BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK

    MDR report key: 11115953 · Received January 5, 2021

    Report

    Report Number
    2025587-2021-00024
    Event Type
    Injury
    Date Received
    January 5, 2021
    Date of Event
    October 6, 2017
    Report Date
    January 5, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P790007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: HAAS N., ET AL. EARLY OUTCOMES OF PERCUTANEOUS PULMONARY VALVE IMPLANTATION USING THE EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE SYSTEM. INT J CARDIOL, 2018 JAN 1; 250:86-91. PMID: 29017776. DOI: 10.1016/J.IJCARD.2017.10.015. EPUB 2017 OCT 6. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. MEDTRONIC PRODUCTS REFERENCED: HANCOCK (PMA# P790007, PRODUCT CODE: LWR). EARLIEST APPROVED PRODUCT USED FOR D2 PRODUCT CODE AND G5 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 EARLY OUTCOMES AFTER NON-MEDTRONIC PERCUTANEOUS PULMONARY VALVE IMPLANTATION (PPVI) IN CONGENITAL HEART DEFECT PATIENTS WITH PRIOR SURGICAL CORRECTION OF THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A CLINICAL REGISTRY INVOLVING MULTIPLE CENTERS BETWEEN NOVEMBER 2014 AND MAY 2017. THE STUDY POPULATION INCLUDED 46 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 29 YEARS), WITH AN UNKNOWN NUMBER OF WHOM HAD UNDERGONE PRIMARY SURGICAL RVOT CORRECTION USING MEDTRONIC HANCOCK VALVED CONDUITS (NO SERIAL NUMBERS PROVIDED). AMONG ALL MEDTRONIC PATIENTS, ADVERSE EVENTS INCLUDED: VALVE DYSFUNCTION CAUSING MODERATE-SEVERE PULMONARY REGURGITATION, WHICH REQUIRED VALVE-IN-VALVE PPVI USING A NON-MEDTRONIC BIOPROSTHETIC VALVE. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY 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
    14576 HANCOCK HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION HC150-12

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Life Threatening| R