BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY TRANSCATHETER PULMONARY VALVE

    MDR report key: 24737738 · Received March 30, 2026

    Report

    Report Number
    9617601-2026-02142
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    February 7, 2026
    Report Date
    March 30, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPV
    PMA / PMN Number
    P200046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: KOGURE ET AL. SAFETY AND EFFICACY OF HARMONY TRANSCATHETER PULMONARY VALVE IMPLANTATION - CLINICAL AND HEMODYNAMIC ASSESSMENT IN A SINGLE-CENTER JAPANESE COHORT. CIRC J. 2026 FEB 7. DOI: 10.1253/CIRCJ.CJ-25-0935. 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 THE SAFETY AND EFFICACY OF THE MEDTRONIC HARMONY BIOPROSTHETIC TRANSCATHETER PULMONARY VALVE. THE STUDY POPULATION INCLUDED 55 PATIENTS; ALL OF WHOM WERE IMPLANTED WITH A MEDTRONIC HARMONY TRANSCATHETER PULMONARY VALVE. ONE DEATH OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATH. AMONG ALL PATIENTS, CLINICAL OBSERVATIONS INCLUDED: PULMONARY ARTERY PERFORATION BY GUIDEWIRE, NEW ONSET NON-SUSTAINED VENTRICULAR TACHYCARDIA, MILD PULMONARY REGURGITATION, AND CONGESTIVE HEART FAILURE (CHF) REQUIRING HOSPITALIZATION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792065 HARMONY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI NPV MEDTRONIC MEXICO S. DE R.L. DE CV HARMONY-22

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| L| R