BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1299010 · Received January 29, 2009

    Report

    Report Number
    2024168-2009-00131
    Event Type
    Injury
    Date Received
    January 29, 2009
    Date of Event
    December 12, 2008
    Report Date
    January 7, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS, REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA TRIAL THAT THE INDEX PROCEDURE WAS DONE IN 2007, AND A 3.5 X 18 MM XIENCE V STENT WAS DEPLOYED IN THE MID RIGHT CORONARY ARTERY (RCA) LESION. ANOTHER 3.5 X 18 MM XIENCE V STENT WAS DEPLOYED IN THE PROXIMAL CIRCUMFLEX LESION. IN LATE 2008, THE PT RETURNED WITH CHEST PAIN OR ANGINA EQUIVALENT. CLASSIFICATION OF UNSTABLE ANGINA-BRAUNWALD CLASS I. REVASCULARIZATION WAS DONE WITH ANGIOPLASTY AND STENTING WAS DONE TO TREAT RESTENOSIS OF THE MID RCA. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 70226P2

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R STENT: 3.5 X 18 MM XIENCE V STENT