BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIDA BRECKER CURVE GUIDEWIRE

    MDR report key: 22152259 · Received June 5, 2025

    Report

    Report Number
    2025587-2025-04085
    Event Type
    Injury
    Date Received
    June 5, 2025
    Date of Event
    May 14, 2025
    Report Date
    July 10, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DQX
    PMA / PMN Number
    K132623
    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 EVOLUTFX-26 (K060221); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2025; EXPLANT DATE 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. 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

    UPDATED DATA: B2. B5. H6. 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, AFTER VALVE PLACEMENT, A DROP IN BLOOD PRESSURE WAS OBSERVED. PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) WAS INTRODUCED DUE TO THE HYPOTENSION AND THE HEMODYNAMICS STABILIZED. THE CAUSE OF THE HYPOTENSION WAS LIKELY DUE TO LOW FLOW LOW GRADIENT SEVERE AORTIC STENOSIS, WHERE THE BLOOD FLOW OUTPUT POST-VALVE PLACEMENT WAS INSUFFICIENT MAKING LEAFLET COAPTATION DIFFICULT. ADDITIONALLY, THE LEFT VENTRICLE GUIDEWIRE PRESSED AGAINST THE VALVE LEAFLETS. THIS LIKELY CAUSED AN INCREASE IN AORTIC REGURGITATION AND CONTRIBUTED TO THE HYPOTENSION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE TYPE OF AORTIC REGURGITATION WAS CENTRAL AND THE SEVERITY WAS SEVERE. ONCE THE GUIDEWIR E WAS REMOVED, THE PATIENT'S SYMPTOMS IMPROVED. TREATMENT WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71466 CONFIDA BRECKER CURVE GUIDEWIRE WIRE, GUIDE, CATHETER DQX MEDTRONIC HEART VALVES DIVISION GWBC30

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R SEE H11...