BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1200660 · Received October 17, 2008

    Report

    Report Number
    2024168-2008-00968
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 17, 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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM, PART #1009540-12B LOT#8030661, AND IS BEING FILED UNDER THE SAME MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION/PERMANENT IMPAIRMENT. REPORTING RATIONALE: STEMI AND SUB-ACUTE THROMBOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT IN 2008, TWO 2.75 X 12 MM PROMUS STENTS WERE IMPLANTED IN THE CX AND THE OM. ON TWELVE DAYS LATER, THE PT RETURNED WITH STEMI. ANGIOGRAPHY WAS PERFORMED AND IN-STENT THROMBOSIS WAS OBSERVED. THE THROMBOSIS WAS TREATED WITH ASPIRATION AND BALLOONING. THE PT IS REPORTED TO BE STABLE. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION 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 8030661

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R| S PART#1009540-12 LOT#8030661| STENT: 2.75 X 12 MM PROMUS