BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2818018 · Received November 2, 2012

    Report

    Report Number
    2024168-2012-06931
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    July 19, 2012
    Report Date
    October 10, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA, MYOCARDIAL INFARCTION, AND RESTENOSIS, AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN ADVERSE PATIENT EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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. 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 US. THE ADDITIONAL PROMUS STENT, REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE SUBJECT RECEIVED TWO 18 MM PROMUS STENTS TO THE PROXIMAL CIRCUMFLEX ARTERY. ADDITIONALLY, ON (B)(6) 2010 THE SUBJECT UNDERWENT DIRECT STENTING OF THE FIRST DIAGONAL WITH 90% STENOSIS USING A 2.25 X 8 MM NON-ABBOTT STENT WITH 0% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED THE FOLLOWING DAY. ON (B)(6) 2012, 805 DAYS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED CHEST PAIN AND THE SUBJECT WAS HOSPITALIZED ON THE SAME DAY. CARDIAC ENZYMES WERE NOTED TO BE ELEVATED AND THE SUBJECT WAS DIAGNOSED WITH MYOCARDIAL INFARCT WITH A RECOMMENDATION FOR CARDIAC CATHETERIZATION. CORONARY ANGIOGRAPHY WAS PERFORMED AND REVEALED TOTAL OCCLUSION OF THE FIRST DIAGONAL BRANCH WITH A PATENT STENT IN THE PROXIMAL SEGMENT AND IN-STENT RESTENOSIS AT THE OSTIUM OF THE CIRCUMFLEX. A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS ATTEMPTED; HOWEVER, MULTIPLE ATTEMPTS TO CROSS THE TOTAL OCCLUSION IN THE OXTAIL CIRCUMFLEX WITH NON-ABBOTT GUIDE WIRES AND OTHER WIRES WERE UNSUCCESSFUL. THE PROCEDURE WAS TERMINATED AND THE SUBJECT WAS TREATED MEDICALLY WITH IV NITROGLYCERIN AND MORPHINE. ON (B)(6) 2012, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECT AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY. 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-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R| S GUIDE WIRE: KINETIX