BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1954513 · Received January 10, 2011

    Report

    Report Number
    2024168-2011-00178
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    March 26, 2010
    Report Date
    December 16, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF, HYPERSENSITIVITY (ALLERGIC REACTION) AND PAIN, AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE (IFU), ARE KNOWN ADVERSE EVENTS. IN THIS CASE, THE PATIENT EXPERIENCED HYPERSENSITIVITY (ALLERGIC REACTION) AND PAIN POST PROCEDURE WHICH WAS TREATED WITH MEDICATIONS. 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, LABELING AND DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PROMUS STENT WAS IMPLANTED IN AN UNSPECIFIED VESSEL ON (B)(6), 2010. REPORTEDLY, ONE WEEK AFTER STENT IMPLANT, THE PATIENT DEVELOPED A RASH DIAGNOSED BY A DERMATOLOGIST AS ECZEMA, NECK TO TOES. REPORTEDLY, THE PATIENT TAKES MULTIPLE SHOWERS FOR THE PAIN. PATIENT HAS BEEN ON ORAL STEROIDS THREE TIMES, NUMEROUS TOPICALS, INJECTIONS UNDER THE SKIN, AND STEROIDS. STEROIDS SEEM TO EXASERBATE THE RASH. THE PATIENT HAS BEEN REFERRED TO AN ALLERGIST. A REACTION TO PLAVIX HAS BEEN RULED OUT. FAMILY HAS REQUESTED THAT THE PATIENT BE TESTED FOR NICKLE ALLERGY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 9061661

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention