BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1414486 · Received July 10, 2009

    Report

    Report Number
    2024168-2009-01216
    Event Type
    Injury
    Date Received
    July 10, 2009
    Date of Event
    May 12, 2009
    Report Date
    June 16, 2009
    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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWO OTHER PROMUS STENTS, 2.5 X 8 MM PROMUS (LOT 8050261), 3.0 X 15 MM PROMUS (LOT 8042861), ARE BEING FILED UNDER THE SAME MFR#.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: STENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL, THAT WHEN THE PATIENT WAS SEEN AT THE SIX MONTH FOLLOW UP, TOTAL STENOSIS WAS FOUND AT THE PROMUS STENTS. TOTAL VESSEL REVASCULARIZATION WAS PERFORMED, AND NO OTHER PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION 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 8081161

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention STENT: 2.5 X 8 MM PROMUS| LOT 8050261)| 3.0 X 15 MM PROMUS (LOT 8042861)