BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 11937430 · Received June 4, 2021

    Report

    Report Number
    2025587-2021-01776
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    December 16, 2019
    Report Date
    June 4, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: COCOMELLO L, MELONI M, RAPETTO F, BAQUEDANO M, ORDOÑEZ MV, BIGLINO G, BUCCIARELLI-DUCCI C, PARRY A, STOICA S, CAPUTO M. LONG-TERM COMPARISON BETWEEN PULMONARY HOMOGRAFT VERSUS BIOPROSTHESIS FOR PULMONARY VALVE REPLACEMENT IN TETRALOGY OF FALLOT. J AM HEART ASSOC. 2019 DEC 17;8(24):E013654. DOI: 10.1161/JAHA.119.013654. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A LONG-TERM COMPARISON BETWEEN PULMONARY HOMOGRAFT AND PULMONARY BIOPROSTHESIS IMPLANTATION IN PATIENTS WITH TETRALOGY OF FALLOT (TOF). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 1995 AND 2018. THE STUDY POPULATION INCLUDED 209 PATIENTS, 62 OF WHOM WERE IMPLANTED WITH MEDTRONIC HANCOCK BIOPROSTHETIC SURGICAL VALVE INTO THE PULMONARY POSITION. THE PATIENTS IMPLANTED WITH A BIOPROSTHETIC VALVE WERE PREDOMINANTLY MALE WITH A MEAN AGE 24 YEARS. THE REMAINING PATIENTS WERE IMPLANTED WITH A NON-MEDTRONIC BIOPROSTHESIS (73) OR A NON-MEDTRONIC HOMOGRAFT (75). NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, NO DEATHS WERE ASSOCIATED WITH A MEDTRONIC DEVICE. AMONG ALL PATIENTS IMPLANTED WITH A BIOPROSTHETIC SURGICAL VALVE, ADVERSE EVENTS INCLUDED: UNSPECIFIED STRUCTURAL VALVE DYSFUNCTION (SVD), ENDOCARDITIS AND MILD PULMONARY REGURGITATION. BASED ON THE AVAILABLE INFORMATION A MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836494 HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T505

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention