BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3601033 · Received January 30, 2014

    Report

    Report Number
    2024168-2014-00545
    Event Type
    Injury
    Date Received
    January 30, 2014
    Date of Event
    January 6, 2013
    Report Date
    January 9, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA, MYOCARDIAL INFARCTION, OCCLUSION, AND THROMBOSIS ARE KNOWN OBSERVED AND POTENTIAL PATIENT EFFECTS AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU). 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. 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 VISION REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER. THE PATIENT EXPIRED ON 04/03/2013 WHICH WAS PREVIOUSLY REPORTED UNDER MFR REPORT# 2024168-2013-03521.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2010 DURING WHICH A TAXUS LIBERTE STENT WAS DEPLOYED IN THE MID RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2012, THE PATIENT WAS ADMITTED WITH SEVERE CHEST PAIN AND UNDERWENT TARGET VESSEL REVASCULARIZATION WITH PLACEMENT OF A 3.5 X 38 MM PROMUS STENT. ON (B)(4) 2013, 907 DAYS POST INDEX PROCEDURE, THE PATIENT WAS ADMITTED WITH CHEST PAIN AND ELECTROCARDIOGRAM (ECG) REVEALED ST ELEVATION MYOCARDIAL INFARCTION AND THROMBOSIS IN THE PROXIMAL RCA WHICH WAS TREATED WITH ASPIRATION THROMBECTOMY, AND PLACEMENT OF A VISION STENT. ON (B)(6) 2013, THE PATIENT HAD MILD CHEST DISCOMFORT AND ANGIOGRAPHY REVEALED OUTFLOW OBSTRUCTION AT THE END OF THE STENTED SEGMENT AND CORONARY ARTERY BYPASS GRAFT (CABG) WAS RECOMMENDED. ON (B)(6) 2014, THE PATIENT WAS TREATED WITH TWO CABG FROM INTERNAL MAMMARY ARTERY (IMA) TO RCA AND SAPHENOUS VEIN GRAFT (SVG) TO RIGHT AC MARGINAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64996 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R| S