BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1599238 · Received February 5, 2010

    Report

    Report Number
    2024168-2010-00203
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    January 8, 2010
    Report Date
    January 12, 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 2.5 X 8 MM XIENCE V (PART 1009539-08, LOT 7111341), INDICATED IS BEING FILED UNDER MFR # 2024168-2010-00202. THE 2.5 X 15 MM XIENCE V (PART 1009539-15, LOT 9071741), INDICATED IS BEING FILED UNDER ANOTHER MFR #.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT PREDILATATION WAS PERFORMED PRIOR TO STENTING OF THE PROXIMAL LAD. A DISSECTION OCCURRED DURING DEPLOYMENT OF THE FIRST XIENCE V STENT (1009539-23). ANOTHER XIENCE V STENT WAS PLACED OVERLAPPING THE FIRST STENT (1009539-15) WHICH ALSO RESULTED IN A DISSECTION, WHICH WAS TREATED WITH ANOTHER XIENCE V STENT (1009539-08). THIS LAST STENT IMPLANTED; HOWEVER, WAS USED AFTER THE EXPIRATION DATE. REPORTED EXPIRATION DATE IS 12/04/2009. THERE WERE NO REPORTED PT EFFECTS OR ADVERSE EVENTS. THERE WAS NO ADD'L EVENT INFO REPORTED.

    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 9070961

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention STENT: 2.5 X 8 MM XIENCE V| (1009539-15/ (B) (4))| (1009539-08/ (B) (4))| 2.5 X 15 MM XIENCE V