BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMPLATZER DUCT OCCLUDER

    MDR report key: 729406 · Received June 23, 2006

    Report

    Report Number
    2135147-2006-00044
    Event Type
    Other
    Date Received
    June 23, 2006
    Date of Event
    May 9, 2006
    Report Date
    June 23, 2006
    Manufacturer
    AGA MEDICAL CORP.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LARGE 4MM TUBULAR PDA, SIGNIFICANT BRADYCARDIA WHEN 7F DELIVERY ADO SHEATH CROSSED PDA ANTEGRADE. MULTIPLE MANIPULATIONS STABLIZED PT AND 8/6 DEVICE PALCED. ADVANCEMENT APPEARED SUBOPTIMAL, BRADYCARDIA AND HYPOTENSION RE-OCCURRED SO DEVICE REMOVED. AFTER 8/6 DEVICE REMOVED, A 6/4 PLACED WITHOUT BRADYCARDIA OR HYPOTENSION AND APPEARED IN GOOD POSITION. HOWEVER, WHEN ANGIOGRAM DONE 10 MINS LATER, THERE WAS NO FLOW TO THE LPA, AND PROXIMAL PINCHING OF RPA WITH SLUGGISH FLOW OCCURRED. PT AGAIN HAD HYPOTENSION AND BRADYCARDIA. DEVICE REMOVED AND PT REFERRED FOR SURGERY. THERE WAS NO PT INJURY AND MED INTERVENTION WAS NOT REQUIRED. BOTH DEVICES WERE STILL ATTACHED TO THE CABLE WHEN REMOVED FROM PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER DUCT OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORP. 9-PDA-004 M06A31-01

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Other A 7F DELIVERY SYSTEM (MFR UNK)