BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3250453 · Received July 26, 2013

    Report

    Report Number
    2024168-2013-04703
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    June 10, 2013
    Report Date
    July 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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 ANGINA AND STENOSIS/RESTENOSIS ARE LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS 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 ON (B)(6) 2012, THE PATIENT UNDERWENT A STENTING PROCEDURE WITH PLACEMENT OF A 3.5 X 23 MM XIENCE PRIME IN THE DISTAL CIRCUMFLEX (CX) ARTERY AND A 3.0 X 28 MM XIENCE PRIME IN THE MID RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2013, THE PATIENT EXPERIENCED AN EPISODE OF ANGINA. ELECTROCARDIOGRAM AND CARDIAC ENZYMES WERE WITHIN NORMAL LIMITS. ANGIOGRAPHY PERFORMED ON (B)(6) 2013 NOTED THE STENTS IMPLANTED IN THE CX AND RCA WERE PATENT; HOWEVER, RESTENOSIS WAS NOTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, THE SITE OF AN UNSPECIFIED XIENCE PRIME STENT PREVIOUSLY IMPLANTED IN 2007. RESTENOSIS IN THE LAD WAS TREATED WITH IMPLANTATION OF 2 XIENCE PRIME STENTS. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2013. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351050 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R