BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN MECHANICAL HEART VALVE

    MDR report key: 18915319 · Received March 15, 2024

    Report

    Report Number
    2135147-2024-01146
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    April 1, 1990
    Report Date
    April 4, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT RETURNING FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. LITERATURE ATTACHMENT: ARTICLE TITLE "BENEFITS OF ON-X MITRAL VALVE REPLACEMENT IN CASES OF INFECTIVE ENDOCARDITIS".

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF MECHANICAL HEART VALVE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HYPERTENSION, DYSLIPIDEMIA, DIABETES MELLITUS, RENAL DYSFUNCTION, CHRONIC OBSTRUCTIVE PULMONARY DISORDER, ATRIAL FIBRILLATION AND PREVIOUS CARDIAC SURGERY. SOME OF THE COMPLICATIONS REPORTED WERE SURGICAL INTERVENTION, HOSPITALIZATION, MITRAL REGURGITATION, ATRIAL FIBRILLATION, PARAVALVULAR LEAK, INFECTIVE ENDOCARDITIS, INTRACRANIAL HEMORRHAGE, STROKE, HEART FAILURE, CARDIAC ARREST, ARRHYTHMIA AND PATIENT DEATH. IT WAS REPORTED THAT PATIENT DEATH IN THE SJM GROUP WAS DUE TO INTRACRANIAL HEMORRHAGE, STROKE, CONGESTIVE HEART FAILURE, SUDDEN CARDIAC ARREST DUE TO VENTRICULAR ARRHYTHMIA, OR WAS SUDDEN AND OF UNKNOWN CAUSE. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 0

    THE ARTICLE, "BENEFITS OF ON-X MITRAL VALVE REPLACEMENT IN CASES OF INFECTIVE ENDOCARDITIS", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY INVESTIGATED THE HEMODYNAMIC EFFICACY OF THE ON-X VALVE WHEN USED FOR MITRAL VALVE REPLACEMENT (MVR) IN CASES OF MITRAL VALVE INFECTIVE ENDOCARDITIS (IE). DEVICES INCLUDED IN THIS STUDY WERE ON-X (ON-X LIFE TECHNOLOGIES INC.) AND UNKNOWN SJM MECHANICAL HEART VALVE (ST JUDE MEDICAL/ABBOTT). THE ARTICLE CONCLUDED THAT THE SUGGESTED REDUCTION IN LEFT ATRIAL LOAD ATTRIBUTED TO THE USE OF THE ON-X VALVE IN MVR FOR IE MAY REDUCE THE INCIDENCE OF POSTOPERATIVE ATRIAL FIBRILLATION. [THE PRIMARY AND CORRESPONDING AUTHOR WAS MANABU SHIRAISHI, DEPARTMENT OF CARDIOVASCULAR SURGERY, SAITAMA MEDICAL CENTER, JICHI MEDICAL UNIVERSITY, SAITAMA, JAPAN, WITH CORRESPONDING EMAIL: (B)(6) ] THE TIME FRAME OF THE STUDY WAS FROM APRIL 1990 AND DECEMBER 2022. A TOTAL OF (B)(6) PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH 27 (67.5%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 54.1 YEARS AND THE GENDER MAJORITY WAS MALE. COMORBIDITIES INCLUDED HYPERTENSION, DYSLIPIDEMIA, DIABETES MELLITUS, RENAL DYSFUNCTION, CHRONIC OBSTRUCTIVE PULMONARY DISORDER, ATRIAL FIBRILLATION, PREVIOUS CARDIAC SURGERY, INFECTIVE ENDOCARDITIS, HEART FAILURE, UNCONTROLLED SEPSIS, SYSTEMIC EMBOLIC EVENT, MOBILE VEGETATION, SEVERE MITRAL REGURGITATION. PERI- AND POST-PROCEDURAL COMPLICATIONS INCLUDED DEATH, SURGICAL INTERVENTION, HOSPITALIZATION, MITRAL REGURGITATION, ATRIAL FIBRILLATION, PARAVALVULAR LEAK, INFECTIVE ENDOCARDITIS, INTRACRANIAL HEMORRHAGE, STROKE, HEART FAILURE, CARDIAC ARREST, ARRHYTHMIA "DEATH IN THE SJM GROUP WAS DUE TO INTRACRANIAL HEMORRHAGE (N=1), STROKE (N=1), CONGESTIVE HEART FAILURE (N=2), SUDDEN CARDIAC ARREST DUE TO VENTRICULAR ARRHYTHMIA (N=1), OR WAS SUDDEN AND OF UNKNOWN CAUSE (N=1)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875607 UNKNOWN MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| D| S| R| H