BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 20504857 · Received October 22, 2024

    Report

    Report Number
    3007284313-2024-03531
    Event Type
    Injury
    Date Received
    October 22, 2024
    Date of Event
    March 26, 2024
    Report Date
    December 17, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED H6: UPDATED COMPONENT CODE TO G04122 AND G07001. CODE G07003 WAS INADVERTENTLY ENTERED AND SHOULD BE REMOVED.

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. A2: MEAN AGE OF 72.1 YEARS WAS STATED IN THE ARTICLE. A3: PREDOMINANTLY MALE PATIENTS WAS STATED IN THE ARTICLE. B3: THE EXACT DATE OF EVENT IS UNKNOWN, THEREFORE, THE DATE OF WHICH THE EXPLANT TOOK PLACE WAS USED AS DATE OF EVENT. H3: OTHER CODE ¿ THE MEDICAL DEVICES ARE NOT RETURNED FOR INVESTIGATION; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. LITERATURE CITATION: SMORENBURG, S. P. M., DE BRUIN, J. L. ZEEBREGTS, C. J., REIJNEN, M. M. P. J., VERHAGEN, H. J. M., AND HEYLIGERS, J. M. M. (2024) ¿LONG TERM OUTCOMES OF THE GORE EXCLUDER LOW PERMEABILITY ENDOPROSTHESIS FOR THE TREATMENT OF INFRARENAL AORTIC ANEURYSMS,¿ EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, 68(1), PP. 18¿27. DOI: 10.1016/J.EJVS.2024.03.028 NO PATIENT SPECIFIC INFORMATION REGARDING THE REPORTED EVENTS AND INTERVENTIONS WAS PROVIDED IN THE ARTICLE. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED BECAUSE THE SERIAL/LOT NUMBER REMAINS UNKNOWN. GORE REACHED OUT MULTIPLE TIMES TO THE AUTHOR OF THE LITERATURE ARTICLE FOR DEVICE IDENTIFICATION LINKED WITH THE REPORTED OUTCOME. THE ANSWER IS NOT PROVIDED. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO ANEURYSM ENLARGEMENT, ENDOLEAK, ANEURYSM RUPTURE AND DEATH, OCCLUSION OF DEVICE OR NATIVE VESSEL, COMPONENT MIGRATION, INFECTION, CONVERSION, AND IMPROPER COMPONENT PLACEMENT. 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 ARTICLE WAS REVIEWED: SMORENBURG, S. P. M., DE BRUIN, J. L. ZEEBREGTS, C. J., REIJNEN, M. M. P. J., VERHAGEN, H. J. M., AND HEYLIGERS, J. M. M. (2024) ¿LONG TERM OUTCOMES OF THE GORE EXCLUDER LOW PERMEABILITY ENDOPROSTHESIS FOR THE TREATMENT OF INFRARENAL AORTIC ANEURYSMS,¿ EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, 68(1), PP. 18¿27. DOI: 10.1016/J.EJVS.2024.03.028 THIS RETROSPECTIVE, MULTI-CENTER STUDY EVALUATED LONG-TERM OUTCOMES OF 514 PREDOMINANTLY MALE PATIENTS WITH A MEAN AGE OF 72.1 YEARS WHO WERE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR INFRARENAL ABDOMINAL AORTIC ANEURYSMS (AAA) BETWEEN JUNE 2004 AND JANUARY 2017. PRIMARY OUTCOMES WERE OVERALL SURVIVAL, FREEDOM FROM REINTERVENTIONS, AAA SAC DYNAMICS: GROWTH (> 5 MM), STABILIZATION, AND REGRESSION (< 5 MM). SECONDARY OUTCOMES WERE TECHNICAL SUCCESS (DEVICE DEPLOYMENT), PROCEDURAL PARAMETERS, AND REINTERVENTIONS. 195 PATIENTS WERE REPORTED AS BEING TREATED OUTSIDE INSTRUCTIONS FOR USE (IFU). TREATMENT OUTSIDE IFU SIGNIFICANTLY INCREASED REINTERVENTION RATES AND ONE YEAR SAC GROWTH WAS ASSOCIATED WITH STATISTICALLY SIGNIFICANTLY WORSE SURVIVAL. TECHNICAL SUCCESS WAS ACHIEVED IN 89.7% OF THE PATIENTS AND WAS NOT ACHIEVED (IN 53 PATIENTS) DUE TO INTRA-OPERATIVE TYPE 1A/1B ENDOLEAK (5.1%), INTRA-OPERATIVE TYPE 3 ENDOLEAK (0.2%), UNINTENTIONAL COVERAGE OF A HYPOGASTRIC ARTERY (1.6%), AND DEPLOYMENT NOT AT THE PLANNED LOCATION (3.3%). OVERALL, 95 PATIENTS UNDERWENT A REINTERVENTION, OF WHICH 21 WERE EARLY (< 30 DAYS), MOSTLY DUE TO GROIN BLEEDING LEADING TO SURGICAL REINTERVENTION. THE MAIN CAUSE FOR REINTERVENTION WAS ENDOLEAK (75 PATIENTS): 23 PATIENTS WERE TREATED FOR A TYPE 1A ENDOLEAK, 22 PATIENTS FOR A TYPE 1B ENDOLEAK, 27 PATIENTS FOR A TYPE 2 ENDOLEAK, TWO PATIENTS FOR A TYPE 3 ENDOLEAK, AND ONE PATIENT FOR A SUSPECTED TYPE 4 ENDOLEAK. COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED SAC GROWTH IN THE ABSENCE OF A TYPE 1, 2, OR 3 ENDOLEAK. OCCLUSION AND THROMBUS WERE THE CAUSES OF REINTERVENTION IN THE MAIN BODY FOR ONE PATIENT AND IN THE DEVICE LIMB IN FIVE PATIENTS. GRAFT INFECTION WAS THE CAUSE FOR ONE REINTERVENTION, MIGRATION WAS THE CAUSE FOR ONE REINTERVENTION. A TOTAL OF SEVEN PATIENTS RUPTURED: ONE WAS IDENTIFIED AS A TYPE 3 ENDOLEAK, ANOTHER WAS DUE TO A TYPE 1A ENDOLEAK, AND THE THIRD WAS CAUSED BY A TYPE 1B ENDOLEAK; THE REMAINING CAUSES FOR THE OTHER FOUR CASES REMAINED UNDETERMINED DUE TO NON-AVAILABILITY OF RELEVANT INFORMATION IN THE RETROSPECTIVE DOCUMENTATION. OF THE RUPTURED CASES, THREE UNDERWENT OPEN REPAIR, ONE PATIENT WITH A SECONDARY RUPTURE WAS TREATED WITH ILIAC LIMB EXTENSION DUE TO A TYPE 1B ENDOLEAK, AND THREE PATIENTS DIED (THESE THREE PATIENTS ARE REPORTED WITH MANUFACTURER'S REFERENCE NUMBER MPD CASE-(B)(4), MANUFACTURER REPORT NUMBER 3007284313-2024-03530). NINE PATIENTS UNDERWENT CONVERSION TO OPEN REPAIR AND FOUR OF THEM WERE TREATED EITHER DUE TO A RUPTURED OR SYMPTOMATIC NON-RUPTURED AAA IN AN EMERGENCY SETTING. TWENTY-FOUR PATIENTS WITH TYPE 1A ENDOLEAK OR LOSS OF PROXIMAL SEAL UNDERWENT A PROXIMAL CUFF EXTENSION, AND FIVE OF THEM WERE ADDITIONALLY TREATED WITH HELI-FX ENDOANCHORS. TWENTY-ONE PATIENTS UNDERWENT ILIAC LIMB EXTENSION DUE TO DISEASE PROGRESSION AND OR TYPE 1B ENDOLEAK. FIVE PATIENTS UNDERWENT RELINING OR REVISION OF THEIR EVAR, OF WHICH ONE WAS THE PATIENT WITH THE TYPE 4 ENDOLEAK. TWO PATIENTS WERE MANAGED WITH A PROXIMAL FENESTRATED CUFF AFTER TYPE 1A ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934633 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other