BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1241719 · Received November 20, 2008

    Report

    Report Number
    2024168-2008-01192
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 21, 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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - VESSEL OCCLUSION IS A KNOWN OUTCOME OF CORONARY STENTING PROCEDURES AND IS LISTED IN THE DEVICE INSTRUCTIONS FOR USE (IFU) AS A POTENTIAL ADVERSE EVENT. POSSIBLY THE POSITION OF THE STENT IMPLANT IN THE FIRST DIAGONAL CONTRIBUTED TO OCCLUDING THE SIDE BRANCH, THOUGH THIS COULD NOT BE CONFIRMED. A DEFINITE ROOT CAUSE FOR THE OCCLUSION AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. REPORTEDLY, NO PRE-DILATATION WAS PERFORMED PRIOR TO THE USE OF THE PROMUS SDS. THE IFU INSTRUCTS: "PRE-DILATE THE LESION WITH A PTCA CATHETER." IN THIS CASE, IT IS NOT KNOWN HOW NOT PRE-DILATING THE LESION MAY HAVE CONTRIBUTED TO THE SIDE BRANCH OCCLUSION.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/PERMANENT DAMAGE. REPORTING RATIONALE: OCCLUSION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT IN 2008, THE PROMUS STENT WAS IMPLANTED TO TREAT A DE NOVO, MILDLY TORTUOUS, 80% STENOSED LESION IN THE 1ST DIAGONAL. PREDILATATION WAS NOT PERFORMED, RESULTING IN 0% RESIDUAL STENOSIS; HOWEVER, SIDE BRANCH FLOW IMPAIRMENT WAS NOTED POST TREATMENT. THE PATIENT WAS DISCHARGED ON THE NEXT DAY. 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 7110561

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability