BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1604422 · Received February 5, 2010

    Report

    Report Number
    2024168-2010-00200
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    January 8, 2010
    Report Date
    January 12, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF LABELS ATTACHED TO THE LHR FOR THIS LOT WAS CONDUCTED. ALL LABELS INDICATED THE EXP. DATE 01-06-2010, WHICH IS 365 DAYS FROM THE DATE OF MAN. (B)(6) 2009, AS SPECIFIED IN THE PRODUCT SPECIFICATION AT THE TIME OF THIS LOT WAS MANUFACTURED. CONFIRMING THAT THE PRODUCT WAS LABELED CORRECTLY AND BASED ON THE REPORTED INFORMATION; THE PRODUCT WAS USED 2 DAYS PAST THE LABELED EXP. DATE. THE EXP. DATE OF THE PRODUCT IS IMPORTANT FOR THE STERILITY, EFFICACY AND PERFORMANCE OF THE DEVICE. THE PROMUS IFU STATES: "DO NOT USE AFTER THE (USE BY) DATE." IT APPEARS THAT USE ERROR LIKELY CONTRIBUTED TO THE REPORTED USE AFTER EXPIRATION. THE 1ST PROMUS STENT (1009542-12B/8121241), HAS BEEN FILED UNDER MFR# 2024168-2010-00199.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: AN EXPIRED STENT HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. DEVICE ISSUE: EXPIRED STENT. IT WAS REPORTED THAT THE STENTS IMPLANTED IN THE RIGHT CORONARY ARTERY AND THE CIRCUMFLEX ARTERY, WERE USED AFTER THE EXPIRATION DATE. THERE WERE NO REPORTED PATIENT EFFECTS OR ADVERSE EVENTS. THERE WAS NO ADDITIONAL EVENT INFORMATION REPORTED. 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 8121561

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STENT: 3.5 X 12 MM PROMUS| (PART 1009542-12B, LOT 8121241)