BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 5583484 · Received April 17, 2016

    Report

    Report Number
    2025587-2016-00529
    Event Type
    Injury
    Date Received
    April 17, 2016
    Date of Event
    February 1, 2014
    Report Date
    March 21, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: CAN POSTOPERATIVE MEAN TRANSPROSTHETIC PRESSURE GRADIENT PREDICT SURVIVAL AFTER AORTIC VALVE REPLACEMENT? CITATION: CLIN RES CARDIOL (2014) 103:133¿140 AUTHORS: BART M. KOENE ¿ MOHAMED A. SOLIMAN HAMAD ¿ WOBBE BOUMA ¿ MASSIMO A. MARIANI ¿ KATHINKA C. PEELS ¿ JAN-MELLE VAN DANTZIG ¿ ALBERT H. VAN STRATEN DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING A RETROSPECTIVE STUDY WHICH EVALUATED THE EFFECT OF THE MEAN TRANSPROSTHETIC PRESSURE GRADIENT (TPG) ON LATE ALL-CAUSE MORTALITY FOLLOWING AORTIC VALVE REPLACEMENT (AVR) OR AVR WITH CORONARY ARTERY BYPASS GRAFTING (CABG). THE STUDY POPULATION INCLUDED 2,957 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 68 +/- 1 YEARS), 1,701 OF WHICH UNDERWENT AVR AND 1,256 OF WHICH UNDERWENT AVR WITH CABG WITH A MECHANICAL OR STENTED BIOLOGICAL AORTIC PROSTHETIC VALVE, ALL FROM A SINGLE (B)(6) INSTITUTION BETWEEN JANUARY 1998 AND MARCH 2012. AMONG ALL PATIENTS, 98 RECEIVED A MEDTRONIC MOSAIC BIOPROSTHETIC VALVE (SERIAL NUMBERS NOT PROVIDED). THERE WERE 57 DEATHS WITHIN SIX WEEKS OF IMPLANT. OVERALL SURVIVAL FOR THE ENTIRE GROUP AT 1, 3, 5, AND 10 YEARS WAS 97, 93, 87 AND 67 %, RESPECTIVELY. NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. BASED ON TPG RESULTS THE PATIENTS WERE PLACED INTO THREE GROUPS: 876 PATIENTS WERE LOW TPG (=10 MMHG), 1,148 PATIENTS WERE MEDIUM TPG (10 - 19 MMHG), AND 204 PATIENTS WERE HIGH TPG (=20 MMHG). OTHER CLINICAL OBSERVATIONS INCLUDED: 95 ENDOCARDITIS, 122 RENAL DYSFUNCTION, AND 112 CEREBRAL VASCULAR ACCIDENTS (CVA). OF NOTE, IT WAS NOT CLEAR WHETHER THESE OBSERVATIONS OCCURRED PRIOR TO OR FOLLOWING PROSTHETIC VALVE IMPLANT. ADDITIONALLY, THERE WAS NO INDICATION OF INTERVENTION OR REOPERATION TO ADDRESS ANY OF THE NOTED OBSERVATIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238647 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 30525

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Life Threatening