BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 20689167 · Received November 14, 2024

    Report

    Report Number
    2025587-2024-06558
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    June 12, 2023
    Report Date
    November 14, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT EIGHT YEARS AND EIGHT MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, ROUTINE ECHOCARDIOGRAM REVEALED NORMAL VALVE FUNCTION WITH ABSENCE OF PULMONARY INSUFFICIENCY AND A MILD - MODERATE PULMONARY STENOSIS WITH VMAX OF 3.9 M/S AND A MAXIMUM PEAK GRADIENT OF 62MMHG. FOUR MONTHS AND TWO DAYS LATER, THE PATIENT WAS ADMITTED TO HOSPITAL. ECHOCARDIOGRAM FINDINGS AND SPIRO-ERGOMETRY REVEALED REDUCED MAXIMUM OXYGEN CONSUMPTION RATE OF 24ML/KG X MIN. MAGNETIC RESONANCE IMAGING (MRI) SIX DAYS AFTER HOSPITALIZATION SHOWED MODERATE PULMONARY STENOSIS AND MILD CENTRAL INSUFFICIENCY. OUTGROWTH WAS TAKEN INTO ACCOUNT FOR RE-INTERVENTION AS THE IMPLANT WAS AT AGE 12 AND THE PATIENT NOW WAS 20 AND HAD INCREASED BODY WEIGHT BY FACTOR 3-4. FOUR MONTHS AND 13 DAYS FOLLOWING INITIAL DIAGNOSTIC HOSPITALIZATION, THE PATIENT WAS TREATED WITH A VALVE-IN-VALVE PROCEDURE. THE PATIENT¿S RIGHT VENTRICLE (RV) PRESSURE WAS 86MMHG, FEMORAL ARTERY 99MMHG, RV-PULMONARY ARTERY (PA) GRADIENT 50MMHG. THE TEAM PERFORMED SERIAL DILATION OF THE VALVE AND PRE-STENT WITH ATLAS GOLD ULTRA-HIGH PRESSURE BALLOONS SIZE 22MM AND 24MM. THIS WAS FOLLOWED BY THE IMPLANT OF A NEW VALVE (F593618) INSIDE THE ORIGINAL VALVE (B247416) USING A 22MM ENSEMBLE; REVEALING RV PRESSURE OF 54MMHG, FEMORAL ARTERY 115MMHG, RV-PA GRADIENT 22MMHG, AND NO INSUFFICIENCY. STENOSIS REMAINED WITHIN THE STENTS AND NEW VALVE, MOST LIKELY CAUSED BY A PROXIMAL SUBSTERNAL NON-COMPRESSIBLE BLOCK OF PANNUS TISSUE. FURTHER DILATION WITH ATLAS GOLD 22MM BALLOON DID NOT IMPROVE HEMODYNAMICS OR SIGNIFICANTLY REDUCE THE PANNUS AREA. PER THE PHYSICIAN, IMAGING SHOWED NON-RADIOPAQUE AREA WITHIN THE STENTS, THEREFORE WITH THE ABSENCE OF VISIBLE CALCIFICATION AND NO ENDOCARDITIS IN PATIENT HISTORY AS WELL AS ABSENCE OF ANY STENT FRACTURES, PANNUS IS THE ONLY EXPLANATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2285421 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI NPV MEDTRONIC HEART VALVES DIVISION PB1018

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male