BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1224243 · Received November 5, 2008

    Report

    Report Number
    2024168-2008-01071
    Event Type
    Death
    Date Received
    November 5, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 6, 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
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS BEING FILED UNDER THE SAME MFR#.

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH. REPORTING RATIONALE: THROMBOSIS/CARDIAC ARREST RESULTING IN DEATH. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THE PT PRESENTED WITH AN AMI AND A FULL CLOT IN THE LEFT ANTERIOR DESCENDING (LAD). ASPIRATION OF THE CLOT WAS DONE MANUALLY AND THE CLOT WAS COMPLETELY REMOVED. TWO PROMUS STENTS WERE IMPLANTED SUCCESSFULLY AND THE PT WAS STABLE. AFTER 10 MIN, THE PT WENT INTO CARDIAC ARREST, AND WHEN CHECKED, THEY FOUND FULL STENT THROMBOSIS. ACUTE STENT THROMBOSIS BLOCKED THE LAD. IN TRYING TO SAVE THE PT, ANOTHER COMPANY'S STENT WAS IMPLANTED IN THE LEFT MAIN; HOWEVER, THE PT DIED. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOT 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 8061241

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| L| R SYSTEM (LOT# 8061041)| STENT: PROMUS EVEROLIMUS ELUTING CORONARY STENT