MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	CXA230005
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	12/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, this patient underwent an endovascular treatment for inflammatory abdominal aortic aneurysm using gore® excluder® conformable aaa endoprosthesis with active control system and gore® excluder® aaa endoprosthesis.The patient¿s aortic neck was a very complex anatomy, making it difficult to predict how the devices would be implanted; therefore, the snorkel technique was prepared for both the renal arteries before implanting the proximal devices.The renal arteries were intentionally partial-covered and bare-metal stents (express vascular sd) were additionally implanted in the renal arteries.Eventually, 6 stent grafts (cxt231412, pll161407j, plc161000j, plc141000j, cxa230005, plc121000j) were implanted.The final angiography showed only a type ii endoleak from the inferior mesenteric artery (ima).No other endoleak was found, so the procedure was concluded.The patient tolerated the procedure.On (b)(6) 2024, a follow-up enhanced ct scan showed a type ia endoleak, type ii endoleak from the ima and rapid aneurysm enlargement (size unknown).On the same day, a semi-emergency open conversion was performed.During the open repair, the excluder legs were cut and the proximal portion was explanted.The remaining distal portions were anastomosed with the y-shaped graft.The plc121000j which was placed most distally in the right side was intact and not explanted.During anastomosis, a type ib endoleak occurred from the left side for some reason.The left internal iliac artery was embolized and two additional components (plc141400j, pll161007j) were implanted to extend the treatment area into the external iliac artery.The patient¿s condition has since stabilized and he is scheduled to be discharged on (b)(6) 2024.The reporting physician commented as follows: the patient¿s condition had been not suitable for endovascular treatment at the initial procedure.Considering the patient¿s advanced age and medical history, stent graft treatment was chosen; however, possibly open repair should have been performed in the first place.Although the type ii and type ia endoleaks are possible causes of the rapid enlargement, it is possibly more plausible that the cause is the progression of inflammation, since it does not usually enlarge this quickly.
Additional Manufacturer Narrative
H3: code "other" was selected as the medical device was discarded at facility.Return not possible.H6: code b14: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: code b15: the images received cannot be used to perform a full imaging evaluation because they do not meet the dicom standard.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the images provided for review.Gore cannot guarantee the images provided are complete, accurate or lack alteration.Therefore, gore cannot guarantee all key findings have been captured or that the findings are accurate.The imaging evaluation performed by a clinical imaging specialist showed the following: the jpgs were submitted for evaluation.Unable to confirm the presence of a type i endoleak or a type ii endoleak with the available image set.H6: code d12: according to the gore® excluder® conformable aaa endoprosthesis instructions for use, adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: endoleak.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.

• Brand Name: GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: tatsuya sato ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18947621
• Report Number: 3007284313-2024-03121
• Device Sequence Number: 7078217
• Product Code: MIH
• UDI-Device Identifier: 00733132650934
• UDI-Public: 00733132650934
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2026
• Device Catalogue Number: CXA230005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male