BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

    MDR report key: 6344985 · Received February 21, 2017

    Report

    Report Number
    2183870-2017-00078
    Event Type
    Injury
    Date Received
    February 21, 2017
    Date of Event
    January 1, 2017
    Report Date
    January 25, 2017
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K060057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AVERAGE AGE OF PATIENTS;MAJORITY GENDER; DATE JOURNAL WAS PUBLISHED ARTICLE DETAILS: TITLE: DIRECT STENTING IN PATIENTS WITH ACUTE LOWER LIMB ARTERIAL OCCLUSIONS: IMMEDIATE AND LONG-TERM RESULTS JOURNAL: CARDIOVASCULAR INTERVENTION RADIOLOGY YEAR: 2017 VOL: 40 PGS: 192 ¿ 201 CARDIOVASC INTERVENT RADIOL (2017) 40:192¿201 DOI 10.1007/S00270-016-1500-5.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SIXTEEN PATIENTS WERE ENROLLED IN THE STUDY. THE COMMON ILIAC ARTERY, EXTERNAL ILIAC ARTERY, SFA AND POPLITEAL ARTERIES WERE TREATED. IN ALL PATIENTS, THE OCCLUSIONS WERE EASILY TRAVERSED INTRALUMINALLY WITH STRAIGHT TYPE HYDROPHILIC GUIDE WIRES, A SIGN STRONGLY PREDICTING THE PRESENCE OF SOFT THROMBUS. SUBSEQUENTLY, COMPLETE SE, MARIS AND PROTEGE STENTS WERE IMPLANTED. DURING THE FIRST WEEK AFTER THE PROCEDURE, THERE WAS ONE CASE OF IN-STENT THROMBOSIS FOLLOWED BY ABOVE-KNEE AMPUTATION. FOUR PATIENTS DIED DURING FOLLOW UP, DUE TO NON-PROCEDURE RELATED CAUSES (COLON CANCER, BREAST CANCER, MYOCARDIAL INFARCTION, ISCHEMIC STROKE) AND THERE WERE TWO MINOR (TOE) AMPUTATIONS AND ONE MAJOR (ABOVE-KNEE) AMPUTATION. PURPOSE: THE PURPOSE OF THIS STUDY IS TO ACCENTUATE THE EFFICACY OF DIRECT STENTING (STENT PLACEMENT WITHOUT PREDILATATION OF THE LESION) IN PATIENTS WITH ACUTE LOWER LIMB ARTERIAL ISCHEMIA (ALLI). MATERIALS AND METHODS: BETWEEN JANUARY 2010 AND SEPTEMBER 2015, 16 PATIENTS (11 MEN AND 5 WOMEN) UNDERWENT DIRECT STENTING OF ACUTE ARTERIAL OCCLUSIONS. ALL PATIENTS HAD CONTRAINDICATION FOR SURGICAL REVASCULARIZATION OR CATHETER-DIRECTED THROMBOLYSIS. ACCORDING TO SVS/ISCVS CLASSIFICATION, SIX PATIENTS HAD IIA AND TEN PATIENTS IIB ALLI. THE OCCLUSIONS WERE LOCATED IN CIA, EIA, SFA, OR POPLITEAL ARTERY. MEAN FOLLOW-UP TIME WITH CLINICAL EXAMINATION AND COLOR DUPLEX ULTRASONOGRAPHY WAS 37.6 MONTHS (RANGE 1¿72). WE ANALYZED THE TECHNICAL AND CLINICAL OUTCOMES OF THE PROCEDURES, AS WELL THE COMPLICATIONS AND PATENCY RATES. RESULTS: TECHNICAL SUCCESS WAS ACHIEVED IN ALL PATIENTS (16/16) AND THERE WAS SIGNIFICANT CLINICAL IMPROVEMENT IN 15 PATIENTS. THERE WAS NEITHER DISTAL EMBOLIZATION NOR PROCEDURE-RELATED COMPLICATIONS. DURING FOLLOW-UP, FOUR PATIENTS DIED DUE TO NON-PROCEDURE-RELATED CAUSES (COLON CANCER, BREAST CANCER, MYOCARDIAL INFARCTION, ISCHEMIC STROKE) AND THERE WERE TWO MINOR (TOE) AMPUTATIONS AND ONE MAJOR (ABOVE-KNEE) AMPUTATION. CONCLUSIONS DIRECT STENTING MAY BE A VALUABLE ALTERNATIVE PROCEDURE FOR ACUTE ARTERIAL OCCLUSIONS IN SELECTED CASES WITH HIGH TECHNICAL SUCCESS AND SIGNIFICANT CLINICAL IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127331 PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 DA Required Intervention