BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1705885 · Received May 28, 2010

    Report

    Report Number
    2024168-2010-01080
    Event Type
    Injury
    Date Received
    May 28, 2010
    Date of Event
    May 4, 2010
    Report Date
    May 6, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE STENT REMAINS IN PT. A F/U WILL BE SUBMITTED WITH ANY RELEVANT INFO. THE 4.0 X 12 MM XIENCE V (PART 1009543-12, LOT 8091761), IS BEING FILED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. ADVERSE EVENT: IN-STENT RESTENOSIS/MYOCARDIAL INFARCTION/INTERVENTION. TIME OF ADVERSE EVENT: POST PROCEDURE. IT WAS REPORTED VIA A TRIAL THAT ON (B) (6) 2009, A 4 X 12 MM XIENCE STENT WAS IMPLANTED WITHIN THE SAPHENOUS VEIN GRAFT TO THE LEFT ANTERIOR DESCENDING ARTERY SVG TO LAD. ON (B) (6) 2009, THE PT EXPERIENCED A NON-ST ELEVATION MYOCARDIAL INFARCTION DUE TO RESTENOSIS WITHIN THE XIENCE V STENT. TREATMENT WAS PERFORMED ON (B) (6) 2009 (INDEX PROCEDURE) VIA STENTING OF THE PRE-DILATED RESTENOSED XIENCE V STENT WITHIN THE SAPHENOUS VEIN GRAFT TO THE LEFT ANTERIOR DESCENDING ARTERY WITH TWO XIENCE V STENTS; THE MOST DISTAL STENT IMPLANTED WITHIN THE RESTENOSED STENT. ON (B) (6) 2010, THE PT PRESENTED TO THE ER WITH COMPLAINTS OF INTERMITTENT CHEST PAIN. LABS REVEALED ELEVATED TROPONIN LEVEL AND NON-ST ELEVATED MYOCARDIAL INFARCTION. DIAGNOSTIC CORONARY ANGIOGRAPHY REVEALED IN-STENT RESTENOSIS WITHIN BOTH DISTAL STENTS. THIS WAS TREATED VIA PERCUTANEOUS CORONARY INTERVENTION. THE PT WAS DISCHARGED ON (B) (6) 2010. THOUGH REQUESTED, NO ADDITIONAL INFO WAS 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 7100541

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention| S STENT:4.0X12MM XIENCE V(PART1009543-12,LOT8091761)