BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 11106301 · Received January 4, 2021

    Report

    Report Number
    2025587-2021-00003
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    July 1, 2020
    Report Date
    February 11, 2021
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED IS SUMMARIZED IN THE ATTACHED SPREADSHEET ENTITLED ¿PE 704115531 SPREADSHEET¿. 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

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR PROVIDED DETAILS ON EIGHT PATIENTS IMPLANTED WITH HANCOCK CONDUIT. A REVIEW OF THE MEDTRONIC GLOBAL COMPLAINT HANDLING DATABASE WITH THE PROVIDED UNIQUE DEVICE IDENTIFIER NUMBERS FOUND EIGHT CORRESPONDING PRODUCT EVENTS (PES). FOUR OF THE EIGHT PES HAVE CORRESPONDING MEDICAL DEVICE REPORTS (MDRS). THE PE AND MDR INFORMATION IS SUMMARIZED IN THE ATTACHED SPREADSHEET ENTITLED ¿PE 704115531 SPREADSHEET¿. NO FURTHER DETAILS WERE PROVIDED REGARDING ANY OF THE OTHER PATIENTS OR DEVICES FROM THE LITERATURE.

    Additional Manufacturer Narrative · 1

    CITATION: GEORGIEV S., ET AL. MUNICH COMPARATIVE STUDY: PROSPECTIVE LONG-TERM OUTCOME OF THE TRANSCATHETER MELODY VALVE VERSUS SURGICAL PULMONARY BIOPROSTHESIS WITH UP TO 12 YEARS OF FOLLOW-UP. CIRC CARDIOVASC INTERV., 2020 JUL; 13(7):E008963. PMID: (B)(4). DOI: 10.1161/CIRCINTERVENTIONS.119.008963. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE AND DEATH DATE. MEDTRONIC PRODUCTS REFERENCED: MELODY (PMA# P140017, PRODUCT CODE: NPV); HANCOCK (PMA# P790007, PRODUCT CODE: LWR); CONTEGRA (PMA# H020003, PRODUCT CODE: MWH). 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 VIA LITERATURE COMPARING DECADE-PLUS LONG-TERM OUTCOMES BETWEEN TRANSCATHETER AND SURGICAL PULMONARY BIOPROSTHESES IMPLANTED FOR RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) OBSTRUCTION. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2006 AND DECEMBER 2018. THE STUDY POPULATION INCLUDED 451 PATIENTS (MEAN AGE 19 YEARS, MEAN WEIGHT 58 KG), 241 OF WHOM WERE IMPLANTED WITH MEDTRONIC MELODY BIOPROSTHETIC VALVES, 57 WITH MEDTRONIC HANCOCK VALVED CONDUITS AND 11 WITH MEDTRONIC CONTEGRA VALVED CONDUITS (NO SERIAL NUMBERS PROVIDED). AMONG ALL MEDTRONIC MELODY PATIENTS, 7 DEATHS OCCURRED, WITH TWO DEATHS NOTED TO HAVE BEEN PROCEDURE-RELATED, FROM MYOCARDIAL INFARCTION SECONDARY TO CORONARY COMPRESSION AND CONDUIT RUPTURE DURING VALVE IMPLANTATION. THE REMAINING FIVE PATIENTS DIED IN A SPAN OF 8 MONTHS TO 7 YEARS POST-IMPLANTATION, WITH NO FURTHER INFORMATION PROVIDED. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE TWO DEATHS DURING VALVE IMPLANTATION. AMONG ALL SURGICAL VALVE/CONDUIT PATIENTS, OVERALL MORTALITY WAS 5.2%, WITH SOME EARLY POST-OPERATIVE DEATHS DUE TO LEFT VENTRICULAR FAILURE, SEPSIS AND NEUROLOGICAL COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL MEDTRONIC MELODY AND ALL SURGICAL VALVE PATIENTS, ADVERSE EVENTS INCLUDED: VALVE FAILURE, ENDOCARDITIS, RECURRENT PULMONARY STENOSIS AND PULMONARY REGURGITATION WITH MEAN TRANSVALVULAR GRADIENT INCREASES REQUIRING VALVE REPLACEMENT, EITHER BY TRANSCATHETER VALVE-IN-VALVE IMPLANTATION OR SURGICAL REPLACEMENT AND ANTIBIOTIC TREATMENT. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN 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
    6396 MEDTRONIC SURGICAL TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Life Threatening| R