BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 6393594 · Received March 9, 2017

    Report

    Report Number
    2025587-2017-00382
    Event Type
    Injury
    Date Received
    March 9, 2017
    Date of Event
    May 24, 2016
    Report Date
    February 15, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: HISTOLOGY OF DEBRIS CAPTURED BY A CEREBRAL PROTECTION SYSTEM DURING TRANSCATHETER VALVE-IN-VALVE IMPLANTATION CITATION: HEART (2016) 102:1573¿1580 (DOI 10.1136/HEARTJNL-2016-309597) AUTHORS: TOBIAS SCHMIDT ET AL. EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT CANNOT 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 DEBRIS CAPTURED BY A CEREBRAL PROTECTION SYSTEM DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN APRIL 2013 AND NOVEMBER 2015. THE STUDY POPULATION INCLUDED 15 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 75 YEARS), 7 OF WHICH HAD BEEN IMPLANTED WITH A MEDTRONIC MOSAIC (2), HANCOCK (4) OR A COREVALVE (1) DEVICE. DURATION OF IMPLANT RANGED FROM 2-20 YEARS. ELEVEN MEDTRONIC TRANSCATHETER BIOPROSTHETIC VALVES WERE IMPLANTED VALVE-IN-VALVE (3 COREVALVE AND 8 EVOLUT R). MEDTRONIC RECEIVED INFORMATION THAT TWENTY YEARS AFTER THE IMPLANT OF THIS 21MM HANCOCK BIOPROSTHETIC AORTIC VALVE, AORTIC STENOSIS AND MODERATE AORTIC REGURGITATION WERE NOTED. SUBSEQUENTLY, A TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED, VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175375 HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T505

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention