BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2834467 · Received November 15, 2012

    Report

    Report Number
    2024168-2012-07230
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    April 1, 2012
    Report Date
    October 23, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA AND STENOSIS/RESTENOSIS ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS. 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 ON (B)(6) 2008, A XIENCE V STENT WAS IMPLANTED IN A DISTAL, LEFT ANTERIOR DESCENDING ARTERY AND AT A FOLLOW UP VISIT, THE PATIENT STATED THAT IN (B)(6) 2012 HE PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAINS [ANGINA] AND WAS DIAGNOSED WITH 70% IN STENT RESTENOSIS. TROPONIN ENZYME LEVELS AND TWO ELECTROCARDIOGRAMS WERE DONE WITH NO FINDINGS OF A MYOCARDIAL INFARCTION. AN ANGIOPLASTY WAS DONE TO THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY AND THE STENT PLACED IN THE DISTAL LAD. REVASCULARIZATION WAS ACHIEVED. THE PATIENT WAS STARTED ON EFFIENT MEDICATION. THERE WAS NO ADDITIONAL INFORMATION 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 8052842

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R