OF FATIGUE AND HYPERSENSITIVITY (ALLERGIC REACTION), AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU), 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 WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING AND THE TREATMENT APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. THE 3.5 X 23 MM XIENCE V ((B)(4)), IS BEING FILED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    THE PATIENT CALLED TO REPORT THAT SHE IS HAVING A POTENTIAL ALLERGIC REACTION (RASH) BEGINNING END OF JUNE, EARLY JULY TO THE TWO XIENCE V STENTS THAT WERE DEPLOYED ON (B)(6) 2010, IN THE LEFT ANTERIOR DESCENDING ARTERY(LAD) AND THE RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS SENT BY HER PHYSICIAN TO SEE A DERMATOLOGIST WHO DETERMINED THE RASH TO BE INSECT BITES AND PRESCRIBED AN ANTIBIOTIC CREAM FOR TREATMENT OF THE RASH; HOWEVER, THE SYMPTOMS CLEARED UP INITIALLY AND THEN RETURNED. SHE ALSO COMPLAINED OF FATIGUE SINCE THE DATE OF IMPLANT. THE PATIENT IS CURRENTLY TAKING PLAVIX AND ASPIRIN, AND STATES THAT SHE IS ALLERGIC TO MORE THAN A FEW MEDICATIONS. NO ADDITIONAL INFORMATION WAS 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 0010441

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention STENT: 3.5 X 23 MM XIENCE V ((B)(4))