BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2760792 · Received September 26, 2012

    Report

    Report Number
    2024168-2012-06067
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    May 29, 2012
    Report Date
    September 5, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECT OF HYPERSENSITIVITY (ALLERGIC REACTION) IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT. 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

    THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2012 TO UNDERGO AN ELECTROPHYSIOLOGY PROCEDURE; HOWEVER, DURING THE PROCEDURE SHE HAD A MYOCARDIAL INFARCT (MI) AND WAS SENT TO THE CATH LAB WHERE A 2.5 X 28 MM RX XIENCE V WAS IMPLANTED IN HER MID LEFT ANTERIOR DESCENDING ARTERY. A FEW DAYS LATER THE PATIENT BEGAN EXPERIENCING HIVES AND SORES ALL OVER HER BODY. THE PHYSICIAN HAS RECOMMENDED THE PATIENT BE TESTED FOR METAL ALLERGIES. THERE WAS NO OTHER 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-TEMECULA-CT 1111241

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other