BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX DCS

    MDR report key: 19880963 · Received August 1, 2024

    Report

    Report Number
    2025587-2024-04379
    Event Type
    Injury
    Date Received
    August 1, 2024
    Date of Event
    July 30, 2024
    Report Date
    August 22, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME EVOLUT FX VALVE; PRODUCT ID EVOLUTFX-26 (SERIAL: (B)(6)); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2024. 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 A PRE-DILATION WAS PERFORMED USING A VACS 18MM BALLOON. RIGHT FEMORAL ACCESS WAS USED WITH A SAFARI XS GUIDEWIRE, TO IMPLANT THE VALVE INTO THE PATIENT'S NATIVE ANNULUS. CUSPAL OVERLAP TECHNIQUE WAS USED, AND TRAINING GUIDANCE FOR SLOW DEPLOYMENT OF THE VALVE WAS FOLLOWED. PRIOR TO SLOWLY WITHDRAWING THE DELIVERY CATHETER SYSTEM (DCS), THE NOSE CONE WAS SUCCESSFULLY CENTERED WITHIN THE FRAME INFLOW BY SLIGHTLY RETRACTING THE GUIDEWIRE, HOWEVER THE VALVE GRADUALLY ROSE WHEN REMOVING THE DCS. THE DCS WAS NOT TWISTED OR TORQUED AT ANY POINT DURING DEPLOYMENT. PER THE PHYSICIAN, THE CAUSE OF THE DISLODGEMENT WAS POOR DILATION. IT WAS POSSIBLE THAT POOR DILATION WAS CAUSED BY THE BICUSPID VALVE. THE INFLOW LCC SIDE TO BECAME NARROWED, RESULTING IN VALVE DISLODGEMENT.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT HAD A BICUSPID VALVE WITH A RIGHT CORONARY CUSP (RCC)-LEFT CORONARY CUSP (LCC) RAPHE AND EXTENSIVE BULKY CALCIFICATION ON THE RCC CUSP. DURING THE FIRST POINT OF NO RECAPTURE, THE VALVE WAS NARROWED, SO IT WAS RECAPTURED AND PLACED DEEPER. SINCE THE DEPTH WAS NOT AN ISSUE, THE VALVE WAS FULLY RELEASED. HOWEVER, AS THE PADDLES DETACHED, THE NON-CORONARY CUSP (NCC) SIDE POPPED UP BY ABOUT 3MM, AND WHEN REMOVING THE NOSE CONE, THE VALVE SLIPPED OFF THE CUSPS. A SNARE WAS USED TO GRAB THE VALVE PADDLES AND PULL THEM UP ABOVE THE SINOTUBULAR JUNCTION (STJ). A SECOND VALVE WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188332 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVOLUTFX-2329 0012128103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention