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

Catalog Number CXT361414

Device Problems Positioning Problem (3009); Migration (4003)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/27/2024

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2024, a patient underwent endovascular treatment of an abdominal aortic aneurysm and a right internal iliac artery aneurysm using gore® excluder® conformable aaa endoprosthesis.During the treatment, a proximal side of a trunk-ipsilateral leg stent graft was deployed with full angulation and very slow speed, then the proximal side of the stent graft at an inner curvature did not deployed appropriately and appeared to be infolding.The constraining mechanism was used to fix it, however it was not resolved.Touch-up was performed and it was slightly improved.A ballooning was performed from outside of the stent graft, however it was not resolved.A 20 fr gore® dryseal flex introducer sheath with the dilator was inserted from outside of the stent graft, however it was not resolved.Only the sheath tube was inserted from outside of the stent graft and the stent graft at the inner curvature was successfully pushed up.Additional touch-up was performed and the stent graft was deployed more appropriately.The proximal level of the stent graft was high.The stent graft was moved distally using the constraining mechanism, and a half and more of the renal artery was intentionally covered by the stent graft.At this time, the first stent row of the stent graft at the outer curvature was into the second stent row but the stent graft was fixed well at the inner curvature.The physician decided to continue the treatment because the proximal side of the stent graft could be fixed using additional stent graft.After leg devices were implanted, an angiography revealed a proximal type i endoleak.Additional stent graft, endurant, was implanted into the proximal side of the trunk-ipsilateral leg and the proximal type i endoleak was reduced but remained.Additionally a stent graft was implanted.An angiography revealed that the proximal type i endoleak was reduced but remained slightly.The physician assumed that the proximal type i endoleak would resolve after the treatment, and decided to monitor it.The patient tolerated the procedure.The physician stated that the deployment issue may have been due to too much angulation or because the stent graft was oversized for the diameter of the vessel just below the renal artery.

Manufacturer Narrative

A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.Type of investigation: code b20: device remains implanted and therefore not available for direct analysis.Investigation conclusions: code d12: according to the gore® excluder® conformable aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: endoprosthesis or delivery system: improper component placement; incomplete component deployment; unintentional / premature component deployment; leading end catheter component retention; component migration; separation of graft material from stent; occlusion; renal (e.G., artery occlusion, contrast toxicity, insufficiency, failure).H.6.: investigation conclusions: code d1103: according to the gore® excluder® conformable aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to, renal artery occlusion and improper component placement.Do not continue advancing any portion of the delivery system if resistance is felt during advancement of the guidewire, sheath, or catheter.Stop and assess the cause of resistance.Vessel or catheter damage or premature deployment have occurred and may result in potential patient harms.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
• Type of Device: 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: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19159340
• MDR Text Key: 340793688
• Report Number: 3007284313-2024-03186
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132651078
• UDI-Public: 00733132651078
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: CXT361414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/22/2024
• Date Device Manufactured: 11/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 79 YR
• Patient Sex: Male