BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1211538 · Received October 22, 2008

    Report

    Report Number
    2024168-2008-01002
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 25, 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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - THROMBOSIS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PT EFFECTS, AND THE RELATIONSHIP TO THE DEVICES, IF ANY, CANNOT BE DETERMINED. IT SHOULD BE NOTED THAT THE IFU STATES, "THE PROMUS STENT IS CONTRAINDICATED FOR USE IN PTS WHO CANNOT RECEIVE ANTIPLATELET AND/OR ANTI-COAGULANT THERAPY... IT IS VERY IMPORTANT THAT THE PT IS COMPLIANT WITH THE POST-PROCEDURAL ANTIPLATELET THERAPY RECOMMENDATIONS. EARLY DISCONTINUATION OF PRESCRIBED ANTIPLATELET MEDICATION COULD RESULT IN A HIGHER RISK OF THROMBOSIS, MI, OR DEATH."

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: THROMBOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THE PT HAD A STAINLESS STEEL STENT IMPLANTED ABOUT FOUR YEARS AGO. THE PT HAD STOPPED TAKING PLAVIX ABOUT TWO MONTHS BEFORE PRESENTING WITH THROMBUS IN THE EXISTING STENT. A PROMUS STENT WAS IMPLANTED AND 4 TO 5 HOURS LATER, PRESENTED WITH THROMBUS INSIDE THE PROMUS STENT. IT WAS TREATED BY PULLING THE CLOT OUT AND THE PT WAS PUT ON PLAVIX. 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 UNK Required Intervention