BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2930007 · Received January 25, 2013

    Report

    Report Number
    2024168-2013-00397
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECT OF DISSECTION IS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT. 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 DURING A PROCEDURE OF THE MODERATELY TORTUOUS, MODERATELY CALCIFIED, 99% STENOSED MID RIGHT CORONARY ARTERY (RCA), AFTER PREDILATATION WITH A 1.5 X 15 MM BALLOON CATHETER, THE 2.75 X 33 MM XIENCE PRIME WAS IMPLANTED, HOWEVER, A PROXIMAL EDGE DISSECTION WAS NOTED. A 3.0 X 12 MM XIENCE V STENT WAS IMPLANTED TO TREAT THE DISSECTION. 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
    35621 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2062041

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention