BEUDAMED
    FDA Adverse Event Death Summary report: N

    REGENT MECHANICAL HEART VALVE

    MDR report key: 6128440 · Received November 28, 2016

    Report

    Report Number
    2648612-2016-00119
    Event Type
    Death
    Date Received
    November 28, 2016
    Date of Event
    April 14, 2016
    Report Date
    November 4, 2016
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PLEASE REFER TO MDR-2016-31102 FOR A RELATED REPORT FOR THE 19MM TRIFECTA VALVE. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE SERIAL NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). PLEASE REFER TO MDR-(B)(4) FOR A RELATED REPORT FOR THE TRIFECTA VALVE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A 19MM TRIFECTA VALVE WAS IMPLANTED (B)(4). ON (B)(6) 2016, THE PATIENT UNDERWENT A REDO AORTIC VALVE REPLACEMENT SECONDARY TO STENOSIS AND PATIENT-PROSTHESIS MISMATCH. THE TRIFECTA VALVE WAS EXPLANTED AND A 21MM REGENT VALVE WAS IMPLANTED (SN UNKNOWN). ON (B)(6) 2016, THE PATIENT DIED SECONDARY TO ACUTE RESPIRATORY FAILURE, HEMORRHAGIC SHOCK, AND MULTI-VISCERAL FAILURE. (CLINICAL STUDY PATIENT ID: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE PATIENT REQUIRED EMERGENT REDO AVR SECONDARY TO STENOSIS AND PATIENT-PROSTHESIS MISMATCH. THE EMERGENT SURGERY WAS NOT PERFORMED BY THE STUDY INVESTIGATOR AND WHAT WAS REPORTED TO POSTMARKET SURVEILLANCE WAS: THE TRIFECTA VALVE WAS EXPLANTED AND THE AORTIC ANNULUS WAS ENLARGED BY NICKS TECHNIQUE. AS THE PATIENT HAD A FRAGILE AORTA, A BOVINE PERICARDIAL PATCH WAS PLACED AND EXTENDED FROM THE MITRAL LEAFLET TO THE AORTIC NON-CORONARY SINUS AND A 21MM REGENT VALVE (SN UNKNOWN) WAS IMPLANTED IN THE AORTIC POSITION. CONCOMITANTLY, DUE TO WORSENING MITRAL REGURGITATION, THE PATIENT UNDERWENT A MITRAL VALVULOPLASTY USING A MEDTRONIC FUTURE BAND, AND PER REPORT THIS WAS UNSUCCESSFUL DUE TO THE PRESENCE OF THE AORTIC RECONSTRUCTION. THE SURGEON THEN ELECTED TO IMPLANT A 27MM SJM MECHANICAL VALVE IN THE MITRAL ANNULUS. PER REPORT, THE TOTAL CARDIOPULMONARY BYPASS (CPB) TIME WAS 308 MINUTES; THE TOTAL AORTIC CROSS-CLAMP TIME WAS 232 MINUTES. THE PATIENT WAS WEANED FROM CPB USING LOW DOSE INOTROPES AND TRANSFERRED TO THE ICU. AFTER EXTUBATION, THE PATIENT REQUIRED REINTUBATION DUE TO WORSENING RESPIRATORY CONDITION WITH PLEURAL EFFUSION AND SLOW NEUROLOGICAL AWAKENING. ON 26 APRIL 2016, THE PATIENT DEVELOPED ACUTE RESPIRATORY DISTRESS SECONDARY TO A RIGHT HEMOTHORAX AND WORSENING PLEURAL EFFUSION POST-SURGERY. ON 28 APRIL 2016, THE PATIENT DIED SECONDARY TO ACUTE RESPIRATORY FAILURE, HEMORRHAGIC SHOCK, AND MULTI-VISCERAL ORGAN FAILURE. (CLINICAL STUDY PATIENT ID: FRLIM01-1016)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779359 REGENT MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ ST. JUDE MEDICAL PUERTO RICO, INC. 21AGFN-756

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death