BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX DCS

    MDR report key: 21026556 · Received December 27, 2024

    Report

    Report Number
    2025587-2024-07548
    Event Type
    Injury
    Date Received
    December 27, 2024
    Date of Event
    May 29, 2024
    Report Date
    March 5, 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
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: EVOLUTFX-23 (SERIAL: UNKNOWN); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: (B)(6) 2024. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN THE REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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

    ADDITIONAL REVIEW OF THE EVENT AND ADDITIONAL INFORMATION RECEIVED SHOWS THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. UPDATED DATA: B5. B6. D. SUSPECT MEDICAL DEVICE: EXPIRATION DATE, LOT#, AND UDI# H4. DEVICE MFG DATE H6. DEVICE CODE, EVAL CODE METHOD, EVAL CODE RESULT, AND EVAL CODE CONCLUSION WERE ALL UPDATED TO REFLECT THE EVENT NOT MEETING COMPLAINT CRITERIA. 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 THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A HEMORRHAGE AT THE ACCESS SITE WAS OBSERVED. FOL LOWING THE PROCEDURE, A NOSE BLEED WAS ALSO NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A HEMORRHAGE AT THE ACCESS SITE WAS OBSERVED. ADDITIONAL INFORMATION WAS RECEIVED TO REPORT VASCULAR ACCESS FOR DELIVERY CATHETER SYSTEM (DCS) INSERTION WAS ACHIEVED VIA THE PATIENT'S RIGHT SIDE WHICH WAS THE SAME SIDE AS THE INJURY. THE MINIMUM DIAMETER OF THE ACCESS VESSEL WAS 5.7×8.2. THE INJURY OCCURRED AT THE END OF THE PROCEDURE DUE TO THE NON-MEDTRONIC VASCULAR CLOSURE SYSTEM (PERCLOSE); HOWEVER, HEMOSTASIS WAS ALSO ACHIEVED USING A NON-MEDTRONIC VASCULAR CLOSURE SYSTEM (PERCLOSE). PER THE PHYSICIAN, THE DCS DID NOT CONTRIBUTE TO THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2513344 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVOLUTFX-2329 0012122836 00763000365677

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening