BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 17807260 · Received September 25, 2023

    Report

    Report Number
    3007284313-2023-02766
    Event Type
    Injury
    Date Received
    September 25, 2023
    Date of Event
    November 20, 2020
    Report Date
    June 7, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132609949
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET PRE-RELEASE SPECIFICATIONS. THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: THREE FULL DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) IMAGE SETS AVAILABLE FOR EVALUATION. NAMES ARE ANONYMIZED. DATES ARE TAKEN OFF ALL DICOM HEADERS. NO PROXIMAL TRUNK IPSILATERAL/LIMB MIGRATION BETWEEN ALL TIME-POINTS RECEIVED. ALL IMAGE SETS (3) SHOW LACK OF DISTAL END OF DISTAL DEVICE APPOSITION IN THE RIGHT COMMON ILIAC ARTERY (RCI). TWO SETS OF IMAGING SHOW LACK OF DISTAL END OF DISTAL DEVICE APPOSITION IN THE LEFT COMMON ILIAC ARTERY (LCI) (PXC141000). ONE SET OF DICOM IMAGES HAS AN ADDITIONAL DEVICE (CONTRALATERAL LEG WITH 2 RADIOPAQUE MARKERS) IMPLANTED AND THERE ARE EMBOLIZATION MATERIALS PRESENT AT THE LEVEL OF THE LEFT INTERNAL ILIAC ARTERY AS PER DESCRIPTION SUMMARY. THERE IS MINIMAL CHANGE IN THE MAXIMUM DIAMETERS OF THE LCI BETWEEN TIME POINTS. THEREBY, DECREASING THE PROBABILITY OF DISEASE PROGRESSION. THE LACK OF DISTAL DEVICE APPOSITION IS RESOLVED IN THE LCI. THE PXC201000 IS IMPLANTED ON THE PATIENT¿S RIGHT SIDE AS AN EXTENSION TO THE IPSILATERAL LIMB IN THE RCI. ALL IMAGE SETS AVAILABLE SHOW LACK OF DISTAL DEVICE APPOSITION (PXC201000) IN THE RCI. MAXIMUM DIAMETERS OF THE RCI ARE =25MM ON ALL TIME-POINTS. LITTLE CHANGE IN MAX RCI DIAMETERS IS NOTED. 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 GROWTH. CORRECTED PRODUCT INFORMATION

    Additional Manufacturer Narrative · 0

    CORRECTED MANUFACTURING SITE.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET PRE-RELEASE SPECIFICATIONS. THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: THREE FULL DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) IMAGE SETS AVAILABLE FOR EVALUATION. NAMES ARE ANONYMIZED. DATES ARE TAKEN OFF ALL DICOM HEADERS. NO PROXIMAL TRUNK IPSILATERAL/LIMB MIGRATION BETWEEN ALL TIME-POINTS RECEIVED. ALL IMAGE SETS (3) SHOW LACK OF DISTAL END OF DISTAL DEVICE APPOSITION IN THE RIGHT COMMON ILIAC ARTERY (RCI). TWO SETS OF IMAGING SHOW LACK OF DISTAL END OF DISTAL DEVICE APPOSITION IN THE LEFT COMMON ILIAC ARTERY (LCI) (PXC141000). ONE SET OF DICOM IMAGES HAS AN ADDITIONAL DEVICE (CONTRALATERAL LEG WITH 2 RADIOPAQUE MARKERS) IMPLANTED AND THERE ARE EMBOLIZATION MATERIALS PRESENT AT THE LEVEL OF THE LEFT INTERNAL ILIAC ARTERY AS PER DESCRIPTION SUMMARY. THERE IS MINIMAL CHANGE IN THE MAXIMUM DIAMETERS OF THE LCI BETWEEN TIME POINTS. THEREBY, DECREASING THE PROBABILITY OF DISEASE PROGRESSION. THE LACK OF DISTAL DEVICE APPOSITION IS RESOLVED IN THE LCI. THE PXC201000 IS IMPLANTED ON THE PATIENT¿S RIGHT SIDE AS AN EXTENSION TO THE IPSILATERAL LIMB IN THE RCI. ALL IMAGE SETS AVAILABLE SHOW LACK OF DISTAL DEVICE APPOSITION (PXC201000) IN THE RCI. MAXIMUM DIAMETERS OF THE RCI ARE =25MM ON ALL TIME-POINTS. LITTLE CHANGE IN MAX RCI DIAMETERS IS NOTED. THIS COMPLAINT WAS INITIATED BASED ON INFORMATION RECEIVED FROM THE FIELD. THE PRODUCT REMAINS IMPLANTED, AND WAS NOT RETURNED FOR EVALUATION. THEREFORE THE CAUSE OF THE MIGRATION LEADING TO ILIAC ARTERY DILATION COULD NOT BE INDEPENDENTLY CONFIRMED DURING THE INVESTIGATION. BASED ON THE INCIDENT DESCRIPTION AND THE SUBSEQUENT INVESTIGATION, NO FURTHER INFORMATION WAS PROVIDED TO GORE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT AND ASSIGN A ROOT CAUSE. 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 GROWTH.

    Additional Manufacturer Narrative · 0

    D10: RMT311415 EXCLUDER C3 31MMX14.5MMX15CM - SN (B)(6); PXC141000 EXCLUDER 14.5MMX10CM - SN (B)(6); PXC141000 EXCLUDER 14.5MMX10CM - SN (B)(6). H3: DEVICE REMAINS IMPLANTED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET PRE-RELEASE SPECIFICATIONS. THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN A RETROSPECTIVE AND PROSPECTIVE OBSERVATIONAL COHORT REGISTRY DESIGNED TO OBTAIN EARLY DATA ON THE USE OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS WITH C3 DELIVERY SYSTEM THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT). MEDIDATA RAVE® IS THE CLINICAL STUDY DATABASE (CSD), CAPTURING THE DATA THROUGH THE GRT 10-12 MODULE. THE ABOVE INFORMATION WAS OBTAINED FROM THE CSD. 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

    IT WAS REPORTED THAT ON (B)(6) 2012, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS WITH C3 DELIVERY SYSTEM. ON (B)(6) 2020, THE PATIENT PRESENTING WITH EXPANSION OF THE LEFT SIDED ILIAC ANEURYSM REPORTEDLY CAUSED BY MIGRATION OF THE TRUNK IPSILATERAL LEG. ON (B)(6) 2021, THE PATIENT WAS TREATED WITH COIL EMBOLIZATION OF LEFT ILIAC INTERNAL BRANCHES AND IMPLANTATION OF AN ADDITIONAL DEVICE IN THE LEFT ILIAC ARTERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2012, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2020, THE PATIENT PRESENTED WITH ANEURYSM GROWTH IN THE LEFT ILIAC ARTERY. ON (B)(6) 2021, THE PATIENT WAS TREATED WITH EXTENSION OF THE ALREADY-IMPLANTED ENDOPROSTHESIS WITH AN ADDITIONAL DEVICE AND COIL EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810252 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 9397630 00733132609949

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Other SEE H10.