BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2800462 · Received October 22, 2012

    Report

    Report Number
    2024168-2012-06667
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    March 29, 2011
    Report Date
    September 27, 2012
    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 PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ISCHEMIA AND RESTENOSIS, AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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. THE OTHER XIENCE V STENT, REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 6 MONTHS POST IMPLANTATION OF 3 XIENCE V STENTS IN THE RIGHT CORONARY ARTERY (RCA), THE PATIENT RETURNED FOR A 240-DAY FOLLOW-UP VISIT. THE PATIENT WAS NOT EXPERIENCING ANGINA, BUT WAS POSITIVE FOR SILENT ISCHEMIA. PER ANGIOGRAPHY, THE PROXIMAL RCA WAS FOUND TO HAVE 0% STENOSIS, THE MID RCA 75% STENOSIS AND THE DISTAL 90% STENOSIS. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED TO THE TARGET VESSEL / TARGET LESION, THE TARGET VESSEL AND A NON-TARGET VESSEL, RESOLVING THE EVENT. THERE WAS NO ADVERSE SEQUELA REPORTED AND NO ADDITIONAL INFORMATION PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R STENT: XIENCE 3.0X28MM