BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 19563840 · Received June 18, 2024

    Report

    Report Number
    3013164176-2024-02108
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    May 23, 2024
    Report Date
    June 18, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618644
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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 MANUFACTURING SPECIFICATIONS. AS THE DEVICE WAS NOT ACCESSIBLE, THE PRODUCT HISTORY REVIEW (PHR) REVIEW WAS THE EXTEND OF THE INVESTIGATION. NO DEVICE PROBLEM WAS FOUND PER REVIEW OF THESE RECORDS. H6: CODE B20 ¿ THE DEVICE REMAINS IMPLANTED AND, THEREFORE, WAS NOT AVAILABLE FOR DIRECT ANALYSIS BY GORE. IMAGES WERE PROVIDED. IMAGING ANALYSIS REPORTED THE FOLLOWING: PRE-IMPLANT IMAGES SUBMITTED FOR EVALUATION. IMAGES ARE OF POOR CONTRAST OPACIFICATION AND THEREFORE SUBOPTIMAL FOR EVALUATION. RCI LENGTH MEASURES ~ 55.6 MM. RCI DIAMETERS RANGE FROM 7.8 MM ¿ 35.4 MM. LCI MEASURES ~ 40.3 MM. LCI DIAMETERS RANGE FROM 7.4 MM ¿ 8.8 MM. UNABLE TO CONFIRM DEVICE THROMBUS OR DEVICE COMPRESSION WITH PRE-IMPLANT IMAGES. H6: CODE D15-THERE IS INSUFFICIENT INFORMATION AVAILABLE FOR GORE TO REASONABLY DRAW CONCLUSIONS RELATED TO ASPECTS OF THE EVENT, THEREFORE CONCLUSION CODE ¿D15: CAUSE NOT ESTABLISHED¿ IS BEING USED. INSUFFICIENT INFORMATION MAY INCLUDE LIMITED OR MISSING RELEVANT MEDICAL RECORDS, INVOLVEMENT OF MULTIPLE IMPLANTED DEVICES (INCLUDING NON-GORE DEVICES) IN THE FIELD OF TREATMENT, PATIENT NON-COMPLIANCE, AND/OR A GENERAL LACK OF AVAILABLE DETAIL OR SPECIFICITY RELATED TO AN ADVERSE EVENT AND/OR DEVICE. 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

    ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A ZONE-9 INFRARENAL ANEURYSM, UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG COMPONENTS-PLC141200 ON THE LEFT AND PLC121400 ON THE RIGHT). ON (B)(6) 2024 DURING A FOLLOW-UP IMAGING, PLC141200 DEVICE APPEARED TO BE THROMBOSED. PHYSICIAN ALSO REPORTED THE LIMB WAS CRUSHED. IT WAS ALSO REPORTED THAT THE PHYSICIAN MENTIONED THERE WAS STENOSIS AT THE EDGE OF THE PLC121400 DEVICE (IMPLANTED ON THE RIGHT SIDE), AND THE DEVICE REMAINED PATENT. ON (B)(6) 2024. PATIENT UNDERWENT A REINTERVENTION SURGERY. PHYSICIAN PERFORMED A FEM BYPASS TO TREAT THE THROMBOSIS AND TREATED THE STENOSIS BY EXTENDING THE RIGHT SIDE WITH ANOTHER LIMB. PATIENT TOLERATED THE PROCEDURE. THE CAUSE OF REPORTED THROMBOSIS AND COMPRESSION IS UNKNOWN. FSA WAS NOT AT THE PROCEDURE. AND NO FURTHER INFORMATION IS AVAILABLE. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703137 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618644

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention