BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

    MDR report key: 21534319 · Received March 6, 2025

    Report

    Report Number
    2183870-2025-00110
    Event Type
    Malfunction
    Date Received
    March 6, 2025
    Date of Event
    February 21, 2025
    Report Date
    May 2, 2025
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    P110023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS THE DEVICE WAS RETURNED WITH THE LOCKING MECHANISM WAS LOOSENED AND A PORTION OF THE STENT WAS OBSERVED TO BE EXPOSED, THE STENT WAS CONFIRMED AS 60MM FROM THE STRAIN RELIEF, APPROX 13MM OF THE STENT WAS EXPOSED FROM THE DEVICE, AND THE GOLD COLOURED INNER APPEARED TO BE KINKED, A GUIDEWIRE COULD NOT PASS THE KINKED SECTION OF THE GOLD INNER. THE DEPLOYMENT PADDLES ARE APPROXIMATELY 79MM APART THE STENT WAS MANUALLY DEPLOYED AND THE DISTAL END OF THE STENT WAS DAMAGED, THE DISTAL INNER ASSEMBLY WAS CUT JUST PROXIMAL TO THE STENT RETAINER TO ALLOW FURTHER TESTING. WITNESS MARKS WERE NOTED ON THE STAINLESS STEEL HYPOTUBE APPROXIMATELY 25MM AND 27MM FROM THE DISTAL END OF THE STAINLESS STEEL HYPOTUBE, INDICATING THAT THE SAFETY LOCKING PIN WAS TIGHTENED IN MANUFACTURING. 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 A STENT PROCEDURE INVOLVING THE STENT PROTEGE EF ALONG WITH A 6F NON- MEDTRONIC SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE, THERE WERE SIGNIFICANT PROCEDURAL ISSUES. THE PROCEDURE WAS CONDUCTED ON THE RIGHT SUPERFICIAL FEMORAL ARTERY, WHICH HAD A CHRONIC TOTAL OCCLUSION WITH A LESION LENGTH OF 52 MILLIMETERS AND AN ARTERY DIAMETER OF 5.6 MILLIMETERS. THE LESION WAS CALCIFIED, FIBROUS, AND CONTAINED PLAQUE AND LITTLE CALCIFICATION. THE LESION WAS PREDILATED WITH A BALLOON. DURING THE PROCEDURE THE STENT WAS DELIVERED TO THE LESION SITE AND THE LOCK-PIN WAS REMOVED AND PREPARED. THE CATHETER DELIVERY RESISTANCE WAS VERY LARGE, AND THE MIDDLE DELIVERY CATHETER OF THE DELIVERY TIP WAS TWISTED, LEADING TO DEPLOYMENT ISSUES. THE SURGEON STOPPED THE DEPLOYMENT, REMOVED THE ENTIRE DELIVERY DEVICE, AND REPLACED IT WITH THE SAME MODEL, PRP35-06-060-120, WHICH WAS SUCCESSFULLY DEPLOYED, COMPLETING THE SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535423 PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN B772809

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male