BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

    MDR report key: 6881341 · Received September 20, 2017

    Report

    Report Number
    2183870-2017-00408
    Event Type
    Injury
    Date Received
    September 20, 2017
    Date of Event
    May 25, 2017
    Report Date
    August 21, 2017
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K060057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE IS LITERATURE ARTICLE PUBLISHED DATE BALLOON ANGIOPLASTY WITH SELECTIVE STENTING STRATEGY IN TREATMENT OF HEMODIALYSIS RELATED CENTRAL VEIN OCCLUSIVE LESIONS INTERNATIONAL ANGIOLOGY (2017) VOL 36, NO.5 - 462-466 DOI: 10.23736/S0392-9590.17.03817-2. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE AIM OF THIS STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF BALLOON ANGIOPLASTY AND SELECTIVE STENTING IN TREATMENT OF SYMPTOMATIC CENTRAL VEIN OCCLUSIVE LESIONS (CVOL) IN PATIENTS WITH UPPER EXTREMITY HEMODIALYSIS ACCESS. THIS STUDY COMPRISED OF 74 PATIENTS WITH SYMPTOMATIC CVOL UNDERWENT ENDOVASCULAR THERAPY. FIFTY FOUR % OF THE POPULATION WAS MALE WITH A MEAN AGE OF 49.7 YEARS. OF THE 74 PATIENTS, VENOGRAPHY SHOWED 29 CASES OF COMPLETE OCCLUSION AND 45 STENOTIC LESIONS. 29 LESIONS WERE LOCATED ON THE RIGHT SIDE AND 46 ON LEFT SIDE. VEIN LOCATION OF THESE LESIONS WAS AUXILIARY VEIN (4), SUBCLAVIAN VEIN (27) AND BRACHIOCEPHALIC VEIN (43). IN 11 CASES, THE OCCLUDED SEGMENT COULD NOT BE TRAVERSED. FOR THE REMAINING 63 PATIENTS; PTA ALONE WAS CARRIED OUT IN 46 CASES AND BARE METAL STENTING WAS PERFORMED IN 17 PATIENTS. SYMPTOMATIC IMPROVEMENT WAS REPORTED IN ALL THE PATIENTS WITH NO MAJOR PERIPROCEDURAL MORBIDITY OR MORTALITY EXCEPT PUNCTURE SITE EXTRAVASATION (6 PATIENTS), NONE OF WHICH REQUIRED SURGICAL INTERVENTION. FIVE PATIENTS WERE LOST TO FOLLOW-UP WITHIN THE ONE YEAR FOLLOW-UP PERIOD. REPEATED INTERVENTIONS WERE CARRIED OUT WHEN SYMPTOMS RECURRED. PATIENTS WITH RECURRENT SYMPTOMS WERE TREATED WITH REPEAT BALLOON ANGIOPLASTY, AND TWO PATIENTS HAD STENT PLACEMENT. PTA WAS THE INITIAL TREATMENT OPTION FOR CVOL WITH REPORTED TECHNICAL SUCCESS OF 85.1% AND 73% FOR THOSE PATIENTS TREATED WITH BALLOON ANGIOPLASTY ALONE. IN THE CURRENT STUDY, STENTS WERE PLACED IN 17 (27%) PATIENTS. STENTS WERE DEPLOYED IN CASE OF RESIDUAL STENOSIS >50% OR RECURRENCE WITHIN 3 MONTHS FOLLOWING BALLOON ANGIOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660217 PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention