BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3082825 · Received April 29, 2013

    Report

    Report Number
    2024168-2013-02650
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    August 22, 2011
    Report Date
    April 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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, CORONARY ARTERY BYPASS (CABG), AND RESTENOSIS AS LISTED IN THE PROMUS EVEROLIMUS ELUTING STENT SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE 4.0 X 18 MM PROMUS STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. ON (B)(6) 2011, THE PATIENT WAS REHOSPITALIZED FOR EXERTIONAL CHEST PAIN. ANGIOGRAPHY WAS PERFORMED WHICH REVEALED RESTENOSIS OF THE PROMUS STENT FOR WHICH THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS PROCEDURE OF THE SAPHENOUS VEIN GRAFT TO THE MID LEFT ANTERIOR DESCENDING ARTERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185169 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0011561

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R| S