BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3884921 · Received June 19, 2014

    Report

    Report Number
    2024168-2014-03965
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    July 30, 2013
    Report Date
    June 5, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PATIENT EFFECTS OF ANGINA AND RESTENOSIS, AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH THE USE OF CORONARY STENTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INDEX PROCEDURE WAS PERFORMED ON (B)(6) 2009. DURING THE PROCEDURE, A DISSECTION OCCURRED IN THE OBTUSE MARGINAL (OM1) VESSEL, AND THE 2.5 X 28 MM PROMUS STENT WAS IMPLANTED FOR TREATMENT. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL, ON (B)(6) 2009. ON (B)(6) 2013, THE PATIENT PRESENTED WITH CARDIAC CHEST PAIN, AND WAS DIAGNOSED WITH UNSTABLE ANGINA. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY. ANGIOGRAPHY REVEALED IN-STENT RESTENOSIS IN THE MID OM1. ON (B)(6) 2013, THE PATIENT WAS TREATED WITH A CORONARY ARTERY BYPASS GRAFT (CABG) TO THE OM1, AND DISCHARGED ON (B)(6) 2013. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360112 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8100961

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R| S