BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONY DELIVERY CATHETER SYSTEM

    MDR report key: 23209613 · Received October 3, 2025

    Report

    Report Number
    9612164-2025-04895
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 5, 2025
    Report Date
    November 3, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NPV
    PMA / PMN Number
    P200046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B5. CORRECTED DATA: H8 - CORRECTED FROM BLANK TO INITIAL 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID HARMONY-25 (K069478); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2025; SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN THE REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS.  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

    ADDITIONAL INFORMATION WAS RECEIVED THAT CLARIFIED THE "POP-UP" REFERRING TO THE BEHAVIOR OF THE DELIVERY CATHETER SYSTEM (DCS) CAPSULE WHEN POSITIONING ITSELF IN THE BIFURCATION OF THE PULMONARY ARTERY(PA). PER THE PHYSICIAN, THE CURVATURE OF THE PA CONTRIBUTED TO THE DEPLOYMENT ISSUE. NO DIFFICULTY WAS NOTED DURING DEPLOYMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE GUIDEWIRE WAS INSERTED INTO THE RIGHT PULMONARY ARTERY (RPA) AND PULLED INTO THE MIDDLE PULMONARY ARTERY. SUBSEQUENTLY, ROWS 1-2 WERE DEPLOYED VIA "POP-UP". AFTER THESE ROWS WERE DEPLOYED, THE ENTIRE DELIVERY CATHETER SYSTEM (DCS) SHIFTED CAUSING THE OUTFLOW TO BE POSITIONED LOWER THAN THE EXPECTED DEPLOYMENT LOCATION. THE TIP OF THE INTRODUCER SHEATH WAS ADVANCED FROM THE CAPSULE OF THE DCS TO THE DISTAL, AND THE VALVE WAS RETRACTED INTO THE INTRODUCER SHEATH. AFTER THE VALVE WAS RECAPTURED, THE DCS WAS ADVANCED AGAIN TO THE RPA. ROW 1 WAS DEPLOYED VIA POP-UP. IMAGING WAS PERFORMED, AND IT WAS CONFIRMED THAT THERE WAS NO PROBLEM WITH THE POSITION. THE CONTRAST CATHETER WAS PULLED TO DEPLOY ROW 2. A SECOND CONTRAST IMAGING STUDY WAS PERFORMED, CONFIRMING NO PROBLEMS WITH THE VALVE POSITION. ROWS 3-6 WERE DEPLOYED AND THE VALVE WAS FULLY RELEASED. THE PROCEDURE WAS COMPLETED. NO PARAVALVULAR LEAK OR PRESSURE DIFFERENCE WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2426430 HARMONY DELIVERY CATHETER SYSTEM PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI NPV MEDTRONIC IRELAND HARMONY-DCS 0012623740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11...