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 Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Migration (4003)

Event Date 12/06/2023

Event Type  Injury  

Event Description

On (b)(6) 2021, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® conformable aaa endoprostheses.It was noted that the procedure was off-label in nature due to the patient's anatomy, but that the patient was not a candidate for open procedure.It was reported that the patient had approximately 30-degrees of angulation in the aortic neck, tortuosity through the iliac arteries, calcification present in the proximal landing zone, and no infrarenal seal length.The conformable trunk-ipsilateral leg component was intentionally landed high due to the lack of proximal seal zone.The patient's renal artery was intentionally covered.A gore® viabahn® vbx balloon expandable endoprosthesis was used in a snorkel technique to maintain flow to the renal artery, and two contralateral leg components were implanted distally.It was noted that the trunk-ipsilateral leg component had proximal seal at the close of the procedure.On (b)(6) 2024, the gore representative became aware that the gore® excluder® conformable aaa system had been explanted non-emergently.Reportedly, on (b)(6) 2023, it was observed that the trunk-ipsilateral leg component had migrated distally approximately 2cm down into the aneurysm sac.It was further observed that a number of proximal device anchors had disconnected from the trunk and remained in the patient's aortic wall.It is unknown how many anchors were lodged in the patient's aortic wall, and how or why the anchors became disconnected from the device.A type i endoleak was present, but no aneurysm enlargement was observed.It was reported that the cause of the distal device migration was aortic neck growth.There were no reported issues with the contralateral limbs.It was reported that the patient was converted to open procedure and all implanted devices were explanted.The anchors were also removed from the aortic wall.A bi-femoral bypass was performed and the reintervention was completed.The explanted devices were discarded.The patient tolerated the reintervention.

Manufacturer Narrative

Additional devices included on this report are as follows: catalog #plc141400/ serial # (b)(6) / udi # (b)(4).Catalog #plc141000/ serial # (b)(6)/ udi # (b)(4).A.4.Patient weight: asked but unavailable b.7.Other relevant history, including preexisting medical conditions: asked but unavailable d.10.Concomitant medical products and therapy dates: asked but unavailable h.6.Type of investigation: code b15 - images were provided, and an imaging evaluation will be performed.Additionally, as the explanted device was discarded at the facility, an analysis of relevant data will be performed in view of supporting the identification of possible causes of the event.H.6.Investigation findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.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.

Manufacturer Narrative

H.6.Investigation findings for imaging evaluation: the evaluation noted - the images received were unable to 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 make conclusions or 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.The evaluation further stated: unable to confirm a type i endoleak, aortic dilation, and/or that the device moved >10 mm with the images received for evaluation.The position of the device is not immediately distal to the lowest renal artery.There are no additional images to compare to, so migration cannot be confirmed.H.6.Investigation findings for engineering evaluation: the physician stated that the cause of the distal device migration was aortic neck growth and that the procedure was off-label.There was no infrarenal seal length, and a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) device was used in a snorkel technique to maintain flow to the renal artery.An imaging evaluation was performed to evaluate videos of a cta from the fsa; however, no conclusions were able to be made due to the completeness, format and/or quality of the available images provided for review.An image of the device taken during the explant procedure was also provided, but no product performance conclusions were able to be made based on the image.The findings reported in the description summary were not able to be independently confirmed and the root cause of the reported failure modes could not be determined.H.6.Investigation conclusions: code d1101 added.H.6.Investigation conclusions: code d12 added.According to the gore® excluder® conformable aaa endoprosthesis instructions for use (ifu), the gore® excluder® conformable aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm disease and who have appropriate anatomy including, but not limited to, a proximal aortic neck angulation = 60° and an infrarenal aortic neck treatment diameter range of 16 ¿ 32 mm with a minimum aortic neck length of 15 mm.Key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation (> 60°), short proximal aortic neck (<15 mm), and significant thrombus and/or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.Significant thrombus may be quantified as thrombus = 2 mm in thickness and/or = 25% of the vessel circumference in the intended seal zone of the aortic neck.Irregular calcium and/or plaque may compromise the fixation and sealing of the implantation sites.Additionally, the ifu states that the safety and effectiveness of the gore® excluder® conformable aaa endoprosthesis have not been evaluated in patient populations including, but not limited to, patients with less than 15 mm in length or > 60° angulation of the proximal aortic neck.Ilio-femoral access vessel size and morphology (minimal thrombus, calcium and/or tortuosity) should be compatible with vascular access techniques and accessories of the delivery profile of a 12 fr - 18 fr vascular introducer sheath.Potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, component migration, endoleak, and surgical cut down, bypass or conversion.H.6.Investigation findings for analysis of information provided by user/third party: code c21 updated to code c19.H.6.Investigation conclusions: code d16 updated to code d15.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18637313
• MDR Text Key: 334495770
• Report Number: 3007284313-2024-03027
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2023
• Device Catalogue Number: CXT361414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 02/03/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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: 63 YR
• Patient Sex: Male