BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1231564 · Received November 12, 2008

    Report

    Report Number
    2024168-2008-01135
    Event Type
    Death
    Date Received
    November 12, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 14, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. ANGINA, MYOCARDIAL INFARCTION, AND DEATH AS LISTED IN THE PRODUCT IFU ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. ALTHOUGH THE REPORTED PT ISSUES OF ANGINA, MYOCARDIAL INFARCTION, AND DEATH ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING, A CONCLUSIVE ROOT CAUSE FOR ALL THE REPORTED PT ISSUES AND THE RELATIONSHIP TO THE DEVICES, IF ANY, CANNOT BE DETERMINED. THE THREE UNKNOWN PROMUS STENTS ARE BEING FILED UNDER THE SAME MFR#.

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH. REPORTING RATIONALE: MI REQUIRING HOSPITALIZATION/PATIENT DEATH DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THE PT PRESENTED WITH DIFFUSE DISEASE IN THE RCA AND LAD. THE PHYSICIAN STENTED THE RCA WITH AN UNKNOWN NUMBER OF PROMUS STENTS; HE SUBSEQUENTLY STENTED THE LAD WITH 3 OVERLAPPING PROMUS STENTS AND FINISHED WITH ANOTHER COMPANY'S STENT JUST PROXIMAL TO THE PROMUS STENTS. PATIENT EXPERIENCED CHEST PAIN FOR THREE DAYS BEFORE COMING TO THE EMERGENCY ROOM, HE PRESENTED IN THE EMERGENCY ROOM IN 2008, WITH AN ANTERIOR MI AND EXPIRED THAT SAME DAY. THE PT EXPIRED WHILE IN THE HOSPITAL. THE CAUSE OF THE DEATH IS UNKNOWN. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORP DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death| H| L| S STENT: UNKNOWN PROMUS STENT (X 3)