BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGA CLIP EXTRA LIGATING CLIP

    MDR report key: 553908 · Received November 9, 2004

    Report

    Report Number
    553908
    Event Type
    Death
    Date Received
    November 9, 2004
    Date of Event
    June 11, 2004
    Report Date
    November 3, 2004
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT AN OFF-PUMP 3 VESSEL CORONARY ARTERY BYPASS GRAFT PROCEDURE (CABG) IN 2004 AFTER RULING IN FOR MYOCARDIAL INFARCTION BY ENZYMES. THE PATIENT HAD UNDERGONE CARDIAC CATHETERIZATION AT AN OUTSIDE HOSPITAL AND TRANSFERRED FOR FURTHER EVALUATION. NO COMPLICATIONS DURING THE PROCEDURE WERE REPORTED AND THE PATIENT WAS TRANSFERRED TO THE CARDIAC SURGERY INTENSIVE CARE UNIT (ICU) POST OPERATIVELY. SOON AFTER ARRIVAL IN THE ICU, THE PATIENT BECAME ACUTELY HYPOTENSIVE AND WAS NOTED TO HAVE APPROXIMATELY 600 CC OF BLOOD FROM CHEST TUBES. CARDIOVASCULAR RESUSCITATION WAS INITIATED IMMEDIATELY. AN ATTEMPT AT PACING IN THE ICU WAS NOT SUCCESSFUL. THE PATIENT'S CHEST WAS OPENED IN THE ICU AND OPEN CARDIAC MASSAGE WAS PERFORMED. BLOOD WAS NOTED IN THE PERICARDIUM. THE PATIENT WAS TAKEN EMERGENTLY TO THE OR AND PLACED ON CARDIOPULMONARY BYPASS. A CARDIAC RHYTHM WAS ESTABLISHED. BLEEDING WAS NOTED FROM A SIDE BRANCH OF THE RIGHT CORONARY ARTERY THAT HAD BEEN CLIPPED DURING THE CABG FOR PURPOSES OF VEIN GRAFT HARVESTING. BOTH CLIPS WERE NOTED TO HAVE FALLEN OFF. THE ARTERY WAS RE-CLIPPED AND THE PATIENT STABILIZED AND RETURNED TO THE ICU. THE FOLLOWING DAY, THE PATIENT WAS NOTED TO BE UNRESPONSIVE. A HEAD CT SCAN REVEALED MULTIPLE WATERSHED INFARCTS CONSISTENT WITH SEVERE ANOXIC ENCEPHALOPATHY. NEUROLOGY CONSULTATION CONFIRMED A POOR NEUROLOGIC PROGNOSIS. AT THE FAMILY'S REQUEST, THE PATIENT WAS TRANSFERRED TO A HOSPITAL CLOSER TO HOME WHERE TREATMENT WAS WITHDRAWN AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGA CLIP EXTRA LIGATING CLIP TITANIUM CLIP GDO ETHICON ENDO-SURGERY, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death NO OTHER THERAPIES