BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSEAL CS-23-QL-VSD

    MDR report key: 373938 · Received January 25, 2002

    Report

    Report Number
    1222632-2001-00019
    Event Type
    Injury
    Date Received
    January 25, 2002
    Date of Event
    December 19, 2001
    Report Date
    January 22, 2002
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO NMT BY DR.: "IN 2001, A 23MM DEVICE WAS PLACED IN A POST-OP INFERIOR RIM MEMBRANOUS RESIDUAL VSD. THE VSD MEASURED 8 MM BY BALLOON STRETCH, SOMEWHAT LESS BY TEE. THE PROCEDURE WAS UNCOMPLICATED. POST IMPLANT ECHO SHOWED GOOD DEVICE POSITION. THE QP/QS DECREASED FROM 3:1 TO 1:3:1. A CXR THE NEXT MORNING SHOWED THE DEVICE TO BE IN GOOD POSITION. PATIENT WAS SEEN ON FOLLOW-UP 3 MONTHS LATER. PATIENT GAVE A THREE WEEK HISTORY OF RECURRENCES OF SYMPTOMS (FATIGUE) AND RETURN OF A RATTLING MURMUR IN THE CHEST. ON CLINIC VISIT, THE MURMUR WAS LOUD AND A CXR SHOWED THE DEVICE IN THE PROXIMAL LEFT LOWER LUNG PULMONARY ARTERY. PATIENT UNDERWENT UNEVENTFUL SURGICAL REMOVAL OF THE DEVICE, CLOSURE OF THE "VSD" AND A "PFO", AND WENT HOME 4 DAYS LATER. THE SURGEON DESCRIBED THAT THE "VSD" HAD A BAND OF TISSUE THROUGH THE CENTER AND THAT THE TOTAL "VSD" DIAMETER WAS CLOSER TO 15 MM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL CS-23-QL-VSD CARDIOSEAL MLV NMT MEDICAL, INC. CS-23-QL-VSD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention NI.