BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3140803 · Received May 31, 2013

    Report

    Report Number
    2024168-2013-03428
    Event Type
    Death
    Date Received
    May 31, 2013
    Date of Event
    February 12, 2013
    Report Date
    May 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. DEATH IS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT. 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. 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 PROMUS STENT REFERENCED HAS PREVIOUSLY BEEN REPORTED UNDER SEPARATE MEDWATCH REPORT #2024168-2012-04162.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1432 DAYS POST PROMUS STENT IMPLANT, THE SUBJECT WAS DIAGNOSED WITH END-STAGE CARDIOMYOPATHY. ON (B)(6) 2013, 1442 DAYS POST PROCEDURE, THE SUBJECT DIED AND THE CAUSE OF DEATH WAS NOTED AS END-STAGE CARDIOMYOPATHY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241687 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8111761

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death