BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

    MDR report key: 23665651 · Received November 27, 2025

    Report

    Report Number
    2183870-2025-00552
    Event Type
    Malfunction
    Date Received
    November 27, 2025
    Date of Event
    November 7, 2025
    Report Date
    February 9, 2026
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    UDI-DI
    00821684060070
    PMA / PMN Number
    P110023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMAGE ANALYSIS TWO IMAGES WERE PROVIDED FOR EVALUATION IMAGE ONE IS OF THE BALLOON ON A RULER AND IT APPEARS TO MEASURE 60ML THE SECOND IMAGE IS OF THE STENT. THE FULL LENGTH OF THE SENT CANNOT BE SEEN IN THE IMAGE. 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

    IT WAS REPORTED THAT A STENT PRB35-07-060-120 PROTEGE EF V10 WAS USED DURING TREATMENT OF A SOFT TISSUE LESION WITH DISSECTION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (PROXIMAL LOCATION). THE LESION MEASURED 50MM IN LENGTH WITH AN ARTERY DIAMETER OF 6MM AND WAS C HARACTERIZED BY MINIMAL TORTUOSITY AND MINIMAL CALCIFICATION. A 6FR 45CM TERUMO DESTINATION WAS USED. A TERUMO 260CM ADVANTAGE WAS USED. VESSEL WAS PRE-DILATED WITH 6 X 200 EVERCROSS. VESSEL WAS POST-DILATED. MEASURED LESION WITH 7X60 BALLOON, DOCTOR REQUESTED 7 X 60 STENT, 7 X60X 120 EVERFLEX STENT WAS VERIFIED WITH SCRUB TECH AND GIVEN TO SCRUB TECH. STENT WAS PREPPED PER IFU AND ADVANCED TO LESION SITE TO EXTEND PREVIOUSLY DEPLOYED STENT AND DEPLOYED. PHYSICIAN NOTED THAT DEVICE DIDN'T LOOK LIKE A 60MM STENT. PUT IN THE 7 X 60 BALLOON TO COMPARE LENGTH OF BALLOON TO STENT LENGTH. UPON COMPARISON OF THE BALLOON WITH THE STENT THE PHYSICIAN SAID THE STENT CANNOT BE 60MM. STENT DEPLOYED WITHOUT ANY ISSUES. PHYSICIAN WOULD HAVE PREFERRED THE 60MM STENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2802260 PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN C098746 00821684060070

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male