BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2843029 · Received November 21, 2012

    Report

    Report Number
    2024168-2012-07402
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    May 15, 2012
    Report Date
    October 29, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 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 DE NOVO, MID, LEFT ANTERIOR DESCENDING CORONARY ARTERY AND ON (B)(6) 2012 THE PATIENT EXPERIENCED ANGINA AND WAS ADMITTED TO THE HOSPITAL. A DIAGNOSTIC CORONARY ANGIOGRAPHY WAS DONE WITH FINDINGS OF 100% OCCLUDED MID LAD. AN ELECTIVE LEFT INTERNAL MAMMARY ARTERY (LIMA)- LAD, SAPHENOUS VEIN GRAFT (SVG)-DIAGONAL, SVG-OBTUSE MARGINAL, AND SVG-POSTERIOR DESCENDING CORONARY ARTERY BYPASS SURGERY WAS COMPLETED ON (B)(6) 2012 AND THE SYMPTOMS RESOLVED ON (B)(6) 2012. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012 WITHOUT ANY PATIENT ADVERSE SEQUELA. 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 7112141

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R| S