BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1817719 · Received August 23, 2010

    Report

    Report Number
    2024168-2010-01742
    Event Type
    Injury
    Date Received
    August 23, 2010
    Date of Event
    November 11, 2009
    Report Date
    July 29, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE 3.5 X 18 MM PROMUS (PART 1009542-18B LOT 8072961) IS BEING FILED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: RESTENOSIS. ONSET OF ADVERSE EVENT: APPROXIMATELY 11 MONTHS AFTER THE PROCEDURE. IT WAS REPORTED VIA A TRIAL THAT APPROXIMATELY 11 MONTHS POST A PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY STENTING PROCEDURE WITH 2 PROMUS STENTS, THE PATIENT EXPERIENCED ANGINA. ON (B)(6) 2009, IN-STENT RESTENOSIS WAS FOUND AND A CUTTING BALLOON PROCEDURE WAS PERFORMED. ONE DAY POST-PROCEDURE, THE EVENT RESOLVED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED. 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 U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8090362

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization STENT: 3.5 X 18 MM PROMUS (PART 1009542-18B| LOT 8072961)