BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3250670 · Received July 26, 2013

    Report

    Report Number
    2024168-2013-04715
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    January 13, 2013
    Report Date
    July 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ESTIMATED DATE OF OCCURRENCE. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECT OF HYPERSENSITIVITY/ALLERGIC REACTION IS LISTED IN THE XIENCE V / XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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 PRESENTED TO THE PHYSICIAN AND COMPLAINED OF ITCHING ALL OVER THE BODY. IT IS UNKNOWN WHEN THE ITCHING BEGAN. THE PHYSICIAN REPORTED THIS AS AN ALLERGIC REACTION AND BELIEVES THE ITCHING MAY BE RELATED TO THE XIENCE STENT. THE UNKNOWN XIENCE STENT IS BELIEVED TO HAVE BEEN IMPLANTED IN (B)(6) CENTER, ON (B)(6) 2013. IT IS UNKNOWN IF ANY TREATMENT WAS PROVIDED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350368 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R