BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1658011 · Received April 9, 2010

    Report

    Report Number
    2024168-2010-00734
    Event Type
    Death
    Date Received
    April 9, 2010
    Date of Event
    March 17, 2010
    Report Date
    March 17, 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
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. DEATH IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTION FOR USE (IFU) AND NO FAULT RISK ASSESSMENT MATRIX. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MFR, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: PT DEATH. ONSET OF ADVERSE EVENT: AFTER USE. THE PT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION. THE TREATMENT LESION WAS IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED WITH A NON-ABBOTT DILATATION DEVICE AND THEN THE XIENCE V STENT WAS DEPLOYED. JUST AFTER THE STENT DEPLOYMENT, THE PT EXPIRED. THE PT WAS CRITICAL AND "REOPRO" WAS GIVEN; HOWEVER, THE PT STILL DID NOT SURVIVE. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR CLONMEL NA 9081841

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death GUIDE CATHETER: EBU| GUIDE WIRE: GALEO| DILATATION CATHETER: SPRINTER