BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 15468538 · Received September 22, 2022

    Report

    Report Number
    2025587-2022-02613
    Event Type
    Death
    Date Received
    September 22, 2022
    Date of Event
    May 4, 2019
    Report Date
    September 22, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: CHOI P.; ET AL. REVISITING PROSTHESIS CHOICE IN MITRAL VALVE REPLACEMENT IN CHILDREN: DURABLE ALTERNATIVES TO TRADITIONAL BIOPROSTHESES. J THORAC CARDIOVASC SURG 2021 JAN 01; 161(1):P213-225.E3. DOI: 10.1016/J.JTCVS.2020.04.173. AVAILABLE AHEAD OF PRINT MAY 31, 2020. READ AT THE 99TH ANNUAL MEETING OF THE AMERICAN ASSOCIATION FOR THORACIC SURGERY, TORONTO, ONTARIO, CANADA, MAY 4-7, 2019. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: HANCOCK VALVED CONDUIT (PMA# P790007, PRODUCT CODE: LWR); MOSAIC (PMA# P990064, PRODUCT CODE: DYE); 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. 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

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE COMPARING DURABILITY OF MECHANICAL, PORCINE, PERICARDIAL, AND STENTED JUGULAR VEIN VALVES USED FOR SURGICAL MITRAL VALVE REPLACEMENT (MVR) IN PEDIATRIC CONGENITAL HEART DISEASE PATIENTS. ALL DATA WERE COLLECTED FROM A SINGLE MEDICAL CENTER BETWEEN JANUARY 1992 AND JULY 2018. THE STUDY POPULATION INCLUDED 190 PATIENTS AND MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. FOUR PATIENTS WERE IMPLANTED WITH A MEDTRONIC HANCOCK VALVED CONDUIT; FOUR WERE IMPLANTED WITH A MEDTRONIC MOSAIC BIOPROSTHETIC VALVE AND 34 WERE IMPLANTED WITH A MEDTRONIC MELODY BIOPROSTHETIC VALVE (MEDTRONIC VALVE COHORT WAS PREDOMINANTLY FEMALE, MEDIAN AGE 3.2 YEARS). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 44 PEDIATRIC DEATHS OCCURRED, WITH 15 OF THE DEATHS NOTED TO BE INTRA-OPERATIVE. CAUSES OF DEATHS INCLUDED MULTIORGAN FAILURE, SEPSIS, CARDIAC ARREST, CONGESTIVE HEART FAILURE (CHF), RIGHT/LEFT VENTRICULAR FAILURE, INTRACRANIAL HEMORRHAGE, PULMONARY HEMORRHAGE, GASTROINTESTINAL HEMORRHAGE, PULMONARY HYPERTENSION, ENDOCARDITIS AND OTHER UNKNOWN CAUSES. THERE WAS NO DIRECT STATEMENT OF CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS, HOWEVER, THE STUDY DID NOTE VARIED RISKS OF DEATH BASED UPON VALVE TYPE IMPLANTED. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEED FOR MULTIPLE BALLOON DILATATIONS TO RESOLVE HIGH TRANSVALVULAR GRADIENTS; NEED FOR RE-DO SURGICAL MVR DUE TO MITRAL STENOSIS/REGURGITATION, VALVE THROMBOSES, LEAFLET ENTRAPMENT AND PARAVALVULAR LEAKS (PVL). UPON RE-OPERATION, ALL EXPLANTED PORCINE VALVES HAD SIGNIFICANT PANNUS AND CALCIFICATION AND MOST EXPLANTED MELODY VALVES HAD PERFORATED LEAFLETS. 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
    553298 MEDTRONIC SURGICAL TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Female Life Threatening| D| R