BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG

    MDR report key: 21607785 · Received March 14, 2025

    Report

    Report Number
    2183870-2025-00136
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    February 18, 2025
    Report Date
    March 14, 2025
    Manufacturer
    COVIDIEN
    Product Code
    NIP
    UDI-DI
    00821684060285
    PMA / PMN Number
    P110023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 PRB35-08-100-120 PROTEGE EF STENT V10 EXPERIENCED DEPLOYMENT ISSUES DURING A PROCEDURE INVOLVING THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). A 6FR NON-MEDTRONIC SHEATH WAS USED. THE DEVICE ENCOUNTERED MODERATE RESISTANCE WHEN BEING ADVANCED WITHIN THE PATIENT'S VASCULATURE. PARTIAL DEPLOYMENT AT THE TARGET SITE WAS REPORTED. THE PRODUCT WAS SUBSEQUENTLY SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW PRB35-08-040-120 PROTEGE EVERFLEX STENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1547665 PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG STENT, SUPERFICIAL FEMORAL ARTERY NIP COVIDIEN B776866 00821684060285

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male