BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3884422 · Received June 19, 2014

    Report

    Report Number
    2024168-2014-03937
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    November 9, 2012
    Report Date
    May 28, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PATIENT EFFECT OF ISCHEMIA, AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU), IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH THE USE OF CORONARY STENTS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2012 WAS TO TREAT A PATIENT WITH A SUBACUTE ST ELEVATION MYOCARDIAL INFARCTION (STEMI) CAUSED BY A CORONARY ONE-VESSEL DISEASE IN THE RIGHT CORONARY ARTERY (RCA). THE MID RCA SHOWED A 90% STENOSIS (BUT STILL TIMI III FLOW); THE DISTAL RCA NEAR THE OSTIUM TO THE ACUTE MARGINAL BRANCH (AM) WAS 99% CLOSED WITH ONLY MINIMAL RESIDUAL FLOW. PRE-DILATATION OF THE RCA OSTIUM WAS PERFORMED WITH A 2.5X15MM BALLOON WITH A GOOD RESULT, BUT 50% RESIDUAL STENOSIS. THE 3.5X12MM IMPLANT WAS DEPLOYED AT 14 ATM, REDUCING THE RESIDUAL STENOSIS TO 0%. THE AM WAS PRE-DILATED WITH A 1.5X20MM BALLOON, FOLLOWED BY DEPLOYMENT OF A 2.5X23MM XIENCE STENT (UNKNOWN TYPE) IN THE DISTAL RCA. AS THE FLOW WORSENED DISTALLY OF THE XIENCE, ADDITIONAL DILATATION WAS PERFORMED. THE END RESULT ON THE ANGIOGRAM SHOWED 0% RESIDUAL STENOSIS IN THE DISTAL RCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362020 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE CATH: AL1 GC, JR4-GC