BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS

    MDR report key: 10342805 · Received July 30, 2020

    Report

    Report Number
    2017233-2020-01066
    Event Type
    Death
    Date Received
    July 30, 2020
    Date of Event
    February 22, 2019
    Report Date
    August 19, 2020
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENTS DIAGNOSED WITH A PRE-EXISTING RUPTURE OF THE ABDOMINAL AORTA ARTERY, AND WHOSE DEATH IS ATTRIBUTED TO THE PRE-EXISTING RUPTURE. THEREFORE, THIS EVENT WAS DETERMINED TO BE NON-REPORTABLE DUE TO THE PRE-EXISTING RUPTURE MENTIONED IN THE ARTICLE WAS NOT RELATED TO GORE DEVICE. THIS MEDWATCH WILL BE VOIDED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS DEVICE LOT NUMBERS WERE NOT AVAILABLE. THE IMAGES AND DEVICE WERE NOT AVAILABLE, THE IMAGING EVALUATION AND ENGINEERING EVALUATION COULD NOT BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING PUBLICATION WAS REVIEWED: " ENDOVASCULAR AORTIC REPAIR IS A VIABLE STRATEGY FOR TREATMENT OF PRIMARY INFECTED ABDOMINAL AORTIC ANEURYSM¿ RECEIVED THROUGH ANN VASC SURG 2020; 63: 117¿128. THE AUTHORS: XIAO DI, CHANGWEI LIU, RONG ZENG, AND LENG NI. THE ARTICLE AIMED THAT INFECTED ABDOMINAL AORTIC ANEURYSM (IAAA) IS RARE, AND INFORMATION IS LIMITED WHETHER ENDOVASCULAR AORTIC REPAIR (EVAR) CAN BE CONSIDERED A PERMANENT TREATMENT OR IS A TEMPORARY FIX PRECEDING OPEN SURGERY. THIS RETROSPECTIVE STUDY REVIEWED THE SHORT- AND LONGTERM OUTCOMES OF OPEN SURGERY, EMERGENT EVAR, AND ELECTIVE EVAR IN THE TREATMENT OF PRIMARY IAAA. THE STUDY POPULATION COMPRISED 19 PATIENTS TREATED FOR IAAA AT PEKING UNION MEDICAL COLLEGE HOSPITAL BETWEEN JANUARY 2008 AND JANUARY 2017. REPORTED RESULTS STATED THERE WAS ONE DEATH (5.26%) AMONG THE 19 PATIENTS WITHIN THE FIRST POSTOPERATIVE 30 DAYS. THAT PATIENT (PATIENT 4) HAD A SUDDEN RUPTURE OF THE ABDOMINAL AORTA (IMPLANTED WITH GORE EXCLUDER 28-150) DURING PREOPERATIVE ANTIMICROBIAL TREATMENT AND DID NOT SURVIVE AFTER THE EMERGENT EVAR PROCEDURE(POST-OP SURVIVAL: 1 DAY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811492 CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death