BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1901999 · Received November 12, 2010

    Report

    Report Number
    2024168-2010-02441
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 23, 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). THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN. REPORTEDLY, NO PRE-DILATATION WAS PERFORMED PRIOR TO IMPLANTING THE XIENCE V STENT. THE IFU STATES THAT THE VESSEL SHOULD BE PRE-DILATED WITH AN APPROPRIATE SIZED BALLOON. FAILURE TO DO SO MAY INCREASE THE DIFFICULTY OF STENT PLACEMENT AND CAUSE PROCEDURAL COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2008 THE PATIENT UNDERWENT DIRECT STENTING IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH ONE 2.75 X 18 XIENCE V STENT AND DIRECT STENTING IN THE FIRST OBTUSE MARGINAL WITH ONE 3.0 X 18 XIENCE V STENT. ON (B)(6) 2010 THE PATIENT EXPERIENCED SUBSTERNAL CHEST PAIN AND WAS FOUND TO HAVE IN-STENT RESTENOSIS OF THE MID LAD REQUIRING PERCUTANEOUS CORONARY REVASCULARIZATION. THE PATIENT'S CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2010. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION 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 8052861

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R VESSEL CLOSURE: ANGIO-SEAL.| STENT: 3.0 X 18 XIENCE V ((B)(4)| LOT 8053061, (B)(4))