BEUDAMED
    FDA Adverse Event Death Summary report: N

    HARMONY TRANSCATHETER PULMONARY VALVE

    MDR report key: 20097973 · Received August 29, 2024

    Report

    Report Number
    2025587-2024-04886
    Event Type
    Death
    Date Received
    August 29, 2024
    Date of Event
    August 9, 2024
    Report Date
    October 8, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    P200046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    UPDATED DATA: B5. B7. 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

    MEDTRONIC HAS REQUESTED ADDITIONAL INFORMATION PERTAINING TO THIS REPORTABLE EVENT. IF ADDITIONAL REPORTABLE INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 THE VALVE WAS NEVER STENTED. THE PATIENT WAS HOSPITALIZED DUE TO HIGH GRADIENTS AT APPROXIMATELY 70 MMHG, AS WELL AS LEAFLET THICKENING AND VEGETATION. THE PATIENT WAS POSITIVE FOR INFECTIVE ENDOCARDITIS (IE). THE SUSPECTED CAUSE OF IE WAS NASAL PACKING DUE TO INCREASED NOSE BLEEDS FROM THE ANTICOAGULANTS, AND OR SELF INFLICTED SCRATCHING SKIN WOUNDS. THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE PATIENT PASSED AWAY FROM ECMO COMPLICATIONS ONE MONTH AFTER VALVE IMPLANT.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT 24 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT WAS HOSPITALIZED DUE TO THROMBUS AND HIGH GRADIENTS. THE VALVE WAS SUBSEQUENTLY STENTED. IT WAS NOTED THAT THE VALVE GRADIENT AT DISCHARGE OF THE PATIENT WAS 10 MILLIMETERS OF MERCURY (MM HG) AND THE THROMBUS WAS LOCATED ON THE INFLOW OF THE VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS NEVER STENTED. THE PATIENT WAS HOSPITALIZED DUE TO HIGH GRADIENTS AT APPROXIMATELY 70 MMHG, AS WELL AS LEAFLET THICKENING AND VEGETATION. THE PATIENT WAS POSITIVE FOR INFECTIVE ENDOCARDITIS (IE). THE SUSPECTED CAUSE OF IE WAS NASAL PACKING DUE TO INCREASED NOSE BLEEDS FROM THE ANTICOAGULANTS, AND OR SELF INFLICTED SCRATCHING SKIN WOUNDS. THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE PATIENT PASSED AWAY FROM ECMO COMPLICATIONS ONE MONTH AFTER VALVE IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE MEAN GRADIENT BEFORE THE VALVE WAS IMPLANTED WAS 7 MMHG FROM THE RIGHT VENTRICLE-RIGHT PULMONARY ARTERY AND 6 MMHG FROM THE RIGHT VENTRICLE-LEFT PULMONARY ARTERY. THE ENDOCARDITIS WAS CONFIRMED 25 DAYS FOLLOWING VALVE IMPLANT, AND METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS WAS THE CULTURED ORGANISM. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS MULTIORGAN DYSFUNCTION SYNDROME FROM SEVERE SEPSIS, STAPH ENDOCARDITIS, VALVE DYSFUNCTION, AND RIGHT HEART FAILURE. THE PATIENT DID NOT HAVE ANY RECENT DENTAL WORK; HOWEVER, NOSE BLEEDS AND NASAL PACKING OCCURRED PRIOR TO THE ENDOCARDITIS.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT 24 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT WAS HOSPITALIZED DUE TO THROMBUS AND HIGH GRADIENTS. THE VALVE WAS SUBSEQUENTLY STENTED. IT WAS NOTED THAT THE VALVE GRADIENT AT DISCHARGE OF THE PATIENT WAS 10 MILLIMETERS OF MERCURY (MM HG) AND THE THROMBUS WAS LOCATED ON THE INFLOW OF THE VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355590 HARMONY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI NPV MEDTRONIC HEART VALVES DIVISION HARMONY-22

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female Required Intervention| D| H