BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 17378943 · Received July 24, 2023

    Report

    Report Number
    2025587-2023-02939
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    October 29, 2022
    Report Date
    July 24, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: FERNANDEZ A, LOZA G, PARMA G, ET AL. EARLY ANTICOAGULATION AFTER AORTIC VALVE REPLACEMENT WITH PORCINE BIOPROSTHESIS RANDOMIZED CONTROL TRIAL (ANTIPRO). EUR J CARDIOTHORAC SURG. 2022;63(1):EZAC507. DOI:10.1093/EJCTS/EZAC507. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: HANCOCK II (PRODUCT CODE DYE, PMA# P980043), MOSAIC (PRODUCT CODE DYE, PMA# P990064). 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. 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 EARLY ANTICOAGULATION AFTER AORTIC VALVE REPLACEMENT WITH PORCINE BIOPROSTHETIC VALVES. MEDTRONIC (HANCOCK II = 67, MOSAIC = 11) AND NON-MEDTRONIC (ST. JUDE EPIC = 62) VALVE TYPES WERE USED IN THE STUDY. THE AUTHORS OBSERVED 12 DEATHS WITHIN THIRTY DAYS OF VALVE IMPLANT. NO EVIDENCE WAS PRESENTED TO SUGGEST THAT A MEDTRONIC VALVE OR ITS FUNCTION CONTRIBUTED TO ANY OF THE DEATHS. OTHER ADVERSE EVENTS THAT OCCURRED WERE DESCRIBED AS FOLLOWS: ANEMIA, IMMEDIATE POST-OPERATIVE BLEEDING, SEVERE PERICARDIAL EFFUSION, POST-OPERATIVE ATRIAL FIBRILLATION, MAJOR BLEEDING (DEFINED AS AN OVERT BLEEDING EITHER ASSOCIATED WITH A DROP IN THE HEMOGLOBIN LEVEL OR REQUIRING TRANSFUSION OF 2 OR 3 UNITS, OR CAUSING HOSPITALIZATION OR PERMANENT INJURY, OR REQUIRINGSURGERY), MINOR BLEEDING, WORSENED NEW YORK HEART ASSOCIATION FUNCTIONAL CLASS (HEART FAILURE) AT ONE-YEAR POST-IMPLANT, INCREASED MEAN TRANSVALVULAR GRADIENT AT ONE-YEAR POST-IMPLANT, AND BIOPROSTHETIC VALVE DETERIORATION AT ONE-YEAR POST-IMPLANT. NO ADDITIONAL ADVERSE EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470853 MEDTRONIC SURGICAL TISSUE VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention