BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3122753 · Received May 21, 2013

    Report

    Report Number
    2024168-2013-03205
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 26, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF HYPERSENSITIVITY (ALLERGIC REACTION) AND RASH, AS LISTED IN THE XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE, ARE LISTED AS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ANGIOGRAPHY ON (B)(6) 2013 IN WHICH A 95% LEFT ANTERIOR DESCENDING ARTERY OCCLUSION WAS TREATED WITH IMPLANTATION OF A 4.0X28 RX XIENCE XPEDITION STENT. THE PATIENT RECEIVED ANGIOMAX AND BRYLINTA DURING THE PROCEDURE. THE PATIENT STAYED IN THE HOSPITAL OVERNIGHT AND THE FOLLOWING MORNING ON (B)(6) 2013, THE NURSE OBSERVED THAT THE PATIENT'S FACE WAS RED, AND NECK AND UPPER CHEST EXHIBITED REDNESS RESEMBLING A SUNBURN. THE PATIENT WAS DISCHARGED THAT AFTERNOON. THE CARDIOLOGIST BELIEVED THAT THE CONDITION MAY BE DUE TO BRYLINTA AND THE PATIENT WAS SWITCHED TO EFFIENT. THE PATIENT WAS GIVEN A PRESCRIPTION FOR MEDROL AND BENADRYL PRN. THE PATIENT HAS BEEN REFERRED TO AN ALLERGIST FOR SKIN TESTING. REPORTEDLY, THE CONDITION IS IMPROVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224913 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2112341

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention