BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT VISION

    MDR report key: 621778 · Received July 13, 2005

    Report

    Report Number
    621778
    Event Type
    Malfunction
    Date Received
    July 13, 2005
    Date of Event
    July 11, 2005
    Report Date
    July 12, 2005
    Manufacturer
    GUIDANT CORPORATION
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2005 STENTS CAME OFF BALLOON DURING PTCA OF THE RIGHT CORONARY ARTERY. REQUIRED A DIFFERENT BALLOON TO DEPLOY REQUIRED MULTIPLE STENTS DUE TO DIFFICULTY GETTING STENTS TO GO TO DESIRED LOCATION. NO ADVERSE OUTCOME TO PT. (THREE STENTS (1) ML VISION 3.0 X 18 MM) REF 1007848-18, LOT# 5051331. (2) MULTI LINK VISION 3.0 X 12 MM REF 1007848-12, LOT# 4071931. (3) M-L VISION 3.0 X 12 MM REF 1007848-12, LOT#5052331.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT VISION M-L VISION STENT MAF GUIDANT CORPORATION 3.0 X 18 MM, 3.0 X 12 MM 5051331,4071931, 5052331

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other