BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 5529979 · Received March 28, 2016

    Report

    Report Number
    2024168-2016-01999
    Event Type
    Injury
    Date Received
    March 28, 2016
    Date of Event
    April 16, 2015
    Report Date
    May 10, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE ANATOMY. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE XIENCE STENTS WERE IMPLANTED ON (B)(6) 2014: A 4.0X18MM XIENCE V STENT IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA), A 2.25X23MM XIENCE PRIME STENT IN THE SECOND OBTUSE MARGINAL CORONARY ARTERY, AND A 2.25X23MM XIENCE PRIME STENT IN THE DISTAL CIRCUMFLEX CORONARY ARTERY. ON (B)(6) 2015, 95% STENOSIS WAS FOUND IN THE PROXIMAL RCA, PROXIMAL TO THE TARGET LESION. ALTHOUGH, THE IMPLANTED XIENCE V STENT WAS NOTED TO BE PATENT, IT IS UNKNOWN IF THE RESTENOSIS WAS WITHIN 5MM OF THE IMPLANTED INDEX STENT. REVASCULARIZATION WAS PERFORMED, WITH IMPLANTATION OF AN ADDITIONAL UNSPECIFIED STENT. THE EVENT RESOLVED ON (B)(6) 2015. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL REPORT, INFORMATION WAS RECEIVED THAT THE STENOSIS IN THE RCA FOUND ON 04/16/2016 WAS NOT WITHIN 5MM OF THE 4.0X18MM XIENCE V STENT IMPLANTED ON (B)(6) 2014; THEREFORE, THE STENOSIS WAS NOT RELATED TO THE STENT. HOWEVER, THIS EVENT HAS ALREADY BEEN REPORTED, SO IT WILL REMAIN REPORTABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185511 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2062741

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R