BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1729701 · Received June 16, 2010

    Report

    Report Number
    2024168-2010-01188
    Event Type
    Injury
    Date Received
    June 16, 2010
    Date of Event
    May 18, 2010
    Report Date
    May 22, 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). THERE WAS NO REPORTED DEFICIENCY. ANGINA, ISCHEMIA AND STENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT 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, DESIGN, OR LABELING. THE XIENCE V (PART 1009539-28, LOT 8041842), IS BEING FILED UNDER THIS MFR#.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: RESTENOSIS REQUIRING INTERVENTION. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED VIA TRIAL THAT ON (B) (6) 2008, THE PT UNDERWENT DIRECT STENTING IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH ONE XIENCE V STENT, THE PREDILATED LEFT DISTAL CIRCUMFLEX ARTERY WITH ONE XIENCE V STENT, AND DIRECT STENTING IN THE SAPHENOUS VEIN GRAFT (SVG) WITH ONE XIENCE V STENT. ON (B) (6) 2010, THE PT HAD A STRESS TEST THAT SHOWED MILD TO MODERATE INFEROLATERAL ISCHEMIA THAT WAS DIAGNOSED AS UNSTABLE ANGINA. THE PT UNDERWENT DIAGNOSTIC CORONARY ANGIOGRAPHY ON (B) (6) 2010; PERCUTANEOUS CORONARY INTERVENTION WITH BALLOON DILATATION ONLY IN THE PROXIMAL LEFT CIRCUMFLEX AND SVG TARGET VESSELS. THE PT'S CONDITION RESOLVED AND THE PT WAS DISCHARGED ON (B) (6) 2010. 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 8052961

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention XIENCE V (PART 1009542-28, LOT 8022261)| VESSEL CLOSURE: PERCLOSE| STENT: XIENCE V (PART 1009539-28, LOT 8041842)