BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1674936 · Received May 4, 2010

    Report

    Report Number
    2024168-2010-00913
    Event Type
    Injury
    Date Received
    May 4, 2010
    Date of Event
    February 1, 2010
    Report Date
    April 9, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION. THE 3.0 X 8 MM XIENCE V (PART 1009553-08, LOT 6053151), INDICATED IS BEING FILED UNDER THE SAME MANUFACTURER NUMBER.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: ANGINA AND RESTENOSIS REQUIRING INTERVENTION. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED VIA TRIAL THAT ON (B) (6) 2007, THE PT UNDERWENT STENTING IN THE PREDILATED DISTAL RIGHT CORONARY ARTERY (RCA) WITH ONE XIENCE V STENT AND IN THE PREDILATED MID RCA WITH ONE XIENCE V STENT. ON AN UNSPECIFIED DATE IN (B) (6) 2010, THE PT EXPERIENCED ANGINA THAT WAS TREATED WITH DIAGNOSTIC CORONARY ANGIOGRAPHY AND REVASCULARIZATION ON (B) (6) 2010, IN THE MID RCA WITH THE PLACEMENT OF ONE NON-ABBOTT STENT AND IN THE PROXIMAL RCA WITH THE PLACEMENT OF ONE NON-ABBOTT STENT. THE PT'S SYMPTOMS RESOLVED ON (B) (6) 2010. NO ADDITIONAL INFORMATION 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 60601P1

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R STENT:3.0X8MM XIENCE V(PART 1009553-08,LOT6053151)