BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1805016 · Received August 13, 2010

    Report

    Report Number
    2024168-2010-01663
    Event Type
    Injury
    Date Received
    August 13, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 20, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROMUS 3.0 X 28 MM (PART# 1009547-28B/LOT# 9010961) AND PROMUS 3.0 X 28 MM (PART# 1009547-28B/LOT# 8081361) MENTIONED ARE BEING FILED UNDER SEPARATE MANUFACTURER NUMBERS. THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE LOT HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: MYOCARDIAL INFARCTION WITH TARGET VESSEL REVASCULARIZATION. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED THAT THE THREE PROMUS STENTS WERE PLACED IN THE RIGHT CORONARY ARTERY (RCA) ON (B)(6) 2009. ON (B)(6) 2010, THE PATIENT RETURNED TO THE HOSPITAL DUE TO SYMPTOMS OF ISCHEMIA, ELEVATED CARDIAC ENZYMES, NEW ECG CHANGES AND WAS DIAGNOSED WITH A MYOCARDIAL INFARCTION. ANGIOGRAPHY WAS PERFORMED AND REVEALED THAT THE MID RCA WAS FOUND TO HAVE 70% RESTENOSIS AND PROXIMAL RCA WAS FOUND TO HAVE 90% RESTENOSIS, WHICH REQUIRED TREATMENT WITH THREE ADDITIONAL STENTS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8121661

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R| S PROMUS 3.0 X 28 MM| (PART# 1009547-28B/LOT# 8081361)| PROMUS 3.0 X 28 MM| (PART# 1009547-28B/LOT# 9010961)