BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3830844 · Received May 23, 2014

    Report

    Report Number
    2024168-2014-03312
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    March 5, 2014
    Report Date
    May 1, 2014
    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). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PATIENT EFFECT OF DISSECTION IS A KNOWN POTENTIAL PATIENT EFFECT AS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU). 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 PATIENT HAD A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND ANOTHER LESION IN THE PROXIMAL CIRCUMFLEX (LCX) WITH 80% STENOSIS. AFTER PLACING AN UNSPECIFIED GUIDE WIRE, PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED NON-COMPLIANT BALLOON AT HIGH PRESSURE. THE LAD LESION WAS TREATED BY DEPLOYING A 3.5 X 18 MM IMPLANT. THE LESION IN THE PROXIMAL LCX WAS TREATED BY IMPLANTING A 3.5 X 28 MM XIENCE PRIME STENT. HOWEVER, A SMALL RETROGRADE DISSECTION WAS OBSERVED AFTER IMPLANTING THE XIENCE PRIME STENT. ANOTHER XIENCE PRIME STENT WAS IMPLANTED TO TREAT THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307412 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3081641

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention