BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 24286054 · Received February 7, 2026

    Report

    Report Number
    9617601-2026-01030
    Event Type
    Injury
    Date Received
    February 7, 2026
    Date of Event
    December 29, 2025
    Report Date
    February 7, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: BIANCO ET AL. TRANSAPICAL MITRAL VALVE-IN-VALVE IMPLANTATION IN LESS THAN 10 KG CHILDREN. PEDIATR CARDIOL. 2025 DEC 29. DOI: 10.1007/S00246-025-04142-7. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. 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 TWO PEDIATRIC CASES OF TRANSAPICAL MITRAL VALVE-IN-VALVE IMPLANTATION. CASE 1: AN 8-MONTH-OLD 6.4-KG MALE PATIENT WITH SEVERE MIXED MITRAL VALVE (MV) DISEASE UNDERWENT SURGICAL REPLACEMENT WITH IMPLANT OF A MEDTRONIC 20-MM MELODY BIOPROSTHETIC VALVE REINFORCED WITH A PERICARDIAL SKIRT. POSTOPERATIVE DOPPLER EVALUATION REVEALED SEVERE MITRAL STENOSIS WITH AN 18 MMHG MEAN GRADIENT. AT 12 MONTHS POST-IMPLANT, THE PATIENT UNDERWENT MV BALLOON DILATION WITH ¿GOOD RESULTS¿. AT 21 MONTHS POST-IMPLANT, DUE TO RECURRENT MV STENOSIS, THE PATIENT UNDERWENT A REDO MV BALLOON DILATION. FOLLOWING BALLOON DEFLATION AN ACUTE MITRAL OBSTRUCTION OCCURRED AT THE DISTAL END OF THE MELODY VALVE RESULTING IN LOW CARDIAC OUTPUT AND CARDIOCIRCULATORY ARREST. FLUOROSCOPY SHOWED NO EVIDENCE OF VALVE STENT FRACTURE. A SECOND 20-MM MELODY VALVE WAS THEN IMPLANTED WITH IMMEDIATE IMPROVEMENT AND NORMAL VALVE FUNCTION. DURING POST-OPERATIVE RECOVERY A HYPOXIC-ISCHEMIC BRAIN INJURY WAS IDENTIFIED WHICH WAS MANAGED CONSERVATIVELY. THE PATIENT SHOWED PROGRESSIVE IMPROVEMENT AND WAS DISCHARGED HOME ON ASPIRIN. AT A FOLLOW-UP 18 MONTHS LATER, THE PATIENT EXHIBITED A FAVORABLE NEUROLOGICAL OUTCOME ALONG WITH EXCELLENT MV FUNCTION WITH NO REGURGITATION OR STENOSIS. CASE 2: A 2-MONTH-OLD 4.7-KG MALE PATIENT WITH A SEVERELY DYSPLASTIC MITRAL VALVE (MV) UNDERWENT SURGICAL REPLACEMENT WITH IMPLANT OF A MEDTRONIC 20-MM MELODY BIOPROSTHETIC VALVE. POSTOPERATIVE ECHOCARDIOGRAPHY SHOWED ONLY MILD MITRAL REGURGITATION WITH NO STENOSIS. AT ONE MONTH POST-IMPLANT, A HYPERECHOGENIC STRUCTURE WAS FOUND THAT WAS A POTENTIAL SIGN OF EARLY LEAFLET DEGENERATION. AT THREE MONTHS POST-IMPLANT, THE MITRAL REGURGITATION WORSENED TO MODERATE SEVERITY. NO VALVE STENT FRACTURE, THROMBUS, OR VEGETATION WAS IDENTIFIED. AT 11 MONTHS POST-IMPLANT THE PATIENT EXPERIENCED SYMPTOMATIC SEVERE MV REGURGITATION WHICH REQUIRED INTERVENTION. IN THE SUBSEQUENT PROCEDURE, A SECOND 22-MM MELODY VALVE WAS IMPLANTED WITH EXCELLENT HEMODYNAMIC RESULTS. TWO DAYS LATER, THE PATIENT EXPERIENCED A CARDIOEMBOLIC ISCHEMIC STROKE, AND IMMEDIATELY UNDERWENT SURGICAL INTERVENTION WITH A DECOMPRESSIVE CRANIECTOMY AND EXPANSION DURAPLASTY. THE POST-OPERATIVE COURSE WAS FAVORABLE, AND THE PATIENT WAS DISCHARGED HOME ON ASPIRIN AND CLOPIDOGREL. AT A ONE-YEAR FOLLOW-UP, THE MELODY VALVE FUNCTION WAS NOTED AS ¿EXCELLENT¿. AT A THREE-YEAR FOLLOW-UP, THE PATIENT REMAINED CLINICALLY STABLE WITH EXCELLENT FUNCTION OF THE MELODY VALVE DESPITE THIS MODERATE AND STABLE LEFT VENTRICLE OUTFLOW OBSTRUCTION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346657 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI NPV MEDTRONIC MEXICO S. DE R.L. DE CV PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 29 MO Male Life Threatening| H| R| C