BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS

    MDR report key: 11809174 · Received May 11, 2021

    Report

    Report Number
    2017233-2021-01976
    Event Type
    Death
    Date Received
    May 11, 2021
    Date of Event
    December 7, 2018
    Report Date
    April 26, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED B2: DEATH. ADDED G3/G4 AND PMA/510K NUMBER. ADDED H1/H2. ADDED H6: COMPONENT CODE.

    Additional Manufacturer Narrative · 1

    A LIST OF BASELINE CHARACTERISTICS FOR THE COMPLICATIONS GROUP HAS BEEN PROVIDED IN THE ARTICLE. NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. THE MEAN AGE OF THE COMPLICATION GROUP WAS STATED TO BE 70.4 YEARS. IT WAS STATED THAT 15 SUBJECTS WERE MALE. THE DATE OF INCIDENT IS UNKNOWN. THEREFORE, THE DATE THE ARTICLE WAS PUBLISHED ONLINE WAS USED. THE AUTHOR HAS BEEN CONTACTED MULTIPLE TIMES TO PROVIDE ADDITIONAL INFORMATION REGARDING THE REPORTED ADVERSE EVENTS. NO INFORMATION HAS BEEN PROVIDED TO DATE. LOT/SERIAL NUMBERS WERE NOT PROVIDED, THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED.

    Description of Event or Problem · 1

    THE FOLLOWING PUBLICATION WAS REVIEWED: ¿ASSESSMENT OF GEOMETRICAL REMODELLING OF THE AORTIC ARCH AFTER HYBRID TREATMENT¿ (GIOVANNI SPINELLA, ET. AL, EUR J CARDIOTHORAC SURG, 2019, PUBLISHED ONLINE 7 DECEMBER 2018). THE AIM OF THIS STUDY WAS TO MEASURE THE MORPHOLOGICAL REMODELLING OF THE ASCENDING AORTA, AORTIC ARCH AND THORACIC AORTA AFTER AORTIC ARCH HYBRID TREATMENT INCLUDING DEBRANCHING AND STENT GRAFT IMPLANTATION. A SINGLE-CENTRE, RETROSPECTIVE STUDY WAS CONDUCTED ON ALL CON­SECUTIVE PATIENTS WHO UNDERWENT AORTIC ARCH HYBRID TREATMENT BETWEEN JANUARY 2012 AND DECEMBER 2016. A TOTAL OF 22 PATIENTS TREATED IN ZONES 0, 1 OR 2 ACCORDING TO THE LSHIMARU CLASSIFICATION WERE INCLUDED IN THE STUDY. NINE PATIENTS PRESENTED WITH THORACIC AORTIC ANEURYSMS, 9 HAD PENETRATING AORTIC ULCER COMPLICATED BY A PSEUDOANEURYSM AND 4 HAD AN AORTIC INTRAMURAL HAEMATOMA. ALTOGETHER, 41 ENDOGRAFTS CORRESPONDING TO 3 DIFFERENT TYPES OF DEVICES WERE DEPLOYED FOR 22 PROCEDURES: 10 PATIENTS RECEIVED THE LOW-PROFILE ZENITH ALPHA ENDOGRAFT (COOK, BLOOMINGTON, IN, USA), 7 RECEIVED THE RELAY NBS ENDOGRAFT (BOLTON, BARCELONA, SPAIN) AND 5 THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. TECHNICAL SUCCESS WAS ACHIEVED IN 100% OF CASES. THE FOLLOWING COMPLICATIONS WERE OBSERVED DURING FOLLOW-UP: 1 CASE OF ASYMPTOMATIC RETROGRADE TYPE A AORTIC DISSECTION (RTAAD) REVEALED BY 1-MONTH CTA WHICH REQUIRED REINTERVENTION. IT WAS STATED THAT THE PATIENT DIED FROM SEPSIS AFTER OPEN REPAIR. 1 CASE OF AORTIC DISSECTION ON THE DISTAL LANDING ZONE AT 3-MONTH FOLLOW-UP RESOLVED BY OPEN REPAIR. 1 CASE OF PSEUDOANEURYSM WITH AORTIC RUPTURE ON THE DISTAL LANDING ZONE AT 1 YEAR OF FOLLOW-UP WITH REQUIRED ENDOVASCULAR REINTERVENTION. 1 CASE OF TYPE 1B ENDOLEAK AT 1-MONTH FOLLOW-UP. IT WAS NOT INDICATED IF THE REPORTED ADVERSE EVENTS ARE RELATED TO THE IMPLANTED CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700518 CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Death