BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1926389 · Received December 14, 2010

    Report

    Report Number
    2024168-2010-02736
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    April 21, 2009
    Report Date
    November 19, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECT OF MYOCARDIAL INFARCTION IS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE MID RIGHT CORONARY ARTERY A 3.5X18 RX PROMUS WAS DEPLOYED AFTER PRE-DILATATION WITH 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, CARDIAC ENZYMES WERE NOTED TO BE ELEVATED AND A MYOCARDIAL INFARCTION WAS DIAGNOSED. NO TREATMENT WAS ADMINISTERED AND THE CONDITION RESOLVED WITHOUT RESIDUAL EFFECT. THE PATIENT WAS DISCHARGED ONE DAY POST-PROCEDURE WITH ASPIRIN AND CLOPIDOGREL PRESCRIBED. PER PHYSICIAN, THE RELATIONSHIP OF THE ADVERSE EVENT TO THE INDEX PROCEDURE IS PROBABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-CLONMEL 8092941

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Disability CLOPIDOGREL, ASPIRIN