BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MASTERS SERIES MECHANICAL HEART VALVE

    MDR report key: 5773258 · Received July 6, 2016

    Report

    Report Number
    2648612-2016-00065
    Event Type
    Injury
    Date Received
    July 6, 2016
    Report Date
    June 28, 2016
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GTIN -- UNKNOWN, LOT NUMBER NOT PROVIDED. 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.

    Description of Event or Problem · 1

    ACCORDING TO THE ARTICLE "SPONTANEOUS CLOSURE OF A LARGE LEFT VENTRICULAR PSEUDOANEURYSM AFTER MITRAL VALVE REPLACEMENT" (DOI 10.1007/S11748-014-0474-Y), IT WAS SUGGESTED THAT PSEUDOANEURYSMS GENERALLY OCCUR AS A COMPLICATION OF A MYOCARDIAL INFARCTION, INFECTIVE ENDOCARDITIS OR CARDIAC SURGERY. IN ONE CASE, A PATIENT REPORTED WITH A LARGE, LEFT VENTRICULAR PSEUDOANEURYSM POST-MITRAL VALVE REPLACEMENT (MVR) WITH A 29MM SJM MASTERS SERIES MECHANICAL HEART VALVE FOR RHEUMATIC MITRAL VALVE STENOSIS. THE PATIENT'S INITIAL POST-OPERATIVE COURSE WAS UNEVENTFUL; HOWEVER, TESTS SHOWED AN ABNORMAL POUCH WITH INCOMING BLOOD FLOW ON THE POSTEROMEDIAL WALL OF THE LEFT VENTRICLE AND A 30 X 42MM PSEUDOANEURYSM WAS DIAGNOSED. THE PATIENT OPTED FOR WARFARIN THERAPY IN LIEU OF SURGICAL REPAIR AND REMAINED ASYMPTOMATIC. TWO YEARS POST-MVR, REPEAT TESTS SHOWED SPONTANEOUS CLOSURE OF THE PSEUDOANEURYSMAL NECK WHICH WAS ATTRIBUTED TO ITS NARROW NECK (4MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425185 SJM MASTERS SERIES MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ ST. JUDE MEDICAL PUERTO RICO, INC. 29MJ-501

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention