BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIDA BRECKER CURVE GUIDEWIRE

    MDR report key: 22385662 · Received July 2, 2025

    Report

    Report Number
    2025587-2025-04746
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    June 8, 2023
    Report Date
    July 2, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DQX
    PMA / PMN Number
    K132623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID EVOLUTFX-29 (F252019); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2023; PRODUCT ID D-EVOLUTFX-2329; LOT/SERIAL NUMBER: UNKNOWN; PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE N/A; EXPLANT DATE N/A. 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 PROCEDURE, FOLLOWING DEPLOYMENT, THE PATIENT WAS HYPOTENSIVE. MEDICATION WAS ADMINISTERED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED TO CIRCULATE THE MEDICATION. THE PATIENT WAS MOVED TO THE INTENSIVE CARE UNIT (ICU) AND SUBSEQUENTLY STARTED DECOMPENSATING. IT WAS NOTED THAT THE PATIENT HAD A LEFT VENTRICLE PERFORATION THAT HAD RESULTED IN PERICARDIAL EFFUSION. IT WAS REPORTED THAT THE GUIDEWIRE HAD CAUSED THE PERFORATION. THE TYPE OF GUIDEWIRE WAS UNKNOWN. SURGICAL INTERVENTION WAS PERFORMED TO REPAIR THE LEFT VENTRICLE. FOLLOWING SURGERY, THE PATIENT RETURNED TO THE ICU. LATER THAT DAY, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177624 CONFIDA BRECKER CURVE GUIDEWIRE WIRE, GUIDE, CATHETER DQX MEDTRONIC HEART VALVES DIVISION GWBC30

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Required Intervention SEE H11...