BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2981260 · Received February 27, 2013

    Report

    Report Number
    2024168-2013-01150
    Event Type
    Death
    Date Received
    February 27, 2013
    Date of Event
    June 1, 2012
    Report Date
    February 8, 2013
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DATE OF DEATH PROVIDED AS (B)(6) 2012, AND ESTIMATED AS (B)(6) 2012. DATE OF EVENT PROVIDED AS (B)(6) 2012, AND ESTIMATED AS (B)(6) /2012. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM, (B)(4), INSTRUCTIONS FOR USE (IFU) IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS 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 VASCULARS DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 18 MONTHS POST IMPLANTATION OF A PROMUS STENT IN THE RIGHT CORONARY ARTERY, THE PATIENT EXPERIENCED A SERIOUS ADVERSE EVENT. THE SERIOUS ADVERSE EVENT AND THE TREATMENT WERE NOT PROVIDED. FOLLOWING THIS EVENT, THE SUBJECT EXPIRED. CAUSE OF DEATH IS UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83861 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0042961

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death