BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 11081507 · Received December 28, 2020

    Report

    Report Number
    2025587-2020-03914
    Event Type
    Injury
    Date Received
    December 28, 2020
    Date of Event
    November 1, 2018
    Report Date
    December 22, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P870078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: HASCOET S ET AL. EARLY OUTCOMES OF PERCUTANEOUS PULMONARY VALVE IMPLANTATION USING THE EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE SYSTEM. EUROINTERVENTION. 2019 JAN 20;14(13):1378-1385. DOI: 10.4244/EIJ-D-18-01035. PUBLISHED ONLINE NOVEMBER 2018. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT (MONTH AND YEAR VALID). MEDTRONIC PRODUCT REFERENCED: HANCOCK STENTED BIOPROSTHESIS. NO FURTHER INFORMATION WAS PROVIDED. POTENTIAL PRODUCTS: HANCOCK STANDARD (PMA# P870078, PRO CODE DYE) OR HANCOCK II (PMA# P980043, PRO 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 FROM A LITERATURE ARTICLE REGARDING THE SAFETY, FEASIBILITY, AND HEMODYNAMIC OUTCOMES OF PERCUTANEOUS PULMONARY VALVE IMPLANTATION (PPVI) USING A SPECIFIC TYPE OF NON-MEDTRONIC TRANSCATHETER HEART VALVE. ALL DATA WERE COLLECTED FROM EIGHT CENTERS. THE STUDY POPULATION INCLUDED 82 PATIENTS AND WAS PREDOMINANTLY MALE WITH A MEAN AGE OF 27 YEARS AND A MEAN WEIGHT OF 61 KG. AN UNDISCLOSED NUMBER OF PATIENTS WERE PREVIOUSLY IMPLANTED WITH A MEDTRONIC HANCOCK STENTED BIOPROSTHESIS IN THE PULMONARY POSITION. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS WITH A PREVIOUSLY IMPLANTED STENTED BIOPROSTHESIS, ADVERSE EVENTS INCLUDED: PPVI (VALVE-IN-VALVE REPLACEMENT). PRIOR TO PPVI, THE FOLLOWING ADVERSE PATIENT EFFECTS WERE NOTED: HIGH GRADIENTS OVER THE RIGHT VENTRICULAR OUTFLOW TRACT, HEART FAILURE, MILD TO SEVERE PULMONARY REGURGITATION, AND MILD TO SEVERE TRICUSPID REGURGITATION. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS 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
    1549269 MEDTRONIC SURGICAL TISSUE VALVE HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention