BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1843468 · Received September 22, 2010

    Report

    Report Number
    2024168-2010-01981
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 15, 2010
    Report Date
    August 31, 2010
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED HYPERTENSION AND STENOSIS ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. 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 MFG, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT APPROX NINE MONTHS AFTER THE IMPLANTATION OF THE XIENCE STENT INSIDE THE RESTENOSED NON-ABBOTT STENT IN THE PROXIMAL RIGHT CORONARY ARTERY, THE PATIENT EXPERIENCED A HYPERTENSIVE EPISODE. TWO WEEKS AFTER THE HYPERTENSIVE EPISODE, THE PATIENT UNDERWENT AN ANGIOGRAM AND WAS FOUND TO HAVE IN-STENT RESTENOSIS. THE PT UNDERWENT REVASCULARIZATION OF THE TARGET LESION WITH BALLOON DILATATION ONLY. THE PT'S CONDITION RESOLVED AND THERE WAS NO ADVERSE PATIENT SEQUELA. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY AFTER REVASCULARIZATION. THERE WAS NO ADD'L INFO PROVIDED.

    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 811076J

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R