BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3200389 · Received July 1, 2013

    Report

    Report Number
    2024168-2013-04135
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    November 15, 2012
    Report Date
    June 6, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ATRIAL FIBRILLATION IS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009 THE SUBJECT WAS RANDOMIZED INTO THE STUDY WITH A PROCEDURE TO THE 95% STENOSIS, MID RIGHT CORONARY ARTERY (RCA) WITH PLACEMENT OF A 2.50 X 28 MM STUDY STENT AND POST DILATATION WITH 0% STENOSIS. THE SUBJECT WAS DISCHARGED ON (B)(6) 2009. ON (B)(6) 2009, THE SUBJECT EXPERIENCED STABLE ANGINA. ON (B)(4) 2010, THE SUBJECT EXPERIENCED A PERFORATED DIVERTICULITIS WITH ABSCESS; IN (B)(6) 2011 THE SUBJECT EXPERIENCED ATRIAL FIBRILLATION AND IN (B)(6) 2012 A HERNIATED SPINAL DISK. THE SITE REPORTED AN EVENT OF ATRIAL FIBRILLATION WITH THE ONSET OF (B)(6) 2012 AND THE SUBJECT WAS HOSPITALIZED; 1240 DAYS POST INDEX PROCEDURE AND TREATED WITH MEDICATION AS WELL AS UNDERWENT ANGIOGRAPHY WITHOUT REVASCULARIZATION. IN THE SAME MONTH THE EVENT RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300261 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8100961

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R