BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4136533 · Received October 2, 2014

    Report

    Report Number
    2024168-2014-06361
    Event Type
    Death
    Date Received
    October 2, 2014
    Date of Event
    March 1, 2014
    Report Date
    August 15, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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. THE DATE OF OCCURRENCE HAS BEEN ESTIMATED AS (B)(6) 2014, THE DATE OF PUBLICATION. THE XIENCE V DEVICE REFERENCED, IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WAS NOT PROVIDED. DEATH IS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ARTICLE: ALFAZIR OMAR, MBCHB; REBECCA TORGUSON, MPH; HIRONORI KITABATA, MD, PHD; LAKSHMANA K. PENDYALA, MD; JOSHUA P. LOH, MBBS; MARCO A. MAGALHAES, MD; LOWELL F. SATLER, MD; WILLIAM O. SUDDATH, MD; AUGUSTO D. PICHARD, MD AND RON WAKSMAN, MD. (CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 00:00-00 (2014)): LONG-TERM SAFETY AND EFFICACY OF SECOND-GENERATION EVEROLIMUS-ELUTING STENTS COMPARED TO OTHER LIMUS-ELUTING STENTS AND BARE METAL STENTS IN PATIENTS WITH ACUTE CORONARY SYNDROME.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THAT THE XIENCE V AND PROMUS STENTS MAY BE RELATED TO DEATH. SPECIFIC INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED LONG-TERM SAFETY AND EFFICACY OF SECOND-GENERATION EVEROLIMUS-ELUTING STENTS COMPARED TO OTHER LIMUS-ELUTING STENTS AND BARE METAL STENTS IN PATIENTS WITH ACUTE CORONARY SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616930 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death