BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 5890052 · Received August 19, 2016

    Report

    Report Number
    2024168-2016-05550
    Event Type
    Death
    Date Received
    August 19, 2016
    Date of Event
    January 1, 2016
    Report Date
    August 19, 2016
    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 EVENT: ESTIMATED; DATE OF IMPLANT: ESTIMATED ; THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE STENT REMAINS IN THE ANATOMY. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE; AS A KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. 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. THE XIENCE DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABBOTT VASCULAR'S XIENCE DRUG ELUTING STENT SYSTEM AND BOSTON SCIENTIFIC'S PROMUS DRUG ELUTING STENT SYSTEM THAT MAY BE RELATED TO PATIENT DEATH. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE IN THE ARTICLE TITLED: "SAME OR DIFFERENT DRUG-ELUTING STENT RE-IMPLANTATION FOR DRUG-ELUTING STENT RESTENOSIS: AN ASSESSMENT INCLUDING SECOND-GENERATION DRUG-ELUTING STENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541004 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death