BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3081520 · Received April 29, 2013

    Report

    Report Number
    2024168-2013-02645
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    January 1, 2012
    Report Date
    February 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. (B)(6) 2012 - ESTIMATED DATE OF EVENT. (B)(6) 2010 - ESTIMATED DATE OF IMPLANT. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECT OF OCCLUSION IS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT 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. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RESEARCH PATHOLOGY OF AN EXPLANTED HEART FOUND 1 UNK PROMUS STENT IMPLANTED IN THE MID RIGHT CORONARY ARTERY (MRCA) AND 1 PROMUS AND 2 NON-ABBOTT STENTS IN THE PROXIMAL LEFT MAIN, LEFT ANTERIOR DESCENDING AND LEFT CIRCUMFLEX CORONARY ARTERIES. THE PROMUS STENT IN THE MRCA SHOWED NEOATHEROSCLEROSIS. THE CAUSE OF DEATH WAS NONCARDIAC DEATH. THE EVENTS OCCURRED 520 DAYS POST STENT IMPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183912 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other STENT: PROMUS (X1), CYPHER (X2)