BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1800911 · Received August 10, 2010

    Report

    Report Number
    2024168-2010-01636
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 16, 2010
    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

    (B)(4). RESTENOSIS IS A KNOWN ADVERSE EVENT AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE (IFU). SINCE IT WAS REPORTED THAT THE PROMUS STENT WAS IMPLANTED IN A SAPHENOUS VEIN GRAFT (SVG), IT SHOULD BE NOTED THAT THE PROMUS IFU STATES: THE PROMUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (PROMUS STENT) IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH LESS THAN OR EQUAL TO 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 4.25 MM. THE IFU CAUTIONS THAT: SAFETY AND EFFECTIVENESS OF THE PROMUS STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH LESIONS LOCATED IN SAPHENOUS VEIN GRAFTS. IN THIS CASE, IT CANNOT BE DETERMINED WHETHER THE IFU DEVIATION CONTRIBUTED TO THE REPORTED PATIENT EFFECTS.

    Description of Event or Problem · 1

    ADVERSE EVENT: IN STENT RESTENOSIS REQUIRING MEDICAL INTERVENTION. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. DEVICE ISSUE: NONE. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT IN STENT RESTENOSIS (ISR) OF A PROMUS 3.0 X 18 MM STENT THAT WAS DEPLOYED IN A SAPHENOUS VEIN GRAFT TO THE CIRCUMFLEX. THE FIRST ATTEMPT TO CROSS THE XIENCE 2.5 X 08 MM STENT WAS DIRECT STENTING AND THE DEVICE WOULD NOT CROSS THE ISR. THEN PRE-DILATION WAS PERFORMED AND A SECOND XIENCE 2.5 X 08 MM WAS ADVANCED, BUT ALSO DID NOT CROSS THE ISR. AFTER MORE PRE-DILATION, A XIENCE 3.0 X 18 MM WAS ABLE TO CROSS AND WAS DEPLOYED TO TREAT THE ISR. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES A 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 85 YR Required Intervention