BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIR STENT 2 IN 1 W/BALLOON 16MMX3MM

    MDR report key: 219996 · Received April 19, 1999

    Report

    Report Number
    219996
    Event Type
    Injury
    Date Received
    April 19, 1999
    Date of Event
    March 4, 1999
    Report Date
    March 25, 1999
    Manufacturer
    SCI-MED LIFE SYSTEMS, INC.
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED FOR ANGIOPLASTY OF THE LEFT ANTERIOR DESCENDING ARTERY. ON 3/3/99, PT WAS IN CATH LAB TO HAVE AN ANGIOPLASTY WITH STENT PLACEMENT. THE ANGIOPLASTY BALLOON WAS BEING INFLATED AS ORDERED BY THE PHYSICIAN PER THE SCRUB NURSE. APPROXIMATELY, 15-20 SECS INTO INFLATING THE ANGIOPLASTY BALLOON, THE PHYSICIAN ORDERED THE SCRUB NURSE TO DEFLATE THE ANGIOPLASTY BALLOON. AT THIS TIME THE PHYSICIAN SAW THE LEFT MAIN ARTERY HAD DISSECTED SECONDARY TO RUPTURE OF THE ANGIOPLASTY BALLOON. THIS WAS LATER CONFIRMED AFTER THE PHYSICIAN REVIEWED THE FILM. THE BALLOON WAS REMOVED BUT THE CATHETER WAS LEFT IN PLACE TO KEEP THE ARTERY PATENT. A CARDIOTHORACIC SURGEON WAS CALLED TO EVALUATE THE PT AND IT WAS DECIDED TO TRANSPORT THE PT FOR EMERGENCY OPEN HEART SURGERY. CABG X2 WAS PERFORMED WITHOUT COMPLICATIONS AND THERE WAS NO NOTE OF FRAGMENTS IN THE LEFT MAIN ARTERY. HOSP COURSE WAS UNEVENTFUL AND THE PT WAS DISCHARGED HOME ON 3/12/99.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIR STENT 2 IN 1 W/BALLOON 16MMX3MM Implant * MAF SCI-MED LIFE SYSTEMS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R