BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2100956 · Received May 24, 2011

    Report

    Report Number
    2024168-2011-03646
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. HYPERSENSITIVITY/ALLERGIC REACTION IS A KNOWN ADVERSE EVENT LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT 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 ON (B)(6) 2011, A XIENCE V STENT WAS IMPLANTED IN AN UNSPECIFIED VESSEL. ON (B)(6) 2011, THE PATIENT COMPLAINED OF A POSSIBLE COBALT CHROMIUM AND NICKEL ALLERGY DURING AN OFFICE VISIT. THE SPECIFIC SYMPTOMS WERE NOT PROVIDED. THE PATIENT READ THE XIENCE V PAMPHLET AND BELIEVES THAT THE UNSPECIFIED SYMPTOMS ARE RELATED TO THE STENT AND WANTS THE STENT EXPLANTED. THE PHYSICIAN STATED THAT DUE TO THE LENGTH OF TIME FROM STENT IMPLANT TO ONSET OF SYMPTOMS, THE REACTION IS PROBABLY NOT RELATED TO THE STENT. NO TREATMENT WAS PROVIDED; HOWEVER, AN ALLERGY PATCH TEST IS PLANNED. THOUGH REQUESTED, 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-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other