BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3211778 · Received July 8, 2013

    Report

    Report Number
    2024168-2013-04270
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 13, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE ANATOMY. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF DISSECTION IS LISTED IN THE XIENCE V 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A FEMORAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE MODERATELY CALCIFIED, MODERATELY TORTUOUS, DE NOVO MID RIGHT CORONARY ARTERY A 1.5 X 8 MM NC BALLOON WAS USED FOR PRE-DILATATION. A 3.0 X 23 MM XIENCE V STENT WAS IMPLANTED, HOWEVER, A DISTAL EDGE DISSECTION WAS NOTED. A 3.0 X 12 MM XIENCE V STENT WAS USED TO TREAT THE DISSECTION WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309844 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2120941

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention