BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX DCS

    MDR report key: 19132481 · Received April 18, 2024

    Report

    Report Number
    2025587-2024-02329
    Event Type
    Injury
    Date Received
    April 18, 2024
    Date of Event
    April 5, 2024
    Report Date
    May 13, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10:  PRODUCT ID L-EVOLUTFX-2329 (LOT: 0012033757); PRODUCT TYPE: 0195-HEART VALVES PRODUCT ID EVOLUTFX-29 (J120954); 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. 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

    MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, DURING VENTRICULAR WIRE REPLACEMENT THE TIP OF THE NON-MEDTRONIC (SAFARI) WIRE WAS PERFORATING THE POSTERIOR WALL OF THE APEX OF THE LEFT VENTRICLE, BUT WAS UNNOTICED. AFTER DELIVERY CATHETER SYSTEM (DCS) INSERTION, THE FIRST DEPLOYMENT WAS PERFORMED. AT 80% DEPLOYMENT, BLOOD PRESSURE DID NOT RETURN WELL, SO A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED. PERICARDIAL EFFUSION WAS OBSERVED. THE DCS WAS REMOVED. PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) AND PERICARDIAL DRAINAGE WERE PERFORMED. DURING THORACOTOMY, THE DAMAGE TO THE POSTERIOR WALL OF THE LEFT VENTRICULAR APEX WAS REPAIRED. THE CAUSE OF THE DAMAGE WAS WHEN THE PRE-IMPLANT BALLOON OR THE DCS WAS INSERTED AND MANIPULATED OVER THE WIRE DURING PERFORATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT PER THE PHYSICIAN, THE NON-MEDTRONIC GUIDEWIRE CAUSED THE INJURY. ADDITIONALLY, THE DCS POS SIBLY CONTRIBUTED TO THE INJURY BECAUSE THE DCS HAD BEEN THREADED THROUGH THE WIRE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499161 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVOLUTFX-2329 0012050580

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L SEE H11...