BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERGREEN PTCA CATHETER

    MDR report key: 117916 · Received September 4, 1997

    Report

    Report Number
    2083093-1997-00038
    Event Type
    Injury
    Date Received
    September 4, 1997
    Date of Event
    July 28, 1997
    Report Date
    August 21, 1997
    Manufacturer
    MEDTRONIC INTERVENTIONAL VASCULAR, INC.
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING PRE-DILATATION PRIOR TO STENT PLACEMENT A DISSECTION WAS OBSERVED. A WIKTOR STENT WAS IMPLANTED IN THE TARGET LESION SUCCESSFULLY AND A GR2 STENT WAS IMPLANTED DISTAL TO THE WIKTOR STENT TO ADDRESS THE DISSECTION. VESSEL DISSECTION IS A KNOWN POTENTIAL ADVERSE EFFECT OF CORONARY ANGIOPLASTY. NO PRODUCT PERFORMANCE ISSUES OR PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVERGREEN PTCA CATHETER CORONARY BALLOON ANGIOPLASTY CATHETER LOX MEDTRONIC INTERVENTIONAL VASCULAR, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention WIKTOR STENT, GR2 STENT.