BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 15840333 · Received November 21, 2022

    Report

    Report Number
    3013164176-2022-01547
    Event Type
    Injury
    Date Received
    November 21, 2022
    Date of Event
    October 23, 2022
    Report Date
    December 6, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618538
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICATIONS, COMORBIDITIES, AND WEIGHT WERE NOT PROVIDED BY THE TREATING FACILITY. AS GORE WAS UNABLE TO DETERMINE WHICH DEVICE(S) CAUSED OR CONTRIBUTED TO THE EVENT IF ANY; ADDITIONAL DEVICE(S) IMPLANTED RELATED TO THIS EVENT INCLUDE THE FOLLOWING: 11183-4: BRAND: GORE® EXCLUDER® AAA ENDOPROSTHESIS, PRODUCT NAME: STENT GRAFT ILIAC EXTENDER, CATALOG NUMBER: PLL161407, LOT/SN: (B)(4), UDI: (B)(4). 11183-5: BRAND: GORE® EXCLUDER® AAA ENDOPROSTHESIS, PRODUCT NAME: STENT GRAFT TRUNK IPSILATERAL LEG C3, CATALOG NUMBER: RLT281412, LOT/SN: (B)(4), UDI: (B)(4). 11183-6: BRAND: GORE® EXCLUDER® AAA ENDOPROSTHESIS, PRODUCT NAME: STENT GRAFT CONTRALATERAL LEG, CATALOG NUMBER: PLC271400, LOT/SN: (B)(4), UDI: (B)(4). COMMUNICATION/INTERVIEWS- ADDITIONAL INFORMATION IN REGARD TO THE EVENT OF THE CASE WAS REQUESTED. THE PROVIDED ADDITIONAL INFORMATION IS CAPTURED IN THE EVENT DESCRIPTION. RESULTS PENDING COMPLETION OF INVESTIGATION: MANUFACTURING EVALUATION RESULTS WILL BE PROVIDED ONCE THEY ARE COMPLETED. DEVICE NOT ACCESSIBLE FOR TESTING: AS REPORTED THE DEVICES ARE NOT ACCESSIBLE FOR TESTING. IT IS NOT CONFIRMED IF ALL IMPLANTED DEVICES WERE EXPLANTED OR JUST A PORTION OF THEM. THOSE THAT WERE EXPLANTED WERE NOT RETURNED FOR INVESTIGATION. 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, NO DEVICE PROBLEM FOUND: A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS. G3/G4. DATE RECEIVED BY MANUFACTURER UPDATED TO (B)(6) 2022, AS THE MANUFACTURING RECORD REVIEWS WERE COMPLETED ON THIS DATE. H6. G CODE UPDATED FROM G04122 STENT TO G07001 H6. CODE C21, RESULTS PENDING COMPLETION OF INVESTIGATION WAS REPLACED WITH FINDINGS H6. CODE D16, CONCLUSION NOT YET AVAILABLE REPLACED WITH CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    H6: G CODE UPDATED FROM G07001 TO G04122.

    Description of Event or Problem · 0

    ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND BILATERAL GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES FOR TREATMENT OF AN ANEURYSM. CASE PLANNING FROM (B)(6) 2019 WAS PROVIDED FOR CONSIDERATION. AS REPORTED, ON (B)(6) 2022, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A SPINE ABSCESS. COMPUTED TOMOGRAPHY (CT) WAS PERFORMED AND SHOWED PATENCY ON ALL COMPONENTS EXCEPT THE BRANCH OF THE LEFT INTERNAL ILIAC. AS REPORTED A SAMPLE OF THE ABSCESS WAS TAKEN. ON (B)(6) 2022, THE PATIENT PRESENTED WITH RETROPERITONEAL BLEED AND AIR IN THE ANEURYSM SAC. AS REPORTED, THE PHYSICIAN BELIEVED THERE TO BE A RUPTURE COMING FROM THE RIGHT LIMB BASED ON HOW THE RETROPERITONEAL BLEED PRESENTED WITHIN THE CT AND PROCEEDED WITH OPEN REPAIR. REPORTEDLY, UPON OPEN REPAIR, IT WAS OBSERVED THAT THE ANEURYSM SAC WAS FULL OF PUSS. AS REPORTED, THE RETROPERITONEAL BLEED WAS NOT DUE TO THE ANEURYSM RUPTURE, BUT THE SPINAL BIOPSY THAT HAD STUCK THE ANEURYSM SAC. AS REPORTED, THE BACK SIDE OF THE ANEURYSM SAC HAD ERODED INTO THE BOWEL. AS REPORTED, THE GRAFT WAS EXPLANTED. AS REPORTED, THE PATIENT TOLERATED THE PROCEDURE AND WAS DOING WELL AS OF (B)(6) 2022. CONFIRMATION OF DEVICE SERIAL NUMBERS THAT WERE IMPLANTED IN THE PATIENT WERE REQUESTED AND OBTAINED. HOWEVER IT WAS NOT CONFIRMED WHICH ENDOPROSTHESES OR IF ALL OF THE IMPLANTED ENDOPROSTHESES WERE EXPLANTED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898074 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. PLC271000 00733132618538

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Life Threatening| R SEE H10/H11