MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	RLT261418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/20/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Post-implantation computer-tomographic angiographic (cta) images, dated february 5, 2019 were provided to gore for evaluation.The evaluation showed the following: the length from the right renal artery to the proximal circumferential device appears to be approx.2cm ¿ 2.8cm.The diameters within this portion of the aorta appear to range from 25.3mm ¿ 27.8mm.There appears to be lack of proximal device/aortic wall apposition at the proximal aortic curve.Comparison axial images appear to show contrast outside the implanted device pooling in the aneurysmal sac at a level approx.34mm distal to the right renal artery.Cannot confirm or totally rule out a proximal type i endoleak with available imaging.There appears to be an increase in pooling contrast on the delayed series images.There appears to be at least 2 sets of lumbar arteries with contrast that appear to communicate with contrast in the aneurysmal sac.Cannot confirm ante grade or retrograde flow.The limb in the right internal iliac artery appears to be occluded beginning just proximal to the flow divider.The device remains implanted, so no engineering evaluation can be performed.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), users are made aware of the risks associated with type ii endoleaks and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.Additionally, per ifu, adverse events that may occur and / or require intervention include, but are not limited to endoleak and aneurysm enlargement. .
Event or Problem Description
It was reported that on (b)(6) 2015, the patient presented with an abdominal aortic aneurysm and aneurysms in both common iliac arteries that were treated with gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses (ibe).On (b)(6) 2019, a type ii endoleak was identified and successfully treated with polymer sac filling.On (b)(6) 2020, the type ii endoleak was stated to be persistent.The endoleak was treated with embolization with liquid agent.The patient tolerated the procedure.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10633388
• Report Number: 3007284313-2020-00175
• Device Sequence Number: 2438789
• Product Code: MIH
• UDI-Device Identifier: 00733132622474
• UDI-Public: 00733132622474
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2019

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: 11/30/2017
• Device Model Number: RLT261418
• Device Catalogue Number: RLT261418
• Device Lot Number: 13389050
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 74