BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3913839 · Received July 3, 2014

    Report

    Report Number
    2024168-2014-04358
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 11, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE ANATOMY. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED, BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF ANGINA, DYSPNEA, MYOCARDIAL INFARCTION AND NAUSEA, 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. 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 A DE NOVO LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA, CASS SITE# 1) WITH 95% STENOSIS AND WAS 14 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. ON (B)(6) 2011 THE LESION WAS TREATED WITH DIRECT PLACEMENT OF A 3.00 X 16 MM NON-ABBOTT STENT. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS 0%. ON (B)(6) 2012 THE SUBJECT EXPERIENCED CHEST PAIN AND IN-STENT RESTENOSIS WAS NOTED AND TARGET VESSEL REVASCULARIZATION WITH A 3.0 X 16 MM PROMUS STENT WAS IMPLANTED IN THE PROXIMAL RCA WITHOUT REPORTED ISSUE. ON (B)(6) 2014, 1084 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED WITH EXERTIONAL CHEST PAIN, SUBSTERNAL CHEST PRESSURE RADIATING TO NECK AND LEFT ARM ASSOCIATED WITH NAUSEA, SHORTNESS OF BREATH AND DIAPHORESIS AND WAS HOSPITALIZED ON SAME DAY. THE SUBJECT WAS DIAGNOSED WITH ST SEGMENT ELEVATED MYOCARDIAL INFARCTION AND CARDIAC CATHETERIZATION WAS RECOMMENDED. AT THE TIME OF EVENT, THE SUBJECT WAS ONLY ON ASPIRIN; THE STUDY DRUG WAS LAST TAKEN ON (B)(6) 2012 AND OTHER ANTIPLATELET MEDICATION WAS LAST TAKEN ON (B)(6) 2013. ON (B)(6) 2014, 1084 DAYS POST INDEX PROCEDURE, 99% TOTAL OCCLUSION OF THE STUDY STENT AND THE PROMUS STENT IN THE PROXIMAL RCA (CASS SITE # 1) WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 3.0 X 20 MM PROMUS STENT. ON (B)(6) 2014, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY ON ASPIRIN AND CLOPIDOGREL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389854 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R| S