BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

    MDR report key: 22962097 · Received September 4, 2025

    Report

    Report Number
    2183870-2025-00425
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    January 30, 2025
    Report Date
    September 4, 2025
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    P110023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPARISON OF THE RISK SCORING SYSTEMS IN LONG TERM RESTENOSIS DUE TO PERCUTANEOUS INTERVENTIONS TO THE SUPERFICIAL FEMORAL ARTERY VASA (2025), 54 (3), 184¿191 2025 HOGREFE HTTPS://DOI.ORG/10.1024/0301-1526/A001178 A2 AVERAGE AGE A3 MAJORITY GENDER B3 DATE OF PUBLICATION 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

    LITERATURE WAS REVIEWED REGARDING: THE COMPARISON OF THE EFFICACIES OF CHA2DS2-VASC, CHA2DS2-VASC-HS, ATRIA, ATRIA-HSV, AND HATCH RISK SCORING SYSTEMS IN PREDICTING LONG-TERM (5 YEARS) RESTENOSIS DUE TO PERCUTANEOUS INTERVENTIONS TO THE SUPERFICIAL FEMORAL ARTERY (PAGE 184). THE TIME FRAME OF THIS STUDY WAS: (B)(6) 2014 TO (B)(6) 2022. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: PROTEGE EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM. PATIENT ADVERSE EVENTS INCLUDED: LONG-TERM RESTENOSIS OF THE SUPERFICIAL FEMORAL ARTERY (SFA), DEFINED AS >50% GRADE OF OBSTRUCTION BY PERIPHERAL ANGIOGRAPHY OR >2.4 PEAK SYSTOLIC VELOCITY INDEX RATIO BY DUPLEX SCAN. INCREASED RATES OF RESTENOSIS ASSOCIATED WITH HIGH PROTEINURIA, HIGH HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) VALUES, AND LOW EJECTION FRACTION (EF) VALUES. ADVERSE EFFECTS OF HYPERTENSION (HT), DIABETES MELLITUS (DM), SMOKING, AND HYPERLIPIDEMIA (HPL) ON RESTENOSIS. HIGHER TRANSATLANTIC INTER-SOCIETY CONSENSUS (TASC-II) AND RUTHERFORD CLASSIFICATIONS LINKED TO SEVERE PERIPHERAL VASCULAR ANATOMICAL FEATURES AND SYMPTOMATIC PRESENTATIONS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2255706 PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COVIDIEN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention