BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 16542366 · Received March 14, 2023

    Report

    Report Number
    3007284313-2023-02387
    Event Type
    Injury
    Date Received
    March 14, 2023
    Date of Event
    August 25, 2019
    Report Date
    March 14, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132622443
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL HISTORY INCLUDES BUT IS NOT LIMITED TO: AAA, ACUTE RESPIRATORY FAILURE WITH HYPOXIA,ANEMIA. HEIGHT 5¿9¿, WEIGHT: 292 LBS. PATIENT MEDICATIONS INCLUDE BUT ARE NOT LIMITED TO: LEVALBUTEROL, AFORMOTEROL TARTRATE, PROPOFOL, SUCRALFATE, ASPIRIN. THE INSTRUCTIONS FOR USE (IFU) FOR THE GORE® EXCLUDER® AAA ENDOPROSTHESIS STATES, ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO: ENDOLEAK, ANEURYSM ENLARGEMENT/RUPTURE, SURGICAL CONVERSION. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON OR ABOUT (B)(6) 2019, THE FOLLOW-UP COMPUTED TOMOGRAPHY FOR THE PATIENT DETERMINED A TYPE II ENDOLEAK. THE PHYSICIAN REPORTED THAT THE PATIENT WAS LOST TO FOLLOW UP AFTER THIS APPOINTMENT. ON (B)(6) 2023, THE PATIENT PRESENTED EMERGENTLY TO THE EMERGENCY ROOM WITH A RUPTURED ANEURYSM AND A PROXIMAL TYPE I ENDOLEAK. THE PATIENT UNDERWENT CONVERSION TO OPEN AND THE PROXIMAL PORTION OF THE TRUNK WAS EXPLANTED AND REPLACED WITH A VASCULAR GRAFT WHICH WAS SEWN INTO THE ILIAC LIMBS WHICH WERE LEFT IN PLACE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN BELIEVES THE TYPE II ENDOLEAK SEEN AT THE INITIAL FOLLOW UP COUPLED WITH THE PROXIMAL TYPE I ENDOLEAK WERE THE CAUSE OF THE RUPTURE. THE AMOUNT OF ANEURYSM ENLARGEMENT WAS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913884 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. RLT261412 00733132622443

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other| H| R