BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2893029 · Received January 2, 2013

    Report

    Report Number
    2024168-2013-00001
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    November 8, 2012
    Report Date
    December 18, 2012
    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 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 THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MODERATELY TORTUOUS, PROXIMAL RIGHT CORONARY ARTERY THAT IS MILDLY CALCIFIED AND 90% STENOSED. PREDILATATION WAS PERFORMED PRIOR TO STENTING. AFTER DEPLOYMENT OF A 3.0X33 MM XIENCE PRIME STENT IN THE LESION, A DISSECTION WAS OBSERVED AT THE PROXIMAL END OF THE STENT IMPLANT. TWO ADDITIONAL 3.0X18 MM AND 2.75X28 XIENCE V STENTS WERE IMPLANTED TO COVER THE DISSECTION SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1696 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1041441

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention