BEUDAMED
    FDA Adverse Event Death Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 19157522 · Received April 22, 2024

    Report

    Report Number
    2025587-2024-02425
    Event Type
    Death
    Date Received
    April 22, 2024
    Date of Event
    January 4, 2022
    Report Date
    April 22, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MCELHINNEY DB, ZHANG Y, LEVI DS, ET AL. REINTERVENTION AND SURVIVAL AFTER TRANSCATHETER PULMONARY VALVE REPLACEMENT. J AM COLL CARDIOL. 2022;79(1):18-32. DOI:10.1016/J.JACC.2021.10.031 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED IN THE ARTICLE: CONTEGRA CONDUIT AND MELODY VALVE. THIS REPORT PERTAINS TO THE CARDIAC DEATHS THAT MAY BEEN ASSOCIATED WITH THE MELODY VALVE. 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 SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE MID- AND LONG-TERM OUTCOMES AFTER TRANSCATHETER PULMONARY VALVE REPLACEMENT (TPVR). A TOTAL OF 2,476 PATIENTS WHO UNDERWENT TPVR WERE INCLUDED IN THE STUDY POPULATION. OF THESE PATIENTS, 215 HAD A PREVIOUSLY IMPLANTED MEDTRONIC CONTEGRA CONDUIT. REASONS FOR TPVR CONSISTED OF OBSTRUCTION, PULMONARY REGURGITATION, AND MIXED OBSTRUCTION AND REGURGITATION. MEDTRONIC MELODY (N = 2,038) AND NON-MEDTRONIC SAPIEN (N = 438) VALVE TYPES WERE USED FOR TPVR. THE AUTHORS STATED THAT 95 PATIENTS WERE KNOWN TO HAVE DIED AFTER TPVR. CAUSES OF DEATH WERE DIVIDED INTO THREE CATEGORIES: CARDIAC, NON-CARDIAC, AND UNKNOWN. THE CARDIAC DEATHS WERE DUE TO HEART FAILURE, ENDOCARDITIS, ARRHYTHMIA/MYOCARDIAL INFARCTION, POST-REOPERATION/REINTERVENTION COMPLICATIONS, AND TPVR PROCEDURE-RELATED (CORONARY ARTERY COMPRESSION, CONDUIT RUPTURE, HEMORRHAGIC STROKE, AND COMPLICATIONS FOLLOWING SURGERY PERFORMED BECAUSE BRANCH PULMONARY ARTERY WAS JAILED DURING TPVR). OTHER ADVERSE EVENTS THAT OCCURRED AFTER TPVR: HEART TRANSPLANT FOR PROGRESSIVE HEART FAILURE, HIGH PEAK GRADIENT (15 MM HG), AND NEED FOR REINTERVENTION (SURGICAL EXPLANT AND REPLACEMENT, VALVE-IN-VALVE TPVR, OR BALLOON DILATION). REASONS FOR INITIAL REINTERVENTION AFTER TVPR: RIGHT VENTRICULAR OUTFLOW TRACT OBSTRUCTION, PULMONARY REGURGITATION, ENDOCARDITIS, AORTA-TO-PULMONARY ARTERY FISTULA, EMBOLIZATION OF FRACTURED VALVE, HEMOPERICARDIUM FROM STABLE CONDUIT RUPTURE, AND TPVR PROCEDURAL COMPLICATION (EMBOLIZED OR UNSTABLE VALVE, CORONARY COMPRESSION, AORTIC DISTORTION, CONDUIT RUPTURE, AND AORTA-TO-PULMONARY ARTERY FISTULA). NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111141 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI NPV MEDTRONIC HEART VALVES DIVISION PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Unknown Death