BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT FX DCS

    MDR report key: 20955658 · Received December 17, 2024

    Report

    Report Number
    2025587-2024-07383
    Event Type
    Death
    Date Received
    December 17, 2024
    Date of Event
    December 5, 2024
    Report Date
    January 9, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000365677
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B5. D4. H4. H6. 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 EVFXPLUS-26 (SERIAL: (B)(6)); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2024; EXPLANT DATE N/A PRODUCT ID L-EVOLUTFX-2329 (LOT NUMBER: UNKNOWN); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE N/A; EXPLANT DATE N/A. 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 PER THE PHYSICIAN, THE VALVE NOR THE DELIVERY CATHETER SYSTEM CAUSED OR CONTRIBUTED TO THE PERICARDIAL EFFUSION, RATHER THE NON-MEDTRONIC PACING LEAD WAS LIKELY THE CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE IMPLANTATION OF A TRANSCATHETER AORTIC VALVE, THE VALVE WAS DEPLOYED, AND THE PATIENT¿S PRESSURES WERE NOT IMPROVING. THE PHYSICIAN PERFORMED AN AORTIC ROOT CONTRAST INJECTION AND THERE WAS NO EXTRAVASATING CONTRAST, AND THE VALVE WAS IN A GOOD PLACE AND THERE WAS NO LEAKING AROUND THE VALVE. AN ECHOCARDIOGRAM WAS PERFORMED THAT REVEALED AN EFFUSION, THOUGH THE SOURCE WAS NOT IDENTIFIED, AND IT WAS SUSPECTED TO BE A VENTRICULAR PERFORATION FROM THE RIGHT VENTRICLE DUE TO THE TEMPORARY PACEMAKER. THE PATIENT¿S PRESSURES CONTINUED TO DROP, SO PERICARDIOCENTESIS AND 4 UNITS OF BLOOD WERE TRANSFUSED WHICH STABILIZED THE PATIENT¿S CONDITION. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU). SUBSEQUENTLY, THE PATIENT DIED LATER THAT DAY. PER THE PHYSICIAN, THE DEATH WAS NOT RELATED TO THE DEVICE, BUT THE DEATH WAS RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227217 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVOLUTFX-2329 0012318205 00763000365677

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Female Required Intervention| D SEE H11.