BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

    MDR report key: 23497321 · Received November 7, 2025

    Report

    Report Number
    2183870-2025-00514
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    March 23, 2023
    Report Date
    November 7, 2025
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    P110023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OBJECTIVE: PACLITAXEL DRUG-COATED BALLOON (PDCB) ANGIOPLASTY HAS BEEN SHOWN TO BE AN EFFECTIVE TREATMENT OF IN-STENT RESTENOSIS (ISR) AT THE FEMOROPOPLITEAL (FP) ARTERIES. LONG-TERM STUDIES, HOWEVER, HAVE SHOWN A PROGRESSIVE DECREASE IN THE PATENCY RATES FOLLOWING PDCB. THE AIM OF THIS STUDY WAS TO DETERMINE THE PREDICTORS OF STENOSIS RECURRENCE AFTER PDCB TREATMENT OF FP-ISR, AND ITS IMMEDIATE AND MID-TERM OUTCOMES. METHODS: THIS PROSPECTIVE, NON-RANDOMIZED STUDY INCLUDED ALL CHRONIC LOWER EXTREMITY ISCHEMIA PATIENTS OF RUTHERFORD CLASS 3¿6 WHO UNDERWENT PDCB ANGIOPLASTY TO TREAT >50% FP-ISR BETWEEN JUNE 2017 AND DECEMBER 2019. THE PRIMARY ENDPOINT WAS PRIMARY PATENCY, DEFINED AS FREEDOM FROM BINARY RESTENOSIS AND FREEDOM FROM CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION (CD-TLR) AT 12 MONTHS. SECONDARY ENDPOINTS INCLUDED 12-MONTHS FREEDOM FROM CD-TLR AND MAJOR ADVERSE EVENTS (MAES). RESULTS: A TOTAL OF 73 SYMPTOMATIC CHRONIC LIMB ISCHEMIA PATIENTS (73 LIMBS INCLUDING 63 WITH LIMB THREATENING ISCHEMIA) UNDERWENT PDCB ANGIOPLASTY OF FP-ISR LESIONS (13.7% TOSAKA CLASS I, 54.8% CLASS II, AND 31.5% CLASS III). THE MEAN ISR LESION LENGTH WAS 121.8 ± 52.7 MM. TECHNICAL SUCCESS WAS ACHIEVED IN 70 (95.9%) PATIENTS. KAPLAN¿MEIER ESTIMATE OF THE 12- MONTHS RATES OF PRIMARY PATENCY AND FREEDOM FROM CD-TLR WAS 76.1% AND 87.4%, RESPECTIVELY. AT ONE YEAR, MAES OCCURRED IN EIGHT PATIENTS (11.0%) INCLUDING TWO DEATHS (2.7%), ONE MAJOR AMPUTATION (1.4%), AND SIX (8.2%) SURGICAL REVASCULARIZATIONS. MULTIVARIABLE ANALYSIS SHOWED THAT TOSAKA CLASS III ISR (HR 4.51, CI: 1.31¿15.53, P <(><<)> 0.001) AND REFERENCE VESSEL DIAMETER (HR 0.38, 95% CI: 0.18¿080, P = 0.01) WERE INDEPENDENTLY ASSOCIATED WITH RECURRENT ISR. CONCLUSIONS: PDCB IS SAFE AND EFFECTIVE TREATMENT OF FP-ISR LESIONS. OCCLUSIVE ISR LESIONS AND REFERENCE VESSEL DIAMETER WERE INDEPENDENTLY ASSOCIATED WITH RECURRENT ISR STENOSIS AFTER PDCB TREATMENT.

    Description of Event or Problem · 0

    OBJECTIVE: PACLITAXEL DRUG-COATED BALLOON (PDCB) ANGIOPLASTY HAS BEEN SHOWN TO BE AN EFFECTIVE TREATMENT OF IN-STENT RESTENOSIS (ISR) AT THE FEMOROPOPLITEAL (FP) ARTERIES. LONG-TERM STUDIES, HOWEVER, HAVE SHOWN A PROGRESSIVE DECREASE IN THE PATENCY RATES FOLLOWING PDCB. THE AIM OF THIS STUDY WAS TO DETERMINE THE PREDICTORS OF STENOSIS RECURRENCE AFTER PDCB TREATMENT OF FP-ISR, AND ITS IMMEDIATE AND MID-TERM OUTCOMES. METHODS: THIS PROSPECTIVE, NON-RANDOMIZED STUDY INCLUDED ALL CHRONIC LOWER EXTREMITY ISCHEMIA PATIENTS OF RUTHERFORD CLASS 3¿6 WHO UNDERWENT PDCB ANGIOPLASTY TO TREAT >50% FP-ISR BETWEEN JUNE 2017 AND DECEMBER 2019. THE PRIMARY ENDPOINT WAS PRIMARY PATENCY, DEFINED AS FREEDOM FROM BINARY RESTENOSIS AND FREEDOM FROM CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION (CD-TLR) AT 12 MONTHS. SECONDARY ENDPOINTS INCLUDED 12-MONTHS FREEDOM FROM CD-TLR AND MAJOR ADVERSE EVENTS (MAES). RESULTS: A TOTAL OF 73 SYMPTOMATIC CHRONIC LIMB ISCHEMIA PATIENTS (73 LIMBS INCLUDING 63 WITH LIMB THREATENING ISCHEMIA) UNDERWENT PDCB ANGIOPLASTY OF FP-ISR LESIONS (13.7% TOSAKA CLASS I, 54.8% CLASS II, AND 31.5% CLASS III). THE MEAN ISR LESION LENGTH WAS 121.8 ± 52.7 MM. TECHNICAL SUCCESS WAS ACHIEVED IN 70 (95.9%) PATIENTS. KAPLAN¿MEIER ESTIMATE OF THE 12- MONTHS RATES OF PRIMARY PATENCY AND FREEDOM FROM CD-TLR WAS 76.1% AND 87.4%, RESPECTIVELY. AT ONE YEAR, MAES OCCURRED IN EIGHT PATIENTS (11.0%) INCLUDING TWO DEATHS (2.7%), ONE MAJOR AMPUTATION (1.4%), AND SIX (8.2%) SURGICAL REVASCULARIZATIONS. MULTIVARIABLE ANALYSIS SHOWED THAT TOSAKA CLASS III ISR (HR 4.51, CI: 1.31¿15.53, P <(><<)> 0.001) AND REFERENCE VESSEL DIAMETER (HR 0.38, 95% CI: 0.18¿080, P = 0.01) WERE INDEPENDENTLY ASSOCIATED WITH RECURRENT ISR. CONCLUSIONS: PDCB IS SAFE AND EFFECTIVE TREATMENT OF FP-ISR LESIONS. OCCLUSIVE ISR LESIONS AND REFERENCE VESSEL DIAMETER WERE INDEPENDENTLY ASSOCIATED WITH RECURRENT ISR STENOSIS AFTER PDCB TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781325 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 65 YR Unknown Required Intervention