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

Model Number RLT261412

Device Problem Collapse (1099)

Patient Problem Rupture (2208)

Event Date 04/10/2022

Event Type  Death  

Manufacturer Narrative

The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: aneurysm rupture and death.

Event Description

On (b)(6) 2021, this patient underwent endovascular treatment for abaortic abdominal aortic aneurysm and was implanted with gore® excluder® conformable aaa endoprostheses featuring c3® delivery system.The patient tolerated the procedure.On (b)(6) 2022, the patient underwent emergent reintervention to treatment a rupture of the aneurysm.The physician reported the graft at the proximal neck (infrarenal aorta) was collapsed in, like looking at a sliver of the moon on an axial ct.During the procedure angioplasty of the previous graft was performed and then a 26mm gore® excluder® conformable aortic extender component was implanted.The physician suspects the rupture was caused by a proximal type i endoleak caused by some bird beaking which led to enlargement and then rupture.This is unconfirmed due to the rupture.The patient tolerated the procedure.On (b)(6) 2022, it was reported that the patient had expired this same date.A cause of death was unknown but thought to related to the rupture.There were no additional reinterventions performed on the patient and there was no complaint against the aortic extender that was used to treat the rupture.

Manufacturer Narrative

Images were provided to gore for evaluation and showed the following: three timepoints available for evaluation: pre-implantation cta dated (b)(6) 2021, post-implantation cta dated (b)(6) 2022 and post-implantation cta dated (b)(6) 2022.The pre-implantation cta dated (b)(6) 2021 appears to show: there appears to be a 99.6º angle in the abdominal aorta just distal to the first 15mm of abdominal aorta distal to the right renal artery or the ¿proximal landing zone¿.The aortic diameter just distal to the right renal artery appears to be 17.4mm.The aortic diameter between the proximal and distal landing zone appears to be 18.7mm.The aortic diameter 15mm distal to the right renal appears to be 19.4mm.Post-implantation cta imaging dated (b)(6) 2022 appears to show: the length from the right renal artery to the first proximal device marker appears to be ~5.3mm, be centerline.The length from the right renal artery to the proximal circumferential compressed appearing device appears to be 11.7mm, by centerline.There appears to be lack of circumferential device apposition.The proximal circumferential end of the device appears to begin when the abdominal aorta is moving toward the patient¿s right side and continue through the change in direction of the aorta toward the patient¿s left side, thereby, suggesting the finding of compression in the proximal device.There does not appear to be flow through the implanted devices including the device limbs.Contrast can be visualized at the level of the right and left internal iliac arteries and at the distal end of the device limbs extending into the right and left external iliac arteries.Comparison imaging from the 2-post implantation cta scans: additional proximal device markers can be visualized on the (b)(6) 2022 study.3d images show an aortic extender has been implanted between the (b)(6) 2022 and 4/11/2022 scans.The proximal end of the implanted device appears to be fully expanded on the (b)(6) 2022 timepoint.There appears to be a fully expanded trunk portion of device on the (b)(6) 2022 timepoint with flow.Flow appears to be restored throughout the implanted devices on the (b)(6) 2022 cta scan.H6: code 22: adverse events that may occur and/or require intervention include, but are not limited to: occlusion of device or native vessel, h6: correction of code 4315 to code 18: the instructions for use for the gore recommends that the gore® excluder® aaa endoprosthesis diameter be at least 2 mm larger than the aortic inner diameter (10¿21% oversizing) and 1 mm larger than the iliac inner diameter (7¿25% oversizing).The intended aortic diameter of the proximal neck for the trunk-ipsilateral leg endoprosthesis implanted in the patient is 22-23 mm.The safety and effectiveness of the gore® excluder® aaa endoprosthesis have not been evaluated in the following patient populations: patients with > 60° angulation of the proximal aortic neck the gore® excluder® aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease and who have appropriate anatomy as described below: proximal aortic neck angulation = 60°.

• Brand Name: GORE® EXCLUDER® 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14189920
• MDR Text Key: 289908449
• Report Number: 3007284313-2022-01873
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622443
• UDI-Public: 00733132622443
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2023
• Device Model Number: RLT261412
• Device Catalogue Number: RLT261412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2020
• 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): Death
• Patient Age: 77 YR
• Patient Sex: Female