BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3903416 · Received June 30, 2014

    Report

    Report Number
    2024168-2014-04236
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    October 29, 2013
    Report Date
    June 24, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2013: CK=4134 U/L, NORMAL UPPER LIMIT 190. ON (B)(6) 2013: CK-MB=226 U/L, NORMAL UPPER LIMIT 25. ON (B)(6) 2013: TROPONIN I=50 NG/ML, UPPER REFERENCE LIMIT 0.78. CONCOMITANT MEDICAL PRODUCTS: STENT: XIENCE PRIME 3.0X28MM. OTHER: ASPIRIN, CLOPIDOGREL. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF MYOCARDIAL INFARCTION, AS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU), IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH THE USE OF CORONARY STENTS. IN THIS CASE, 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) 2013, THE PATIENT UNDERWENT A STENTING PROCEDURE WITH PLACEMENT OF A 2.75 X 38 MM XIENCE PRIME STENT AND A 3.0 X 28 MM XIENCE PRIME STENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. ONE DAY POST PROCEDURE, THE PATIENT'S CARDIAC ENZYMES WERE ELEVATED AND A MYOCARDIAL INFARCTION WAS DIAGNOSED. MEDICATION WAS ADMINISTERED. THE PATIENT CONDITION RESOLVED ON (B)(6) 2013 AND THE PATIENT WAS DISCHARGED ON (B)(6) 2013. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379276 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3021241

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R| S SEE H10 FOR CONCOMITANT MEDICAL DEVICES