BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT

    MDR report key: 21157 · Received April 3, 1995

    Report

    Report Number
    21157
    Event Type
    Injury
    Date Received
    April 3, 1995
    Date of Event
    March 23, 1995
    Report Date
    March 24, 1995
    Manufacturer
    CARDIOVASCULAR IMAGING SYSTEMS, INC.
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT FOR STENT PLACEMENT RCA (3) 4.0 COOK STENTS PLACED SIDE BY SIDE IN RCA AND DEPLOYED. BALLOON CATHETER PLACED TO POST DILATE STENTS AND IMBED. BALLOON CATHETER CAUGHT UP IN 2ND STENT AND STENT ACCORDIONED. 3.5 J&J STENT PLACED IN ACCORDIONED STENT FOR SUPPORT. DISTAL DISSECTION NOTED. 4.0 J&J STENT PLACED AT SITE OF DISSECTION. 3.2 MICRORAIL PASSED TO CHECK DISSECTION. MICRORAIL CAUGHT IN 2ND STENT AND CATHETER TIP BROKE OFF. PT TAKEN TO SURGERY FOR BYPASS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STENT Implant STENT MAF CARDIOVASCULAR IMAGING SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 25 DAY Hospitalization| O| R