BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1378467 · Received May 8, 2009

    Report

    Report Number
    2024168-2009-00803
    Event Type
    Injury
    Date Received
    May 8, 2009
    Date of Event
    October 21, 2008
    Report Date
    April 13, 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
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/ REQUIRED INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION WAS REPORTED. IT WAS REPORTED VIA A TRIAL THAT IN 2008, THE PT UNDERWENT STENTING OF THE MID RCA, THE RAMUS, AND THE PROXIMAL RCA WITH THREE XIENCE V STENTS, ALL LESIONS WERE PRE-DILATED PRIOR TO STENTING. TWO MONTHS LATER, THE PT WAS ADMITTED TO EMERGENCY WITH COMPLAINTS OF CHEST PAIN ON AND OFF FOR TWO WEEKS. THE PT ALSO EXPERIENCED SOME NAUSEA AND VOMITING. THE BLOOD PRESSURE WAS 250/140 AND THE PT WAS UNABLE TO KEEP ANY MEDICATIONS DOWN. THE PT UNDERWENT DIAGNOSTIC CORONARY ANGIOGRAPHY AND PERCUTANEOUS CORONARY INTERVENTION TO THE RAMUS. NO ADDITIONAL EVENT OR PT 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 8050961

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R