BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 16457665 · Received February 28, 2023

    Report

    Report Number
    2025587-2023-00735
    Event Type
    Injury
    Date Received
    February 28, 2023
    Date of Event
    October 26, 2022
    Report Date
    February 28, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: LAWLEY C.; ET AL. TEN YEARS OF PERCUTANEOUS PULMONARY VALVE IMPLANTATION IN AUSTRALIA AND NEW ZEALAND. HEART LUNG CIRC. 2022 DEC;31(12):1649-1657. DOI: 10.1016/J.HLC.2022.07.008. EPUB (B)(6) 2022 . PMID: 36038469 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: CONTEGRA (PMA# H020003, PRODUCT CODE: MWH); HANCOCK (PMA# P980043, PRODUCT CODE: DYE); MOSAIC (PMA# P990064, PRODUCT CODE: DYE); FREESTYLE (PMA# P970031, PRODUCT CODE: LWR); MELODY (PMA# P140017, PRODUCT CODE: NPV). 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. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING A MULTI-CENTER LONGITUDINAL STUDY ON PERCUTANEOUS PULMONARY VALVE IMPLANTATION (PPVI) IN AUSTRALIA AND NEW ZEALAND. THERE WERE PATIENTS WHO EXPERIENCED BIOPROSTHETIC VALVE STENOSIS/REGURGITATION, REQUIRING REPLACEMENT. THE STATUS OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148317 MEDTRONIC SURGICAL TISSUE VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male Life Threatening| H| R UNKNOWN IPG