BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM REGENT HEART VALVE W/FLEX CUFF

    MDR report key: 7044925 · Received November 20, 2017

    Report

    Report Number
    2648612-2017-00097
    Event Type
    Death
    Date Received
    November 20, 2017
    Report Date
    February 19, 2018
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: AN EVENT OF PATIENT DEATH WAS REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6), A 25MM MASTER SERIES VALVE WAS TO BE IMPLANTED DUE TO A SEVERE CASE OF AORTIC ENDOCARDITIS. THE PHYSICIAN PERFORMED AN AORTOTOMY, AND THEN A BENTALL PROCEDURE WAS GOING TO BE PERFORMED. INITIAL SIZING WAS FOR A 25MM MASTERS SERIES VALVE; HOWEVER, AFTER OPENING THE PACKAGE AND FURTHER ANALYSIS, A 23MM REGENT MECHANICAL VALVE WAS IMPLANTED SUCCESSFULLY. FOUR HOURS AFTER THE OPERATION, THE PATIENT DIED DUE TO FACTORS THAT ARE NOT VALVE RELATED.

    Description of Event or Problem · 1

    ON 06 OCTOBER 2017, A 25MM MASTER SERIES MECHANICAL VALVE WAS SELECTED FOR IMPLANT AS THE REPLACEMENT VALVE FOR A 27MM REGENT AORTIC VALVE THAT HAD BEEN IMPLANTED AT AN UNREPORTED DATE. INFORMATION FROM (B)(6) PDT DOES SHOW THIS PATIENT HAD AN IMPLANT ON (B)(6) 2007 AND ADDITIONAL DETAILS INCLUDING IMPLANT CONFIRMATION IS REQUESTED. IT WAS REPORTED THE REDO PROCEDURE WAS REQUIRED DUE TO A HISTORY OF SEVERE ENDOCARDITIS. AFTER OPENING THE AORTOTOMY, THE PHYSICIAN ANTICIPATED PERFORMING A BENTALL PROCEDURE. INITIAL SIZING INDICATED A 25MM VALVE WOULD BE REQUIRED AND THE USER SELECTED A 25MM MASTERS VAVGJ. FOLLOWING THE COMPLETE INSPECTION OF THE AORTA AND ANNULUS, THE USER ELECTED TO USE A 23MM REGENT MECHANICAL VALVE INSTEAD. THE 25MM MASTERS VAVGJ WAS NOT USED AND THERE WAS NO PATIENT CONTACT. THE 23MM REGENT VALVE WAS SUCCESSFULLY IMPLANTED AND PER REPORT THE PHYSICIAN STATED THE IMPLANT WAS TECHNICALLY DIFFICULT DUE TO THE ENDOCARDITIS. THE PATIENT EXPIRED FOUR HOURS AFTER THE PROCEDURE IN THE ICU. PER REPORT THE CAUSE OF DEATH WAS NOT VALVE RELATED BUT PATIENT FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826176 SJM REGENT HEART VALVE W/FLEX CUFF HEART-VALVE, MECHANICAL LWQ ST. JUDE MEDICAL PUERTO RICO, INC. 23AGFN-756

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death