BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY TRANSCATHETER PULMONIC VALVE

    MDR report key: 8240024 · Received January 11, 2019

    Report

    Report Number
    2025587-2019-00156
    Event Type
    Injury
    Date Received
    January 11, 2019
    Date of Event
    June 2, 2017
    Report Date
    April 9, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PREVIOUS REPORTS WERE SUBMITTED ON A PRODUCT THAT WAS NOT MARKETED/COMMERCIALLY DISTRIBUTED AND NOT SIMILAR TO A DEVICE MARKETED/COMMERCIALLY DISTRIBUTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    REPORT SOURCE PMA / 510(K) #: CORRECTION TO P140017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE RIGHT VENTRICULAR OUTFLOW TRACT OBSTRUCTION AND INCREASED RIGHT VENTRICLE PRESSURES WAS A STENT FRACTURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT REMAINS IMPLANTED; THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED.   CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT TWO YEARS AND SIX MONTHS AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, TWO BALLOON DILATIONS OF THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) WERE PERFORMED DUE TO RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) OBSTRUCTION AND INCREASED RIGHT VENTRICLE PRESSURE. A SECOND TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE WAS THEN IMPLANTED, VALVE-IN-VALVE. ONE DAY POST VALVE-IN-VALVE, NO SIGNIFICANT STENOSIS OR REGURGITATION WERE NOTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31536 HARMONY TRANSCATHETER PULMONIC VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION HTPV254952

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention