BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

    MDR report key: 17939234 · Received October 16, 2023

    Report

    Report Number
    3013164176-2023-01870
    Event Type
    Death
    Date Received
    October 16, 2023
    Date of Event
    September 19, 2023
    Report Date
    October 23, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132635290
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE B20 -THE DEVICE REMAINS IMPLANTED AND WAS THEREFORE NOT AVAILABLE FOR ENGINEERING EVALUATION BY GORE. 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.

    Additional Manufacturer Narrative · 0

    H6: CODE C19 - A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO VASCULAR SPASM OR VASCULAR TRAUMA (BLEEDING, RUPTURE, DEATH) AND REOPERATION.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR ZONE 9 INFRARENAL PROCEDURE TO TREAT AN AORTIC ANEURYSM UTILIZING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. REPORTEDLY, THE GORE DEVICE WAS PUT IN FOR AN OCCLUSIVE DISEASE AND PATIENT HAD A VERY CALCIFIED DISEASED AORTA. AFTER THE INITIAL PROCEDURE ON THE ICU FLOOR, THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE. THERE WAS A CTA DONE THAT SHOWED POSSIBLE EXTRAVASATION. THE PATIENT WAS BROUGHT BACK TO THE OR FOR AN ANGIOGRAM THAT DID NOT SHOW ANYTHING AND THE PATIENT STABILIZED. THE PATIENT AGAIN EXPERIENCED PRESSURE DROPS AND THE PATIENT WAS SURGICALLY OPENED. UPON SURGERY, IT WAS FOUND THAT THE DEVICE WAS VISIBLE THROUGH THE AORTA. THE PATIENT ENDED UP EXPIRING ON THE SURGICAL TABLE. THE PHYSICIAN BELIEVES THERE WAS AN AORTA RUPTURE WHEN BALLOONING THE DEVICE AND ARE STILL UNSURE WHY BLOOD WAS STILL LEAKING INTO THE PERICARDIAL SPACE. THE PHYSICIAN DOESN'T BELIEVE THE DEVICE WAS CAUSE FOR THE DEATH AND THE DEVICE IS VISIBLE THROUGH THE RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2116823 GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132635290

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Death