BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3942459 · Received July 17, 2014

    Report

    Report Number
    2024168-2014-04600
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    July 23, 2012
    Report Date
    June 27, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF RESTENOSIS, 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 USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. 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 ON (B)(6) 2010, THE PATIENT UNDERWENT A STENTING PROCEDURE WITH PLACEMENT OF A 2.5 X 15 MM XIENCE V STENT IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND A 3.5 X 23 MM XIENCE V STENT AND A 3.5 X 15 MM XIENCE V STENT IN THE PROXIMAL LAD. ON (B)(6) 2012, RESTENOSIS WAS NOTED IN THE STENT IMPLANTED IN THE MID LAD. A REVASCULARIZATION PROCEDURE WAS PERFORMED AND THE PATIENT CONDITION RESOLVED ON (B)(6) 2012. ON (B)(6) 2013, RESTENOSIS WAS NOTED AGAIN IN THE STENT IMPLANTED IN THE MID LAD. REVASCULARIZATION WAS PERFORMED ON (B)(6) 2013 AND THE PATIENT CONDITION RESOLVED. ON (B)(6) 2014, RESTENOSIS WAS NOTED IN THE STENT IMPLANTED IN THE MID LAD. REVASCULARIZATION WAS PERFORMED AND THE PATIENT CONDITION RESOLVED ON (B)(6) 2014. ON (B)(6) 2014, RESTENOSIS WAS NOTED IN THE STENT IMPLANTED IN THE MID LAD AND A REVASCULARIZATION PROCEDURE WAS PERFORMED. THE PATIENT CONDITION RESOLVED ON (B)(6) 2014. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418510 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0032341

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R STENT: XIENCE V (3.5X23, 3.5X15)| STENT: XIENCE V (3.5X23, 3.5X15)| STENT: XIENCE V (3.5X23, 3.5X15)