BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1656775 · Received April 8, 2010

    Report

    Report Number
    2024168-2010-00716
    Event Type
    Death
    Date Received
    April 8, 2010
    Date of Event
    March 14, 2010
    Report Date
    March 15, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE PROMUS STENT (PART# 1009541-23B, LOT# UNK) AND PROMUS STENT (PART# 1009542-12B, LOT# 9092241) INDICATED ARE BEING FILED UNDER THE SAME MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: THROMBOSIS AND DEATH. TIME OF ADVERSE EVENT: POST STENTING PROCEDURE. IT WAS REPORTED THAT ON (B) (6) 2010, A 3.5X18 RX PROMUS WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, AND A 3.0X23 RX PROMUS WAS IMPLANTED IN THE MID-LAD. ON (B) (6) 2010, ANOTHER PCI PROCEDURE WAS PERFORMED, DURING WHICH A 3.5X12 RX PROMUS, AND A 3.0X18 NON-BOSTON SCIENTIFIC STENT WERE IMPLANTED IN THE MID-RIGHT CORONARY ARTERY. STENT THROMBOSIS WAS NOTED. AFTER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, THE PATIENT HAD SLIGHT CHEST PAIN AND WAS TAKEN BACK TO THE HOSPITAL. WHEN THE PATIENT ARRIVED AT THE HOSPITAL, THE PATIENT STATUS WAS CARDIAC ARREST. ALTHOUGH AN IABP WAS PERFORMED, AND THE PATIENT UNDERWENT AN URGENT PROCEDURE, THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED. (B) (4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 9091161

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death PROMUS STENT (PART# 1009542-12B, LOT# 9092241)| DIL CATH: SPRINTER 1.5X15MM| NC SPRINTER 2.75X12MM| GUIDE WIRE: FIELDER FC| RUNTHROUGH| PROMUS STENT (PART# 1009541-23B, LOT# UNK)| GUIDE CATH: LAUNCHER EBU 3.25| 3.0X12MM| 2.5X15MM