BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 15499409 · Received September 28, 2022

    Report

    Report Number
    3007284313-2022-02131
    Event Type
    Injury
    Date Received
    September 28, 2022
    Date of Event
    January 1, 2021
    Report Date
    December 16, 2022
    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

    TITLE: A CASE OF ADDITIONAL OPEN SURGERY FOR ABDOMINAL AORTIC ANEURYSM WITH PROXIMAL STENT MIGRATION AFTER STENT GRAFT INSERTION. SOURCE: MEDICAL JOURNAL OF SAISEIKAI SHIGA HOSPITAL 2021: 30() P.33-37. (B)(4). ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), POTENTIAL ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK, ANEURYSM ENLARGEMENT, AND COMPONENT MIGRATION. 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 FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    H6: ADDED CODE D12: KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    THE FOLLOWING PUBLISHMENT WAS REVIEWED BY GORE: TITLE: A CASE OF ADDITIONAL OPEN SURGERY FOR ABDOMINAL AORTIC ANEURYSM WITH PROXIMAL STENT MIGRATION AFTER STENT GRAFT INSERTION. SOURCE: MEDICAL JOURNAL OF SAISEIKAI SHIGA HOSPITAL 2021: 30() P.33-37. THE PATIENT WAS A 78-YEAR-OLD MALE. EVAR USING EXCLUDER WAS PERFORMED FOR A RUPTURED RENAL ARTERY INFERIOR ABDOMINAL AORTIC ANEURYSM. THREE AND A HALF YEARS AFTER EVAR, THE PATIENT VISITED ANOTHER HOSPITAL WITH DIZZINESS, AND WAS TREATED WITH A DIAGNOSIS OF DEHYDRATION. ALTHOUGH THE SYMPTOM IMPROVED, A CT SCAN SHOWED DISTAL MIGRATION OF THE PROXIMAL STENT GRAFT AND ENLARGEMENT OF THE ANEURYSM TO 71 MM. RETREATMENT WAS NECESSARY TO PREVENT RUPTURE, BUT ENDOVASCULAR TREATMENT WAS DIFFICULT, IT WAS DETERMINED TO PERFORM OPEN SURGERY. SURGERY WAS PERFORMED THROUGH A MIDLINE ABDOMINAL INCISION AND A TRANSPERITONEAL APPROACH TO REACH THE ANEURYSM, AND THE LEFT RENAL VEIN WAS TRANSECTED. THE RENAL ARTERY SUPERIOR ABDOMINAL AORTA AND BILATERAL RENAL ARTERIES WERE CLAMPED, THE ANEURYSM WAS INCISED, AND THEN THE STENT GRAFT WAS CLAMPED TO CONTROL BLEEDING. THE BIFURCATED GRAFT WAS ANASTOMOSED END-TO-END TO PERFORM ARTIFICIAL VESSEL REPLACEMENT AT THE ABDOMINAL AORTA JUST BELOW THE RENAL ARTERIES ON PROXIMAL SIDE, AND AT THE LEGS OF THE BILATERAL STENT GRAFTS ON PERIPHERAL SIDE. POSTOPERATIVELY, THE PATIENT HAD A TEMPORARY WORSENING OF RENAL FUNCTION THAT IMPROVED TO NEAR PREOPERATIVE LEVELS UPON DISCHARGE. OPEN SURGERY AFTER EVAR HAS DIFFERENT DIFFICULTIES FROM CONVENTIONAL ARTIFICIAL BLOOD VESSEL REPLACEMENT. IN THIS CASE, THE FOLLOW-UP AFTER THE FIRST EVAR WAS INTERRUPTED, SO THE DETAILED COURSE IS UNKNOWN. HOWEVER, IT WAS CONSIDERED THAT TYPE IA EL MIGHT OCCURRED DUE TO MIGRATION OF THE STENT GRAFT, LEADING TO RE-ENLARGEMENT OF THE ANEURYSM. THE ADDITIONAL INFORMATION WAS PROVIDED FROM FSA ON SEPTEMBER 7,2022: ON MARCH 24, 2021, THE PATIENT EXPIRED OF SHOCK DUE TO AORTO-DUODENAL FISTULA. THE PHYSICIAN STATED THAT THE EVENT WAS NOT RELATED TO THE GORE DEVICE. PHYSICIAN¿S COMMENT: IT WAS THOUGHT THAT THE PROXIMAL NECK WAS BENT AND RELATIVELY SHORT, AND THE LANDING ON THE LESSER CURVATURE SIDE OF THE NECK WAS PARTICULARLY INSUFFICIENT, LED TO THE MIGRATION. ALTHOUGH IT WAS AN EMERGENCY CASE FOR THE PURPOSE OF LIFESAVING, IT WAS UNAVOIDABLE, BUT THE PROGNOSIS MIGHT HAVE BEEN DIFFERENT IF MEASURES WERE TAKEN AT AN EARLY STAGE THROUGH CONTINUED F/U. PATIENT¿S DEATH: (B)(4) WAS OPENED TO CAPTURE THE AORTO-DUODENAL FISTULA AND THE PATIENT¿S DEATH. THE PHYSICIAN STATED THAT THE EVENT WAS NOT RELATED TO THE GORE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746774 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Hospitalization| R