BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3230358 · Received July 16, 2013

    Report

    Report Number
    2024168-2013-04478
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 20, 2013
    Report Date
    July 2, 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). IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DISSECTION, AS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE IS A KNOWN PATIENT EFFECT ASSOCIATED WITH 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 THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MILDLY TORTUOUS AND CALCIFIED MID RIGHT CORONARY ARTERY (RCA) THAT IS 90% STENOSED. PREDILATATION WAS PERFORMED PRIOR TO STENTING. AFTER DEPLOYMENT OF A 3.0X23 MM XIENCE PRIME STENT IN THE LESION, A DISTAL EDGE DISSECTION OCCURRED. A 3.0X12 XIENCE PRIME STENT WAS IMPLANTED TO COVER THE DISSECTION SUCCESSFULLY AFTER POST DILATATION. THERE WAS NO RESISTANCE DURING ADVANCEMENT OR REMOVAL OF THE DEVICE. 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
    327861 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2103041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention