BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2874440 · Received December 14, 2012

    Report

    Report Number
    2024168-2012-07974
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    July 14, 2012
    Report Date
    November 19, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE REMAINS IN THE PATIENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA IS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN ADVERSE PATIENT EVENT ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2010, DUE TO STABLE ANGINA, THE SUBJECT UNDERWENT THE INDEX PROCEDURE WITH THE DEPLOYMENT OF A DRUG ELUTING STENT (DES) TO THE FIRST OBTUSE MARGINAL ARTERY. POST PROCEDURE RESIDUAL STENOSIS WAS 0 % WITH TIMI 3 FLOW. ON (B)(6) 2010, THE SUBJECT RECEIVED A PERI-PROCEDURAL LOADING DOSE OF THE THIENOPYRIDINE MEDICATION CLOPIDOGREL DOSE 300.0 MG. ON (B)(6) 2010, AT THE START OF THE STUDY THE SUBJECT RECEIVED THE STUDY MEDICATION MAINTENANCE DOSE OF CLOPIDOGREL DOSE 75.0 MG. ON (B)(6) 2010, THE SUBJECT WAS STARTED ON ASPIRIN DOSE 162.0 MG. ON (B)(6) 2010, THE SUBJECT WAS DISCHARGED FROM THE INDEX HOSPITALIZATION. ON (B)(6) 2011, THE SUBJECT WAS RANDOMIZED TO CLOPIDOGREL OR PLACEBO AND WAS ADMINISTERED THE FIRST DOSE ON (B)(6) 2011. ON (B)(6) 2012, THE SUBJECT EXPERIENCED THE EVENT OF CHEST PAIN 886 DAYS FOLLOWING THE INDEX PROCEDURE. THE EVENT WAS REPORTED WITH THE SERIOUS CRITERIA OF INITIAL OR PROLONGED HOSPITALIZATION. IT WAS NOTED THAT THE OUTCOME OF THE EVENT IS RECOVERED OR RESOLVED. NO FURTHER 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 49 YR Hospitalization