BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 12292283 · Received August 9, 2021

    Report

    Report Number
    2025587-2021-02483
    Event Type
    Injury
    Date Received
    August 9, 2021
    Date of Event
    May 8, 2021
    Report Date
    August 8, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MAEDA K., ET AL. DURABILITY OF PULMONARY VALVE REPLACEMENT WITH LARGE DIAMETER STENTED PORCINE BIOPROSTHESES. SEMIN. THORAC. CARDIOVASC. SURG., 2021 MAY 8; PII: S1043-0679(21)00192-1. DOI: 10.1053/J.SEMTCVS.2021.03.044. PMID: 33971298 EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: MOSAIC (PMA# P990064, PRODUCT CODE: DYE); HANCOCK (PMA# P870078, PRODUCT CODE: DYE). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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 THE DURABILITY OF PORCINE BIOPROSTHESES FOR SURGICAL PULMONARY VALVE REPLACEMENT (PVR). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2002 AND 2019. THE STUDY POPULATION INCLUDED 203 PATIENTS (MEAN AGE 21 YEARS, MEAN WEIGHT 64 KG), 190 OF WHOM WERE IMPLANTED WITH MEDTRONIC MOSAIC SURGICAL BIOPROSTHETIC VALVES AND 12 OF WHOM WERE IMPLANTED WITH MEDTRONIC HANCOCK SURGICAL BIOPROSTHETIC VALVES (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, TWO DEATHS OCCURRED WITHIN ONE YEAR AND SEVEN YEARS POST-PVR. THE DEATHS WERE NOTED TO BE UNRELATED TO THE REPLACEMENT SURGERY OR THE BIOPROSTHETIC VALVES. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL MEDTRONIC PATIENTS, ADVERSE EVENTS INCLUDED: NEED FOR SURGICAL OR TRANSCATHETER PULMONARY VALVE REPLACEMENT DUE TO MODERATE-SEVERE PULMONARY REGURGITATION, MODERATE-SEVERE PULMONARY STENOSIS, OR MIXED DISEASE. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190064 MEDTRONIC SURGICAL TISSUE VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Life Threatening| R