BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 4633453 · Received March 25, 2015

    Report

    Report Number
    2025587-2015-00363
    Event Type
    Death
    Date Received
    March 25, 2015
    Date of Event
    February 12, 2015
    Report Date
    April 24, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF DEATH WAS NOT REPORTED; AN ESTIMATED DATE OF JAN 1, 2000 WAS CHOSEN AS THE EARLIEST POSSIBLE DATE OF DEATH WITHIN THE STUDY TIME FRAME. THE DEVICES WERE NOT RETURNED TO MEDTRONIC. (B)(4). TITLE: HEMODYNAMIC PERFORMANCE AND DURABILITY OF MOSAIC BIOPROSTHESES FOR AORTIC VALVE REPLACEMENT, UP TO 13 YEARS AUTHORS: YORIHIKO MATSUMOTO, MD; TOMOYUKI FUJITA, MD, PHD; HIROKI HATA, MD, PHD; YUSUKE SHIMAHARA, MD; SHUNSUKE SATO, MD; JUNJIRO KOBAYASHI, MD, PHD DOI: 10.1253/CIRCJ.CJ-14-0990.

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION(S). WITHOUT PRODUCT SERIAL NUMBER(S) NO DEVICE HISTORY RECORDS COULD BE PULLED FOR REVIEW.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REVEALED THE PHYSICIAN STATED THE OBSERVED ADVERSE EVENTS WERE NOT CAUSED OR CONTRIBUTED TO BY THE DEVICES. ALSO, THE SPECIFIC MODEL/SERIAL INFORMATION WAS NOT DISCLOSED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT A RETROSPECTIVE STUDY OF 207 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE OF 74 YEARS) WAS PERFORMED TO EVALUATE THE MID TO LONG-TERM DURABILITY AND HEMODYNAMICS OF A SMALL-SIZE BIOPROSTHETIC STENTED PORCINE AORTIC VALVE AS COMPARED TO LARGER SIZES. A 19-MM, 21-MM, 23-MM, 25-MM, AND 27-MM PROSTHESIS WAS IMPLANTED IN 103, 53, 35, 13, AND 3 PATIENTS, RESPECTIVELY. THE STUDY ASSESSED PATIENTS BETWEEN THE YEARS 2000 TO 2012, WITH A MEAN FOLLOW-UP OF 3.5 YEARS. THE 30-DAY MORTALITY RATE WAS 1.9%, WHICH INCLUDED DEATHS DUE TO LEFT VENTRICLE RUPTURE (N=2), LOW OUTPUT SYNDROME (N=2), AND MEDIASTINITIS (N=1). THERE WERE 22 LATE DEATHS, 5 OF WHICH WERE FROM CARDIAC CONDITIONS: HEART FAILURE (N=2), SUDDEN DEATH (N=2), ENDOCARDITIS (N=1), AND CEREBRAL BLEEDING (N=1). OTHER ADVERSE PATIENT EFFECTS INCLUDED CHRONIC HEART FAILURE (N=5), IMPLANT OF A PERMANENT PACEMAKER (N=5) AND CEREBRAL INFARCTION/BLEEDING (N=4). VALVE-RELATED COMORBIDITIES OCCURRED IN 3 PATIENTS: STRUCTURAL VALVE DETERIORATION (SVD) NOTED AS LEAFLET DEGRADATION REQUIRING REOPERATION AT 7.2 YEARS (N=1), AND ENDOCARDITIS (N=2). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200489 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE TIMER, CLOT, AUTOMATED LWR MEDTRONIC HEART VALVES DIVISION 30525

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death| L| R