BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX DCS

    MDR report key: 22510191 · Received July 15, 2025

    Report

    Report Number
    2025587-2025-05026
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    June 18, 2025
    Report Date
    October 20, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NPT
    UDI-DI
    00763000365677
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: EVFXPLUS-26, (SERIAL: (B)(6)); PRODUCT TYPE: 0195-HEART VALVES; 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    UPDATED B.5 AND H.6. 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 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

    IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE INVOLVING THE TRANSCATHETER AORTIC VALVE EVFXPLUS-26, THE PATIENT EXPERIENCED SEVERE HYPERTENSION WITH A BLOOD PRESSURE OF 250/170 MM HG. AFTER ADMINISTRATION OF ANTIHYPERTENSIVES, THE PATIENT DEVELOPED HYPOTENSION, WHICH WAS MANAGED WITH A NOREPINEPHRINE DRIP. A PRE-BALLOON AORTIC VALVULOPLASTY WAS PERFORMED WITH A 20 MM NON-MEDTRONIC BALLOON DUE TO CALCIFICATION IN THE SINOTUBULAR JUNCTION. . THE DELIVERY CATHETER SYSTEM (DCS) WAS INTRODUCED WITH EASE THROUGH THE RIGHT FEMORAL ARTERY (RFA) AND TRAVERSED THE AROUND THE AORTIC ARCH WITHOUT DIFFICULTY. DURING DCS ADVANCEMENT, THE PATIENT REMAINED HYPOTENSIVE AND BECAME UNRESPONSIVE. A NEUROLOGICAL ASSESSMENT WAS PERFORMED. THE PATIENT EXHIBITED LEFT-SIDED WEAKNESS, MOVING THE RIGHT SIDE BUT NOT THE LEFT FOR SOME TIME. AN ECHOCARDIOGRAM WAS CONDUCTED AND NO EFFUSION WAS OBSERVED. OF NOTE, A GROIN COMPLICATION WAS IDENTIFIED IN THE RFA AFTER REMOVAL OF THE DELIVERY SYSTEM. THE STROKE TEAM WAS NOTIFIED AND THE PAT IENT WAS MONITORED. THE PATIENT SUBSEQUENTLY FOLLOWED COMMANDS AND RESPONDED WITH ALL EXTREMITIES, WITH THE RIGHT SIDE MORE BRISK TO RESPOND THAN THE LEFT. THE PHYSICIAN ASSESSED THAT THE PROCEDURE CAUSED OR CONTRIBUTED TO THE SYMPTOMS, BUT THE MEDTRONIC DEVICE DID NOT. A STROKE WAS SUSPECTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT AN ISCHEMIC STROKE WAS CONFIRMED VIA MAGNETIC RESONANCE IMAGING (MRI). PER THE PHYSICIAN, IT IS UNKNOWN WHAT THE CAUSE OF THE STROKE WAS. THE PATIENT'S CALCIFIED ANATOMY CONTRIBUTED TO THE STROKE. THE VASCULAR INJURY OCCURRED AT THE RIGHT FEMORAL ARTERY, WHICH WAS THE ACCESS SITE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WENT TO A REHABILITATION FACILITY IN RESULT OF THE STROKE. THE VASCULAR INJURY WAS DESCRIBED AS EXTRAVASATION, AND A STENT WAS PLACED AS TREATMENT. PER THE PHYSICIAN, THE CAUSE THE VASCULAR INJURY WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146185 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC IRELAND D-EVOLUTFX-2329 0012783990 00763000365677

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention| L