BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2955188 · Received February 11, 2013

    Report

    Report Number
    2024168-2013-00774
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    November 5, 2012
    Report Date
    January 17, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE U.S. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ISCHEMIA AND MYOCARDIAL INFARCTION ARE LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS. 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, DESIGN, OR LABELING. THE ADDITIONAL PROMUS STENTS REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, DUE TO CHEST PAIN, THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH THE DEPLOYMENT OF TWO DRUG-ELUTING STENTS TO THE DISTAL CIRCUMFLEX ARTERY AND ONE DRUG ELUTING STENT TO THE PROXIMAL CIRCUMFLEX ARTERY. POST RESIDUAL STENOSIS WAS 30 % WITH TIMI 3 FLOW IN THE DISTAL CIRCUMFLEX LESION AND POST RESIDUAL STENOSIS WAS 0 % WITH TIMI 3 FLOW IN THE PROXIMAL CIRCUMFLEX LESION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. ON (B)(6) 2012 THE PATIENT WAS EXPERIENCING RECURRENT ISCHEMIC SYMPTOMS, A CARDIAC ENZYME TEST AND ANGIOGRAPHY WAS PERFORMED AND THE SYMPTOMS WERE DIAGNOSED AS A POTENTIAL MYOCARDIAL INFARCTION (MI). THERE WAS NO REPORTED TREATMENT OF THE MI. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59760 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0050441

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Disability STENT: PROMUS (X2)