BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3895378 · Received June 25, 2014

    Report

    Report Number
    2024168-2014-04110
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    January 17, 2014
    Report Date
    June 5, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INTIMAL DISSECTION IS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE (IFU) AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: STENT: XIENCE PRIME (4.0X15MM, 3.5X23MM, 2.75X18MM, 3.0X28MM); OTHER: ASPIRIN, CLOPIDOGREL. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT WAS HOSPITALIZED DUE TO UNSTABLE ANGINA. ON (B)(6) 2014, TROPONIN I REMAINED ELEVATED. ON (B)(6) 2014 DURING A DISTAL RIGHT CORONARY ARTERY (RCA) STENTING PROCEDURE, A DISSECTION WAS NOTED IN THE MID RCA. A 3.0X28MM XIENCE PRIME STENT WAS IMPLANTED, SUCCESSFULLY TREATING THE DISSECTION. DURING THIS PROCEDURE, INCLUDING THE STENT IN THE MID RCA, 6 XIENCE PRIME STENTS WERE IMPLANTED. ON 01/18/2014, TROPONIN I WAS NOTED TO BE ELEVATED AND THE PATIENT WAS DISCHARGED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370269 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2051441

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention