BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1456816 · Received August 27, 2009

    Report

    Report Number
    2024168-2009-01562
    Event Type
    Injury
    Date Received
    August 27, 2009
    Date of Event
    May 6, 2009
    Report Date
    August 4, 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

    MI, STENOSIS AND THROMBOSIS, AS LISTED IN THE XIENCE V IFU, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURE. THESE KNOWN PT EFFECTS ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. ADDITIONALLY, THERE WAS NO REPORT OF ANY PRODUCT MALFUNCTION IDENTIFIED DURING THE PROCEDURE THAT COULD HAVE CONTRIBUTED TO THE REPORTED PT EFFECTS. ALTHOUGH THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, A DEFINITIVE CAUSE FOR THE REPORTED PT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE SECOND PROMUS (PART 1009529-12B, LOT 8042161), IS BEING FILED UNDER THE SAME MFR#.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION/PERMANENT DAMAGE. REPORTING RATIONALE: STENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL, THAT THE 3.0 X 15 MM AND 3.0 X 12 MM PROMUS STENTS WERE IMPLANTED IN 2008. DURING FOLLOW-UP, THE PT WAS DIAGNOSED WITH IN-STENT RESTENOSIS AND THROMBOSIS, AND HAD EXPERIENCED AN MI. TOTAL VESSEL REVASCULARIZATION WAS PERFORMED IN 2009. 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 8042861

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R| S STENT: 3.0 X 12 MM PROMUS (PART 1009529-012B| LOT 8042161)