BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 11373782 · Received February 24, 2021

    Report

    Report Number
    3007284313-2021-01265
    Event Type
    Death
    Date Received
    February 24, 2021
    Date of Event
    January 1, 2014
    Report Date
    April 21, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING ARTICLE WAS REVIEWED. "MORBIDITY AND MORTALITY FOLLOWING ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS IN THE ELDERLY" DANIEL SILVERBERG MD, AHMAD ABU RMEILEH MD, DANIEL RASKIN MD, URI RIMON MD AND MOSHE HALAK MD. ISR MED ASSOC J. 2020 JAN;22(1):17-21. PMID: 31927800. IN TOTAL FOUR REPORTS RELATED TO THE REVIEWED LITERATURE WERE SUBMITTED: MANUFACTURER REPORT NUMBER 3007284313-2021-01265. MANUFACTURER REPORT NUMBER 3007284313-2021-01264. MANUFACTURER REPORT NUMBER 3007284313-2021-01266. MANUFACTURER REPORT NUMBER 3007284313-2021-01267. A1: THE PATIENT ID WAS NOT PROVIDED. THEREFOR THE GORE COMPLAINT REFERENCE NUMBER WAS USED. A2: THE MEAN AGE OF THE STUDY COHORT WAS 84 YEARS. A3: THE VAST MAJORITY THE PATIENTS WERE MALE. B3: THE EXACT EVENT DATE REMAINS UNKNOWN, THEREFORE (B)(6) 2014 WAS SELECTED AS A BEST ESTIMATE. D6A: THE EXACT IMPLANT DATE REMAINS UNKNOWN, THEREFORE (B)(6) 2012 WAS SELECTED AS A BEST ESTIMATE. H6-CODE 2919: ENDOLEAK TYPE III. H6-CODE 4581 AND 2682: ENDOLEAK TYP IB. H6-CODE 4111: A REQUEST WAS EMAILED TO THE CORRESPONDING AUTHOR TO PROVIDE ADDITIONAL INFORMATION LIKE SERIAL NUMBER, PATIENT IDENTIFIER, DATE OF BIRTH, AGE, WEIGHT, GENDER, NAME, DATE OF IMPLANTS ONSET DATE OF THE EVENTS, DATE OF REINTERVENTION, DESCRIPTION OF RELATED PROCEDURES AND INTRA- AND POSTPROCEDURAL DICOM ANGIOGRAPHY IMAGING SERIES. H6-CODE 3221: THE REQUESTED INFORMATION WAS NOT PROVIDED. WITH NO ADDITIONAL INFORMATION PROVIDED, GORE IS UNABLE TO PERFORM FURTHER INVESTIGATIONS OF THE RELATED COMPLAINTS. H6-CODE 4117: THE DEVICE REMAINS IMPLANTED IN THE PATIENT. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. H6-CODE 4119: THE SERIAL NUMBER OF THE DEVICE REMAINS UNKNOWN. THEREFORE, A REVIEW OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED. 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 · 1

    THE FOLLOWING ARTICLE WAS REVIEWED "MORBIDITY AND MORTALITY FOLLOWING ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS IN THE ELDERLY" DANIEL SILVERBERG MD, AHMAD ABU RMEILEH MD, DANIEL RASKIN MD, URI RIMON MD AND MOSHE HALAK MD ISR MED ASSOC J. 2020 JAN;22(1):17-21 PMID: 31927800 . THIS RETROSPECTIVE STUDY INCLUDED 128 PATIENTS OLDER THAN 80 YEARS OF AGE WHO UNDERWENT ELECTIVE ENDOVASCULAR ANEURYSM REPAIR OF ABDOMINAL AORTIC ANEURYSMS BETWEEN 2007 AND 2017. MEAN AGE WAS 84 ± 3.4 (RANGE 80-96) YEARS, AND 110 PATIENTS (86%) WERE MALE. THE DEMOGRAPHICS, PERIOPERATIVE MORBIDITY AND MORTALITY, AND LONG-TERM RESULTS WERE REPORTED. A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS USED IN 12 PATIENTS. THE GORE DEVICE MIGHT HAVE CAUSED OR CONTRIBUTE TO THE FOLLOWING ADVERSE EVENT REPORTED IN THE LITERATURE: ONE PATIENT DIED FROM ANEURYSM RUPTURE. THIS PATIENT UNDERWENT EVAR IN 2012, REQUIRED RE-INTERVENTION 2 YEARS LATER DUE TO A TYPE 3 ENDOLEAK AND WAS RE-ADMITTED DUE TO A RUPTURED ANEURYSM, MOST PROBABLY DUE TO AN UNDETECTED TYPE 1B ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269176 GORE EXCLUDER AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| H| L| R