BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)

    MDR report key: 8596514 · Received May 9, 2019

    Report

    Report Number
    3007284313-2019-00138
    Event Type
    Injury
    Date Received
    May 9, 2019
    Date of Event
    October 15, 2018
    Report Date
    June 11, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED SOURCE TO STATE COMPANY REPRESENTATIVE AND LITERATURE.

    Description of Event or Problem · 0

    IN REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED. ANIMESH RATHORE, MD, PETER GLOVICZKI MD, GUSTAVO S. ODERICH MD, AND THOMAS C BOWER MD, ¿COLLAPSED BIFURCATED MODULAR INFRARENAL ENDOGRAFT¿. COPYRIGHT© 2018 BY THE SOCIETY FOR VASCULAR SURGERY. LISTED IN THE ARTICLE IS A TABLE THAT DESCRIBES THE FOLLOWING: ONE PATIENT HAD A GORE® EXCLUDER® AAA ENDOPROSTHESIS IMPLANTED AND FOUR YEARS AFTER IMPLANT THE PATIENT PRESENTED WITH BACK PAIN, LEFT LE ISCHEMIA AND A TYPE B AORTIC DISSECTION. THE TYPE B DISSECTION WAS REPAIRED WITH ANOTHER ENODGRAFT. THE PATIENT WAS ASYMPTOMATIC AT 6 MONTHS AND THE POTENTIAL CAUSE OF COLLAPSE WAS REPORTEDLY DUE TO THE ACUTE TYPE B AORTIC DISSECTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    LOT/SERIAL NUMBERS WERE NOT PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), PATIENTS SHOULD BE COUNSELED AS TO THE POSSIBILITY OF SUBSEQUENT REINTERVENTIONS INCLUDING CATHETER-BASED AND OPEN SURGICAL CONVERSION.

    Description of Event or Problem · 1

    IN REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED. ANIMESH RATHORE, MD, PETER GLOVICZKI MD, GUSTAVO S. ODERICH MD, AND THOMAS C BOWER MD, ¿COLLAPSED BIFURCATED MODULAR INFRARENAL ENDOGRAFT¿. COPYRIGHT© 2018 BY THE SOCIETY FOR VASCULAR SURGERY. LISTED IN THE ARTICLE IS A TABLE THAT DESCRIBES THE FOLLOWING: ONE PATIENT HAD A GORE® EXCLUDER® AAA ENDOPROSTHESIS IMPLANTED AND FOUR YEARS AFTER IMPLANT THE PATIENT PRESENTED WITH BACK PAIN, LEFT LE ISCHEMIA AND A TYPE B AORTIC DISSECTION. THE TYPE B DISSECTION WAS REPAIRED WITH ANOTHER ENDOGRAFT. THE PATIENT WAS ASYMPTOMATIC AT 6 MONTHS AND THE POTENTIAL CAUSE OF COLLAPSE WAS REPORTEDLY DUE TO THE ACUTE TYPE B AORTIC DISSECTION. PATIENT WAS ASYMPTOMATIC AT 6 MONTHS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389921 AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R