BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE ACUSEAL VASCULAR GRAFT

    MDR report key: 7934960 · Received October 4, 2018

    Report

    Report Number
    2017233-2018-00583
    Event Type
    Injury
    Date Received
    October 4, 2018
    Date of Event
    May 1, 2018
    Report Date
    September 10, 2018
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K130215
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS NO LOT NUMBER INFORMATION WAS PROVIDED. THE DEVICES WERE NOT RETURNED. CONSEQUENTLY, DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. ADDITIONAL INFORMATION ABOUT THESE EVENTS COULD NOT BE OBTAINED. AS A RESULT, NO FURTHER INVESTIGATION IS POSSIBLE. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING AND TRENDING. NOTE: NO ACTUAL EVENT DATE WAS PROVIDED. THEREFORE, DATE OF EVENT IS AN ESTIMATE BASED ON PUBLICATION DATE OF THE ARTICLE. NOTE: NO ACTUAL PATIENT AGE WAS PROVIDED. THEREFORE, AGE AT TIME OF EVENT IS AN ESTIMATE BASED ON THE AVERAGE AGE IDENTIFIED IN THE ARTICLE. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED THROUGH LITERATURE REVIEW: T, ABE., ET AL (MAY, 2018). "TREATMENT RESULTS USING GORE® ACUSEAL VASCULAR GRAFT." THE JAPANESE JOURNAL OF PHLEBOLOGY. 29 (2). 261. FROM APRIL, 2016 TO JANUARY, 2018, 32 PATIENTS UNDERWENT ARTERIO-VENOUS SHUNT PROCEDURES USING GORE® ACUSEAL VASCULAR GRAFTS TO TREAT RENAL DISEASE. PATIENT DEMOGRAPHICS SHOWS THAT THERE WERE 20 MALES AND 12 FEMALES WITH THE AVERAGE AGE OF 66.3 YEARS OLD. 25 PATIENTS WERE IMPLANTED WITH THE GORE® ACUSEAL VASCULAR GRAFT IN THEIR FOREARMS, 7 PATIENTS WERE IN THEIR UPPER ARMS, AND LOOP SHUNT WAS CREATED AMONG 24 PATIENTS WHILE STRAIGHT-SHAPED SHUNT WAS AMONG 8 PATIENTS. TREATMENT RESULTS SHOW 2 PATIENTS SUFFERED FROM GRAFT INFECTION DUE TO DIALYSIS PUNCTURE IN CASE #1, CASE #2, INFECTION WAS DUE TO DEHISCENCE AT THE GRAFT ANASTOMOSIS SITE. IN CASE #1, THE GORE® ACUSEAL VASCULAR GRAFT WAS TOTALLY REPLACED WITH ANOTHER VASCULAR GRAFT WHILE IN CASE #2, THE GORE® ACUSEAL VASCULAR GRAFT WAS PARTIALLY REMOVED TO TREAT GRAFT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777763 GORE ACUSEAL VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention