BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 18127722 · Received November 13, 2023

    Report

    Report Number
    3007284313-2023-02882
    Event Type
    Death
    Date Received
    November 13, 2023
    Date of Event
    December 27, 2019
    Report Date
    November 13, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE C19- A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE B20- THE DEVICE WAS NOT MADE AVAILABLE TO GORE AND WAS THEREFORE NOT AVAILABLE FOR ENGINEERING EVALUATION. H6: CODE B15- REVIEW OF THE LITERATURE ARTICLE. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATE, ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO NEUROLOGIC DAMAGE, LOCAL OR SYSTEMIC (E.G., STROKE, PARAPLEGIA, PARAPARESIS) AND DEATH. SINCE IT IS UNKNOWN WHICH DEVICE IS DIRECTLY IMPLICATED IN THIS COMPLAINT, (B)(4) / UDI-DI (B)(4) AND (B)(4) / UDI-DI (B)(4) WILL BE INCLUDED ON THIS REPORT. 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

    THE FOLLOWING LITERATURE WAS REVIEWED: SHINGO NAKAI, ET AL. SPINAL CORD ISCHEMIA FOLLOWING ENDOVASCULAR REPAIR OF INFRARENAL ABDOMINAL AORTIC ANEURYSM. ANNALS OF VASCULAR DISEASES VOL. 13, NO. 3; 2020; PP 335¿338. CASE 2: A 76-YEAR-OLD MAN WITH ABDOMINAL AORTIC ANEURYSM (AAA) PRESENTING WITH SEVERE ABDOMINAL PAIN WAS FOUND TO HAVE A 60 MM INFRARENAL AAA ON NON-CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT). A CONTRAST-ENHANCED CT CONDUCTED 4 YEARS AGO SHOWED AN EXTREMELY SHAGGY AORTA. THIS PATIENT WAS CONSIDERED UNSUITABLE FOR OPEN SURGERY BECAUSE OF HIS POOR GENERAL CONDITION, SEVERE RENAL DYSFUNCTION, AND SARCOPENIA. EMERGENCY ENDOVASCULAR AORTIC REPAIR (EVAR) WAS CONDUCTED TO PREVENT AAA RUPTURE. THE RIGHT INTERNAL ILIAC ARTERY WAS OCCLUDED BY USING EMBOLIZATION COILS SINCE THE LANDING LENGTH OF RIGHT COMMON ILIAC ARTERY (CIA) WAS SHORT (15 MM) WITH A HOSTILE NECK AND RAISED CONCERNS REGARDING A TYPE1B ENDOLEAK. THIS WAS FOLLOWED BY EVAR WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE DISTAL LANDING SITES WERE LEFT CIA AND RIGHT EXTERNAL ILIAC ARTERY WITH LIMB EXTENSION. THE PATIENT WAS DIAGNOSED WITH COMPLETE PARAPLEGIA SOON AFTER EVAR. ALTHOUGH SPINAL CORD INJURY (SCI) WAS INTENSIVELY MANAGED, INCLUDING CEREBROSPINAL FLUID DRAINAGE, STEROID INFUSIONS, AND NALOXONE, THE PATIENT DIED 9 DAYS FOLLOWING EVAR SECONDARY TO BOWEL NECROSIS. THE AUTHORS STATED AS FOLLOWS: THIS CASE WAS KNOWN TO HAVE A SHAGGY AORTA WITH SEVERE ATHEROSCLEROTIC CHANGES BASED ON IMAGING. THEREFORE, INTRAOPERATIVE EMBOLISM, WHICH DECREASED THE SPINAL CORD PERFUSION, WAS CONSIDERED AS PATHOGENESIS OF SCI. FREQUENT DEVICE INSERTION AND REMOVAL FROM THE SHAGGY AORTA MAY HAVE CONTRIBUTED TO SCI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1978302 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention| S| D