BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1142740 · Received August 27, 2008

    Report

    Report Number
    2024168-2008-00731
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 28, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: THROMBOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED THAT THE PT CAME IN WITH A TROPONIN BUMP, AN ESTIMATED TWO DAYS OUT INFARCTION. USING A INTRAVASCULAR ULTRA SOUND (IVUS), IT WAS DECIDED TO IMPLANT THE 3.0X 18 MM PROMUS STENT. AFTER SUCCESSFUL DILATATION OF THE STENT, SIGNIFICANT THROMBUS WAS NOTED. A 2.0X 12 MM BALLOON CATHETER FROM ANOTHER COMPANY WAS USED TO TRY AND COMPRESS THE CLOT DISTAL TO THE PROMUS STENT; THIS WAS MODERATELY SUCCESSFUL. A SECOND BALLOON CATHETER, SIZE 2.5X15MM, WAS USED FOR ADDITIONAL DILATATION. THEN A 2.75 X 18MM PROMUS WAS IMPLANTED DISTAL WITH SUCCESS. DURING THIS TIME, THE PT WAS ALSO GIVEN ADENISINE AND NITRO. TO FINISH THE CASE, PROXIMAL TO THE ORIGINAL PROMUS STENT, A 3.0X8MM PROMUS STENT WAS IMPLANTED. THE ANGIOGRAPHY CONFIRMED IT TO BE SUCCESSFUL. NO ADD'L 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 U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8010241

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention PROWATER| OTHER: EAGLE EYE IVUS| GUIDE WIRE: CORDIS XB 3.5 6F