BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 15429513 · Received September 15, 2022

    Report

    Report Number
    3007284313-2022-02114
    Event Type
    Injury
    Date Received
    September 15, 2022
    Date of Event
    August 17, 2022
    Report Date
    November 1, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132651078
    PMA / PMN Number
    P200030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. MEDICAL DEVICE PROBLEM CODE APPLIED IS A010767, PROBLEM ASSOCIATED WITH THE DEVICE BEING POSITIONED IN A LOCATION OTHER THAN INTENDED SHOULD ALSO BE INCLUDED BUT IS NOT CURRENTLY POPULATING. 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. H6. D15, CAUSE NOT ESTABLISHED. AN ENGINEERING EVALUATION WAS PERFORMED WITH CONSIDERATION TO ALL AVAILABLE INFORMATION. THE FOLLOWING OBSERVATIONS WERE MADE BY ENGINEERING: 1) THE ABILITY OF THE DEVICE TO CONSTRAIN/UNCONSTRAIN (OR ANY OTHER OUTCOMES THAT OCCUR DURING CONSTRAINING/UNCONSTRAINING) CANNOT BE ASSESSED VIA THE TWO PROVIDED IMAGES ALONE AS THIS FUNCTIONALITY IS AN INTERACTION BETWEEN THE ENDOPROSTHESIS, CONSTRAINING MECHANISM (SCREW ASSEMBLY), CONSTRAINING LOOP SUB-ASSEMBLY, AND LOCK MANDREL. SINCE THE ENDOPROSTHESIS AND DELIVERY SYSTEM WERE NOT RETURNED, THIS INTERACTION COULD NOT BE EVALUATED. 2) PER THE IMAGING EVALUATION, ONE OF THE PROXIMAL RADIOPAQUE MARKERS IS LOWER THAN THE OTHER TWO RADIOPAQUE MARKERS. IN ADDITION, THE STENT PATTERN SHOWS OVERLAP OF STENT ROWS AT THE PROXIMAL END OF THE DEVICE WITHIN THE VICINITY OF THE LOWER RADIOPAQUE MARKER. HOWEVER, THE ENGINEERING EVALUATION OF THE TWO PROVIDED IMAGES DID NOT YIELD ANY ADDITIONAL INFORMATION REGARDING THIS EVENT DESCRIPTION. BASED ON THE FINDINGS FROM THE EVALUATION, THE EVENT DESCRIPTION THAT ¿WHEN THE PHYSICIAN CONSTRAINED THE ENDOPROSTHESIS TO REPOSITION IT THE DEVICE WAS PULLED BACK AND THE RE-CONSTRAINING KNOB WAS ALL OF THE WAY DOWN¿ COULD NOT BE CONFIRMED, BUT THE EVENT DESCRIPTION THAT ¿AS REPORTED, IT WAS OBSERVED THAT ¿ ON THE OTHER SIDE OF THE PATIENT THE ENDOPROSTHESIS APPEARED TO BE CAUGHT ON ITSELF AND BUNCHING UP LIKE AN ACCORDION¿ CAN BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION AND NO MANUFACTURING DEFICIENCIES WERE IDENTIFIED DURING THE INVESTIGATION. AS A RESULT, A CAPA REQUEST IS NOT REQUIRED PER MD145952. CORRECTION B1 UPDATED TO INCLUDE ADVERSE EVENT (AE) AND PRODUCT MALFUNCTION. THE AE IS RELATED TO THE PARTIAL RENAL COVERAGE AND THE MALFUNCTION WAS APPLIED FOR THE STENT BUNCHING. G2 REPORT SOURCE ¿ COMPANY REPRESENTATIVE BOX WAS CHECKED. PRECIOUSLY OTHER WAS CHECKED AND THIS WAS TYPED INTO THE DESCRIPTIVE TEXT FIELD. G3 / G4 DATE RECEIVED BY MANUFACTURER UPDATED TO 27-OCT-2022, AS EVALUATION ACTIVITIES WERE COMPLETE IN FULL ON THIS DATE. H1 / H2 TYPE OF REPORTABLE EVENT UPDATED TO SERIOUS INJURY AS THIS EVENT WAS BOTH A SERIOUS INJURY AND A MALFUNCTION. ALSO, BOTH CORRECTION AND ADDITIONAL INFORMATION WERE INDICATED. H6. E2403, NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, WAS REPLACED WITH E2328 AS THERE WAS PARTIAL OCCLUSION OF THE RENAL WHICH REQUIRED ADDITIONAL DEVICE. H6. C21, RESULTS PENDING COMPLETION OF INVESTIGATION WAS REPLACED WITH THE FINDINGS. D16. CONCLUSION NOT YET AVAILABLE WAS REPLACED WITH THE FINAL INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    INFORMATION ON PATIENT MEDICATIONS WAS REQUESTED BUT WAS NOT MADE AVAILABLE. COMORBIDITIES: HYPERTENSION / COPD. 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 AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". 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) 2022, THE PATIENT WAS ADMITTED FOR TREATMENT OF AN ABDOMINAL AND AN ILIAC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. AS REPORTED, THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WAS LANDED SLIGHTLY HIGH WITH THE TOP OF THE GRAFT PARTIALLY INTO THE LEFT RENAL ARTERY. REPORTEDLY THE DEVICE WAS RE-CONSTRAINED SO THAT IT COULD BE BETTER POSITIONED AND PULLED DOWN LOWER. AS REPORTED, WHEN THE PHYSICIAN CONSTRAINED THE ENDOPROSTHESIS TO REPOSITION IT THE DEVICE WAS PULLED BACK AND THE RE-CONSTRAINING KNOB WAS ALL OF THE WAY DOWN. AS REPORTED, IT WAS OBSERVED THAT ON ONE SIDE OF THE ENDOPROSTHESIS THE PROXIMAL ANCHORS APPEARED TO BE HOOKED INTO THE RENAL ARTERIES AND ON THE OTHER SIDE OF THE PATIENT THE ENDOPROSTHESIS APPEARED TO BE CAUGHT ON ITSELF AND BUNCHING UP LIKE AN ACCORDION. IMAGES ARE AVAILABLE FOR CONSIDERATION. AS REPORTED, THEY DEMONSTRATE THAT ONE OF THE RADIOPAQUE MARKERS ON THE PROXIMAL END OF THE DEVICE IS SIGNIFICANTLY LOWER THAN THE OTHER. AS REPORTED THE PHYSICIAN CHOSE TO PLACE A STENT TO PROTECT THE RENAL ARTERY AND PLACED A CUFF BELOW THE TOP OF THE IPSILATERAL ENDOPROSTHESIS. AS REPORTED, THE PATIENT TOLERATED THE PROCEDURE. A REVIEW OF MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS. THE IMAGING EVALUATION SHOWED THE FOLLOWING: THE IMAGES RECEIVED CANNOT BE USED TO PERFORM A FULL IMAGING EVALUATION. THE EXTENT AND ACCURACY OF THE OBSERVATIONS AND FINDINGS MAY BE LIMITED DUE TO THE COMPLETENESS, FORMAT AND/OR QUALITY OF THE AVAILABLE IMAGES PROVIDED FOR REVIEW. GORE CANNOT GUARANTEE THE IMAGES PROVIDED ARE ACCURATE OR LACK ALTERATION. THEREFORE, GORE CANNOT GUARANTEE ALL KEY FINDINGS HAVE BEEN CAPTURED OR THAT THE FINDINGS ARE ACCURATE. TWO STILL IMAGES PROVIDED FOR EVALUATION. NO NAME, DATE, OR DEMOGRAPHICS ON THE IMAGES. IMAGE #1 SHOWS: 1) ONE OF THE PROXIMAL DEVICE MARKERS IS LOWER THAT THE OTHER 2 PROXIMAL DEVICE MARKERS ON THE IMAGE PROJECTION PROVIDED. 2) THE STENT PATTERN SHOWS OVERLAP OF STENT ROWS IN THE PROXIMAL DEVICE TOWARD THE LOW MARKER. 3) NO ENDOLEAK OBSERVED ON AVAILABLE IMAGES. IMAGE #2 SHOWS: 1) A STENT IS OBSERVED IN THE LEFT RENAL ARTERY AND THE ARTERY IS PATENT ON THE IMAGE PROVIDED. 2) THE LOW MARKER APPEARS TO BE ON THE IPSILATERAL SIDE OF THE DEVICE. 3) AN ADDITIONAL DEVICE IS WITHIN THE PROXIMAL END OF THE ORIGINAL DEVICE IMPLANTED, CONFIRMED BY THE INCREASE IN RADIOPAQUE MARKERS PRESENT IN THE AORTA. ENGINEERING EVALUATION OF THE AVAILABLE INFORMATION IS STILL IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2521453 GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. CXT361414 00733132651078

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other