BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1662672 · Received April 16, 2010

    Report

    Report Number
    2024168-2010-00792
    Event Type
    Death
    Date Received
    April 16, 2010
    Date of Event
    March 4, 2010
    Report Date
    March 24, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE XIENCE V 3.0 X 28 MM (PART # 1009541-28/LOT #9031241/(B) (4)); XIENCE V 3.0 X 08 MM (PART # 1009541-08/LOT #711266I/(B) (4)) MENTIONED ARE BEING FILED UNDER THE SAME MANUFACTURER NUMBER. EVALUATION SUMMARY: THERE WAS NO REPORTED PRODUCT DEFICIENCY. DEATH IS A KNOWN ADVERSE EVENT WITH CORONARY STENTING AND IS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    Description of Event or Problem · 1

    ADVERSE EVENT: SHORTNESS OF BREATH, CARDIOPULMONARY ARREST, DEATH. ONSET OF ADVERSE EVENT: SIX MONTHS POST PROCEDURE. DEVICE MALFUNCTION: NONE. IT WAS REPORTED VIA TRIAL THAT ON (B) (6) 2009, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION THAT WAS TREATED WITH A XIENCE STENT IN THE MID LEFT ANTERIOR DESCENDING ARTERY. ON (B) (6) 2009, THE PATIENT UNDERWENT A STAGED PROCEDURE IN THE MID RIGHT CORONARY ARTERY WITH ONE XIENCE V STENT. THERE WERE NO REPORTED DEVICE OR PROCEDURAL ISSUES AND THE PATIENT WAS DISCHARGED ON (B) (6) 2009. ON (B) (6) 2010, THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND BECAME UNRESPONSIVE WITH PULSELESS ELECTRICAL ACTIVITY THAT REQUIRED EMERGENCY PERSONNEL TO ADMINISTER CARDIOPULMONARY RESUSCITATION WITH ENDOTRACHEAL INTUBATION, MECHANICAL VENTILATION, AND HYPOTHERMIA PROTOCOL. THE PATIENT DIED ON (B) (6) 2010. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS AVAILABLE.

    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 9050561

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| H| R (B) (4)| XIENCE V 3.0 X 08 MM (PART #1009541-08/LOT#7112661| XIENCE V 3.0 X 28MM (PART #1009541-28/LOT #9031241| (B) (4)