BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2861735 · Received December 7, 2012

    Report

    Report Number
    2024168-2012-07725
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    April 28, 2011
    Report Date
    November 12, 2012
    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). DATE OF EVENT CORRECTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. 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 AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DATE OF EVENT WAS (B)(6) 2011 AND THE DATE OF DISCHARGE WAS (B)(6) 2011.

    Description of Event or Problem · 1

    ON (B)(6) 2010, DUE TO POSITIVE STRESS TEST, THE SUBJECT UNDERWENT THE INDEX PROCEDURE WITH THE DEPLOYMENT OF ONE PROMUS DRUG ELUTING STENT TO THE FIRST DIAGONAL ARTERY. POST PROCEDURE RESIDUAL STENOSIS WAS 0 % WITH TIMI 3 FLOW. THE SUBJECT DID NOT RECEIVE A PERI-PROCEDURAL LOADING DOSE OF THE THIENOPYRIDINE MEDICATION. 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 325.0 MG. ON (B)(6) 2010, THE SUBJECT WAS DISCHARGED FROM THE INDEX HOSPITALIZATION. ON (B)(6) 2011, THE SUBJECT WAS RANDOMIZED TO RANDOMIZATION TREATMENT AND WAS ADMINISTERED THE FIRST DOSE ON (B)(6) 2011. ON (B)(6) 2012, THE SUBJECT EXPERIENCED THE EVENT OF ANEMIA AND WAS EXPERIENCING SHORTNESS OF BREATH, GENERAL WEAKNESS, AND LIGHTHEADEDNESS. THE PATIENT WAS REHOSPITALIZED AND UNDERWENT A BLOOD TRANSFUSION FOR ANEMIA. THE SYMPTOMS OF ANEMIA WERE DETERMINED TO BE RELATED TO THE STUDY DEVICE. NO ADDITIONAL 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 9041062

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R