BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3150783 · Received June 6, 2013

    Report

    Report Number
    2024168-2013-03548
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    November 14, 2012
    Report Date
    May 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF THROMBOSIS 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT ESTIMATED AS (B)(6) 2012, BASED ON DATE OF PUBLICATION. DATE OF IMPLANT ESTIMATED AS (B)(6) 2012, BASED ON DATE OF PUBLICATION. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED DURING LITERATURE REVIEW OF THE ARTICLE: CHRONIC TOTAL OCCLUSIONS: SUCCESSFUL RECANALIZATION OF VERY OLD LESIONS. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TOTALLY OCCLUDED RIGHT CORONARY ARTERY. THE MIRACLEBROS III GUIDE WIRE WAS ADVANCED, BUT COULD NOT FULLY CROSS THE TOTAL OCCLUSION. A FIELDER XT GUIDE WIRE WAS USED TO CROSS THE LESION SUCCESSFULLY AND MULTIPLE XIENCE STENTS WERE IMPLANTED TO TREAT THE LESION. FOLLOWING THIS, THE EXPORT ASPIRATION CATHETER WAS USED TO REMOVE ANY THROMBUS. SUBSEQUENTLY, 10 MCG OF INTRACORONARY NITROGLYCERIN WAS ADMINISTERED. AT 3-MONTH FOLLOW UP, THE PATIENT HAD NO ANGINA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251074 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention GUIDE WIRE: FIELDER XT GUIDE CATH: FINECROSS