BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 10936869 · Received December 2, 2020

    Report

    Report Number
    2025587-2020-03665
    Event Type
    Injury
    Date Received
    December 2, 2020
    Date of Event
    October 30, 2020
    Report Date
    February 9, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    UDI-DI
    00643169588196
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT PER THE PHYSICIAN, THE HIGH GRADIENT WAS DUE TO THE TUMOR MASS. THE SEVERE PULMONARY INSUFFICIENCY (PI) REPORTED OCCURRED AS A RESULT OF THE PRE-STENTS THAT WERE PLACED PRIOR TO THE IMPLANT OF THE SECOND TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE. PRIOR TO THE PLACEMENT OF THE STENTS, THERE WAS NO SIGNIFICANT PI. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. H6 - PATIENT CODE E062103 WAS SUBSEQUENTLY REMOVED AS THE VALVE WAS NOT THE CAUSE OF THE EVENT. 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

    PRODUCT ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE 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 FROM THE PHYSICIAN THAT TWO YEARS, ONE MONTH AND ELEVEN DAYS AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE, THE PATIENT PRESENTED WITH SEVERE, UNREMITTING RIGHT HEART FAILURE AND SEVERE RIGHT VENTRICULAR OUTFLOW TRACT OBSTRUCTION CAUSED BY RECURRENCE OF HER ANGIOSARCOMA TUMOR. A RIGHT VENTRICULAR PRESSURE OF 75/27 AND A PULMONARY ARTERY PRESSURE OF 29/13 WERE REPORTED. MULTI PLANAR IMAGING AND 3D MODELING REVEALED THAT THE TUMOR HAD EXTENDED FAR DOWN INTO THE VENTRICLE, AND BACK TO THE SEPTAL LEAFLET OF THE TRICUSPID VALVE. IMAGING SHOWED A LARGE MASS CAUSING SEVERE RIGHT VENTRICULAR OUTFLOW TRACT OBSTRUCTION. ANGIOGRAPHY IMAGING ALSO SHOWED SIGNIFICANT PULMONARY INSUFFICIENCY. A NON-MEDTRONIC EXTRA-LARGE STENT WAS PLACED WITH THE DISTAL MARGIN DIRECTLY ACROSS THE DISTAL MARGIN OF THE PREVIOUSLY IMPLANTED TRANSCATHETER BIOPROSTHETIC PULMONARY MELODY VALVE AND STENTS AS TO COVER ALL OF THE DISTAL TUMOR. A SECOND NON-MEDTRONIC WAS IMPLANTED, WITH SPECIAL ATTENTION TO ENSURE THE STENT EXTENDED AS FAR DOWN INTO THE RIGHT VENTRICLE, TO COVER AS MUCH TUMOR AS POSSIBLE WITHOUT INTERFERING WITH THE TRICUSPID VALVE. A SECOND TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE WAS IMPLANTED INTO AN IDENTICAL LOCATION AS THE PREVIOUS VALVE. FOLLOWING THE PROCEDURE, THE RIGHT VENTRICULAR PRESSURE MEASURED 56/18 AND THE PULMONARY ARTERY PRESSURE 53/19, INDICATING ESSENTIALLY NO GRADIENT ACROSS THE RIGHT VENTRICULAR OUTFLOW TRACT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398547 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB1018 00643169588196

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention