BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1726236 · Received June 15, 2010

    Report

    Report Number
    2024168-2010-01183
    Event Type
    Injury
    Date Received
    June 15, 2010
    Date of Event
    May 12, 2010
    Report Date
    May 21, 2010
    Manufacturer
    ABBOTT VASCULAR CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE SECOND XIENCE V RX 2.75X 28 MM (PART#1009540-28/LOT#0021541) MENTIONED IS BEING FILED UNDER THE SAME MANUFACTURER NUMBER. IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED CARDIAC ARREST AND THROMBOSIS ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    ADVERSE EVENT: CARDIAC ARREST, THROMBUS REQUIRING INTERVENTION. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. DEVICE ISSUE: NONE. IT WAS REPORTED THAT ON (B) (6) 2010, THE PT UNDERWENT STENTING IN THE LEFT ANTERIOR DESCENDING ARTERY WITH A NON-ABBOTT STENT. ON (B) (6) 2010, THE PT DEVELOPED VENTRICULAR FIBRILLATION AND SUBSEQUENTLY UNDERWENT STENTING IN THE RIGHT CORONARY ARTERY (RCA) WITH TWO XIENCE V STENTS AND ONE NON-ABBOTT STENT. ON (B) (6) 2010, THE PT EXPERIENCED ACUTE CARDIAC ARREST. CORONARY ANGIOGRAPHY REVEALED STENT THROMBOSIS IN THE RCA THAT WAS ASPIRATED WITH AN ASPIRATION CATHETER. THE PT WAS TREATED WITH PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) AND INTRA AORTIC BALLOON PUMP. THE PT REMAINS ON THE PCPS AT THIS TIME. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR CLONMEL NA 0020141

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R STENT: 3.5 X 24 ENDEAVOR| XIENCE V RX 2.75X28MM(PART#1009540-28/LOT#0021541)