BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1163093 · Received September 16, 2008

    Report

    Report Number
    2024168-2008-00805
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DISSECTION, AS LISTED IN THE INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NO LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. IT SHOULD BE NOTED THAT THE IFU ALSO STATES, "IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADDITIONAL STENTS, OR OTHER)." IT SHOULD ALSO BE NOTED THAT THE PROMUS IFU STATES, "PRE-DILATE THE LESION WITH A PTCA CATHETER." IN THIS CASE, IT IS POSSIBLE THAT THE DIRECT STENTING MAY HAVE CONTRIBUTED TO THE DISSECTION.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED THAT VIA A TRAIL, THE TARGET LESION WAS A DE NOVO, WITH MILD CALCIFICATION AND A 80% STENOSIS. THE LESION WAS NOT PREDILATED. THE 3.5 X 18 MM PROMUS STENT WAS IMPLANTED; HOWEVER, A DISSECTION OCCURRED PROXIMAL TO THE TARGET LESION. A 3.5. X 8 MM PROMUS STENT WAS DEPLOYED PROXIMAL TO THE FIRST STENT AND OVERLAPPING, TREATING THE DISSECTION. RESIDUAL STENOSIS WAS 0%. THE PT WAS DISCHARGED IN 2008, WITH NO REPORTED EVENTS. 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 8051241

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention