BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 7284339 · Received February 20, 2018

    Report

    Report Number
    2024168-2018-01260
    Event Type
    Death
    Date Received
    February 20, 2018
    Date of Event
    December 7, 2017
    Report Date
    April 18, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO ABBOTT DEVICES WERE REPORTED AS IMPLANTED. AS THIS WAS PREVIOUSLY REPORTED, IT MUST REMAIN REPORTABLE. NO INVESTIGATION REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). INTERNAL FILE NUMBER - (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL 30-DAY MEDWATCH REPORT FILED, THE FOLLOWING INFORMATION WAS RECEIVED: ON (B)(6) 2013, 4 NON-ABBOTT STENTS WERE SUCCESSFULLY IMPLANTED. ON (B)(6) 2017, THE PATIENT DIED UNDER HOSPICE CARE FROM ATHEROSCLEROTIC HEART DISEASE, HYPERTENSION AND CHRONIC KIDNEY DISEASE. NO ABBOTT DEVICES WERE REPORTED AS IMPLANTED. AS THIS WAS PREVIOUSLY REPORTED, IT MUST REMAIN REPORTABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, TWO PROMUS STENTS WERE SUCCESSFULLY IMPLANTED IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY. ON (B)(6) 2017, OVER 4 YEARS POST STENT IMPLANTATION, THE PATIENT DIED FROM UNSPECIFIED CAUSES. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125623 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death