BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4243659 · Received November 11, 2014

    Report

    Report Number
    2024168-2014-07345
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    April 28, 2014
    Report Date
    October 25, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. STENOSIS AND ANGINA ARE LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE PROMUS STENT WAS IMPLANTED IN THE DE NOVO 90% LESION IN THE NON-TORTUOUS, MILDLY CALCIFIED, MID LEFT ANTERIOR DESCENDING (MLAD) CORONARY ARTERY ON (B)(6) 2010. 3.5 YEARS LATER, ON (B)(6) 2014, THE PATIENT HAD ANGINA. THE PATIENT VISITED THE HOSPITAL ON (B)(6) 2014, BUT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2014. RESTENOSIS IN THE MLAD TARGET LESION WAS IDENTIFIED WITH A DIAGNOSTIC CORONARY ANGIOGRAM. NO THROMBUS WAS SEEN. THE MLAD WAS TREATED WITH A STENT. THE ANGINA RESOLVED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON (B)(6) 2014. THE STUDY SITE HAS INDICATED THIS RESTENOSIS IS NOT RELATED TO THE PROMUS STENT NOR THE STENTING PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727202 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0061541

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R CLOPIDOGREL, ASPIRIN