BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1273702 · Received December 22, 2008

    Report

    Report Number
    2024168-2008-01467
    Event Type
    Death
    Date Received
    December 22, 2008
    Date of Event
    November 21, 2008
    Report Date
    November 29, 2008
    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

    THE FIVE ADDITIONAL XIENCE V STENTS (XIENCE V 2.5 X 28 (PART # 1009539-28/LOT# 8071761); XIENCE V 2.5 X 23 MM (PART# 1009539-23/LOT# 8061761); XIENCE V 3.5 X 23 MM (PART # 1009542-23)/LOT# 8052641); XIENCE V 2.5 X 12 MM (PART# 1009539-12/LOT# 8070261); XIENCE V 2.5 X 18MM (PART # 1009539-18/LOT # 8071661) ARE BEING FILED UNDER THE SAME MANUFACTURER NUMBER.

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH. REPORTING RATIONALE: THE PATIENT HAD AN MI AND DIED; UNKNOWN IF RELATED TO THE DEVICE. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA TRIAL THAT THE PATIENT HAD AN ACUTE MYOCARDIAL INFARCTION AND DIED AT HOME. THE PATIENT HAD SIX XIENCE V STENTS IMPLANTED IN 2008. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS 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 8062361

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| S XIENCE V (PART# 1009539-28/LOT#8071761)| PART# 1009542-23/LOT# 8052641| PART# 1009539-23/LOT# 8061761| PART# 1009539-18/LOT# 8071661| PART# 1009539-12/LOT# 8070261