BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

    MDR report key: 24349371 · Received February 16, 2026

    Report

    Report Number
    2183870-2026-00077
    Event Type
    Injury
    Date Received
    February 16, 2026
    Date of Event
    January 20, 2026
    Report Date
    February 16, 2026
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    UDI-DI
    00821684060247
    PMA / PMN Number
    P110023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    IT WAS REPORTED THAT THE STENT PRB35-08-060-120 PROTEGE EF V10 FRACTURED DURING A PROCEDURE. THE PHYSICIAN SNARED OUT THE FRACTURED STENT AND USED ANOTHER STENT ON THAT AREA THAT NEEDED STENTED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412388 PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COVIDIEN C187528 00821684060247

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention