BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTEGRA PULMONARY VALVED CONDUIT

    MDR report key: 1745718 · Received June 28, 2010

    Report

    Report Number
    2025587-2010-00063
    Event Type
    Death
    Date Received
    June 28, 2010
    Date of Event
    May 14, 2010
    Report Date
    June 3, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: OTHER = DEVICE HISTORY REVIEWED. RESULTS: OTHER = DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: OTHER = CAUSE OF EVENT RELATED TO INTRACRANIAL BLEED. ANALYSIS: NO PRODUCT WAS RETURNED FOR ANALYSIS. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THE VALVE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. BASED ON THE PHYSICIAN'S REPORT, THE DEATH WAS PRECIPITATED BY BILATERAL INTRACRANIAL HEMORRHAGE WITH HYDROCEPHALUS, SECONDARY TO TPA TREATMENT.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THE PT WITH THIS PULMONARY VALVED CONDUIT, IMPLANTED 2.5 YEARS, DIED. IT WAS REPORTED THAT THE PT PRESENTED FOR OUTPATIENT CARDIAC CATHETERIZATION DUE TO CONDUIT AND BRANCH PA STENOSIS. CATHETERIZATION WAS PERFORMED AND AT INITIATION OF THE CASE, THE PT WAS NOTED TO HAVE METABOLIC ACIDOSIS. SEVERE RV-PA CONDUIT OBSTRUCTION WAS NOTED ON ANGIOGRAPHY DUE TO THROMBUS. PRIOR TO ANY INTERVENTION, THE PT ACUTELY DECOMPENSATED WITH HYPOTENSION, DESATURATION, AND BRADYCARDIA. CPR WAS INITIATED AND DURING THE RESUSCITATION, A PREMOUNTED STENT WAS EMERGENTLY PLACED ACROSS THE RV-PA CONDUIT WITH IMMEDIATE IMPROVEMENT IN HEMODYNAMIC PARAMETERS. AT TRANSFER TO THE CICU, ECHO REVEALED DECREASED RV FUNCTION, THROMBI IN THE STENT, AS WELL AS A LARGE ECHOBRIGHT DENSITY SEEN AT THE LEVEL OF THE PULMONARY ARTERY BRANCH BIFURCATION. MILRINONE WAS INITIATED, HOWEVER, ANTICOAGULATION WAS HELD DUE TO RISK FOR BLEEDING. THE PT CLINICALLY IMPROVED AND WAS WEANED FROM THE VENTILATOR. THE NEXT DAY, THE DECISION WAS MADE TO INITIATE SYSTEMIC TPA DUE TO THE RISK WITH THE RESIDUAL THROMBUS INVOLVING THE PA BIFURCATION. CT SCAN OF THE BRAIN PRIOR TO INITIATION OF TPA WAS NORMAL. THE PT WAS STARTED ON THE RECOMMENDED INITIATION DOSE AND FOLLOWED CLOSELY. AT 6 HOURS POST TPA INITIATION, THE PT WAS NOTED TO HAVE AN ACUTE MENTAL STATUS CHANGE. THE TPA WAS STOPPED AND THE PT WAS INTUBATED FOR AIRWAY PROTECTION. CT SCAN CONFIRMED LARGE BILATERAL INTRACRANIAL HEMORRHAGE WITH HYDROCEPHALUS. AN EXTERNAL VENTRICULAR DRAIN (EVD) WAS PLACED AND THE PT WAS TRANSFERRED TO PICU FOR ONGOING CARE. AFTER TRANSFER TO THE PICU, PERSISTENT INTRACRANIAL BLEEDING CONTINUED DESPITE AGGRESSIVE MEDICAL MANAGEMENT. THE FAMILY DECIDED TO WITHDRAW SUPPORT AND THE PT EXPIRED SHORTLY THEREAFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTEGRA PULMONARY VALVED CONDUIT MWH MEDTRONIC HEART VALVES, INC. 200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Death