BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1651387 · Received April 2, 2010

    Report

    Report Number
    2024168-2010-00672
    Event Type
    Death
    Date Received
    April 2, 2010
    Date of Event
    December 1, 2008
    Report Date
    March 10, 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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE 3.5 X 18 XIENCE AND 2.5 X 8 XIENCE, INDICATED ARE BEING FILED UNDER THE SAME MFR#. EVALUATION SUMMARY: THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED HYPERTENSION, THROMBOSIS, AND DEATH ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICE CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. IT WAS ALSO REPORTED THAT THE 2.5 X 8 XIENCE V STENT WAS IMPLANTED WITHOUT PRE-DILATION. IT SHOULD BE NOTED THAT THE XIENCE V IFU STATES: "PRE-DILATE THE LESION WITH A PTCA CATHETER." AS THE PATIENT EFFECTS WERE REPORTED APPROXIMATELY 22 MONTHS POST-PROCEDURE, IT IS UNKNOWN WHETHER NOT PRE-DILATING THE DISTAL LESION CONTRIBUTED TO THE REPORTED PATIENT EFFECTS.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: PULMONARY HYPERTENSION, DEATH. ONSET OF ADVERSE EVENT: APPROXIMATELY 21 MONTHS POST PROCEDURE. IT WAS REPORTED VIA A TRIAL THAT ON (B) (6) 2007, THE PATIENT UNDERWENT STENTING OF THE PREDILATED DISTAL LEFT CIRCUMFLEX ARTERY WITH ONE XIENCE V STENT, THE PREDILATED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH ONE XIENCE V STENT, AND DIRECT STENTING OF THE DISTAL LAD WITH ONE XIENCE V STENT. ON AN UNKNOWN DATE IN (B) (6) 2008, THE PATIENT EXPERIENCED PULMONARY HYPERTENSION AND DIED ON (B) (6) 2009. ABBOTT VASCULAR MEDICAL SAFETY MONITORS ASSESSED THIS EVENT AS A POSSIBLE VERY LATE STENT THROMBOSIS. 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 7050261

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death LOT 7042361)| 2.5 X 8 XIENCE (PART 1009527-08, LOT 7068161)| STENT: 3.5 X 18 MM XIENCE (PART 1009530-18,