BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 19344014 · Received May 17, 2024

    Report

    Report Number
    2025587-2024-02979
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    May 16, 2024
    Report Date
    May 17, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000017811
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID ENVPRO-16-US (LOT: 0011912665); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: (B)(6) 2024; EXPLANT DATE: (B)(6) 2024 PRODUCT ID L-ENVPRO-16-US (LOT: 0011912668); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID EVOLUTPRO-26-US (J131842); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2024; EXPLANT 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS 26 MILLIMETER (MM) TRANSCATHETER BIOPROSTHETIC VALVE INTO A PATIENT WITH SEVERE CALCIFICATION, THE VALVE COULD NOT BE DEPLOYED DUE TO THE VALVE FRAME. IT WAS DECIDED TO USE A 23 MM VALVE. DURING THE IMPLANT OF THE 23 MM VALVE, THE VALVE DISLODGED SO A SECOND 23 MM VALVE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970086 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-23-US 00763000017811

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention