BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2031937 · Received March 28, 2011

    Report

    Report Number
    2024168-2011-02071
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. DATE OF EVENT HAS BEEN ESTIMATED THERE WAS NO REPORTED PRODUCT DEFICIENCY. SHOCK, EMBOLISM, AND HYPERSENSITIVITY/ALLERGIC REACTION ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY. 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

    REPORTEDLY AFTER THE IMPLANTATION OF TWO XIENCE V STENTS (3.5X15, 2.5X23) IN THE RIGHT CORONARY ARTERY WHICH WERE OVERLAPPING, AND WITHDRAWAL OF THE BALLOON, THE PATIENT BEGAN EXPERIENCING ANAPHYLAXIS WHICH WAS TREATED WITH EPINEPHRINE AND PLACEMENT OF A BALLOON PUMP. THE PATIENT ALSO DEVELOPED A RASH WHICH THE PHYSICIAN THOUGHT POSSIBLY COULD BE AN ALLERGIC REACTION TO THE XIENCE V STENTS. THE PHYSICIAN FELT THE PATIENT'S ANAPHYLAXIS COULD HAVE BEEN DUE TO AN UNCONFIRMED EMBOLISM OR AN ALLERGIC REACTION SINCE THE PATIENT DEVELOPED A RASH. THE PATIENT WAS STABLE BUT WAS SENT FOR A CORONARY ARTERY BYPASS GRAFT BECAUSE THEY HAD MULTIPLE VESSEL DISEASE. THE PATIENT IS DOING FINE NOW. NO ADDITIONAL EVENT OR PATIENT 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 70 YR Required Intervention| S STENT: 3.5X15 XIENCE V