BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSYS CATHETER

    MDR report key: 12605378 · Received October 11, 2021

    Report

    Report Number
    3014251914-2021-00003
    Event Type
    Injury
    Date Received
    October 11, 2021
    Date of Event
    February 3, 2021
    Report Date
    October 11, 2021
    Manufacturer
    AVENU MEDICAL
    Product Code
    PQK
    PMA / PMN Number
    K191114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: COMPARISON OF SURGICAL VERSUS PERCUTANEOUSLY CREATED ARTERIOVENOUS HEMODIALYSIS FISTULAS AUTHOR: GHAZI HARIKA, ALEXANDROS MALLIOS, MAHMOUD ALLOUACHE JOURNAL: JOURNAL OF VASCULAR SURGERY YEAR: 2021 VOL/ISSUE: 74(1) REF: 10.1016/J.JVS.2020.12.086. AGE: AVERAGE AGE. SEX: MAJORITY GENDER. DATE OF EVENT: DATE OF PUBLICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS SUBMITTED DETAILING A SINGLE-CENTER RETROSPECTIVE COMPARATIVE STUDY TO COMPARE THE RESULTS BETWEEN PERCUTANEOUS ARTERIOVENOUS FISTULAS (PAVFS) CREATED WITH THE ELLIPSYS DEVICE. 107 PATIENTS UNDERWENT P-AVF CREATION WITH THE ELLIPSYS SYSTEM, AND AN EQUAL NUMBER OF PATIENT¿S UNDERWENT SURGICAL ARTERIOVENOUS FISTULAS (S-AVFS) CREATION. THE PRIMARY ENDPOINTS INCLUDED THE MATURATION AND PATENCY RATES. THE SECONDARY ENDPOINTS WERE REINTERVENTION, RISK OF INFECTION, AND THE INCIDENCE OF STEAL SYNDROME AND ANEURYSM FORMATION. THE MATURATION RATE AT 6 WEEKS WAS HIGHER FOR THE PAVFS. NO SIGNIFICANT DIFFERENCES WERE FOUND BETWEEN THE P-AVFS AND ELBOW SURGICAL ARTERIOVENOUS FISTULA (E-AVFS). NO SIGNIFICANT DIFFERENCES WERE FOUND IN THE SECONDARY PATENCY RATES AT 12 (90% VS 91%) AND 24 (88% VS 91%) MONTHS. AT 12 MONTHS, THE PATIENTS WITH A P-AVF HAD REQUIRED MORE SECONDARY PERCUTANEOUS INTERVENTIONS THAN HAD PATIENTS WITH AN S-AVF (41% VS 4%) BUT FEWER OPEN SURGICAL INTERVENTIONS. AT 24 MONTHS, THE S-AVF AND P-AVF GROUPS HAD UNDERGONE A SIMILAR PROPORTION OF PERCUTANEOUS INTERVENTIONS (42% VS 53%).HOWEVER, THE S-AVF GROUP HAD MAINTAINED THE MORE FREQUENT REQUIREMENT FOR OPERATIVE INTERVENTIONS (36% VS 17%). A COMPARISON OF P-AVFS AND E-AVFS SHOWED NOTABLE DIFFERENCES AT 6 MONTHS IN THE REQUIREMENT FOR PERCUTANEOUS AND SURGICAL (12% VS 40%) INTERVENTIONS (INCLUDING SUPERFICIALIZATION). AT 24 MONTHS, THE E-AVFS HAD CONTINUED TO REQUIRE A GREATER RATE OF SURGICAL REVISION (49% VS 18%). WOUND HEALING ISSUES AND INFECTIONS WERE HIGHER FOR THE S-AVF GROUP (9% VS 0.9%). ONE PATIENT WITH A P-AVF HAD EXPERIENCED WOUND SEPARATION AFTER SUPERFICIALIZATION. THE AUTHORS CONCLUDED AVFS CREATED PERCUTANEOUSLY WITH THE ELLIPSYS SYSTEM HAD BETTER MATURATION AND PATENCY RATES SIMILAR TO THOSE OF S-AVFS CONSTRUCTED BY AN EXPERIENCED VASCULAR SURGERY GROUP WITH EXCELLENT SURGICAL OUTCOMES. THE ELLIPSYS CREATED P-AVFS HAD A LOWER RISK OF INFECTION, HAIDI, AND ANEURYSM FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506825 ELLIPSYS CATHETER PERCUTANEOUS CATHETER FOR CREATION OF AN ARTER PQK AVENU MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention