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

Model Number	PLC141000
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #ceb231410a/ serial #(b)(4)/ udi #(b)(4) which is captured in manufacturer report #3013164176-2021-01133.Catalog #plc121200/ serial #(b)(4)/ udi #(b)(4) which is captured in manufacturer report #3013164176-2021-01135.Catalog #pll161007/ serial #(b)(4)/ udi #(b)(4) which is captured in manufacturer report #3013164176-2021-01138.Date of event: as the date of identification of device occlusion is unknown, the date of event has been estimated as the date gore aware: (b)(6) 2021.Concomitant medical products and therapy dates: pravastatin sodium (40mg tablet, oral daily), carvedilol (25mg tablet, oral every 12hours), amlodipine besylate (10mg tablet, oral daily), tamsulosin hcl (0.4mg capsule one oral two times daily).The review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, occlusion of device or native vessel.Furthermore, the gore® excluder® iliac branch endoprosthesis ifu states that the gore® excluder® iliac branch endoprosthesis (ibe) is intended to be used with the gore® excluder® aaa endoprosthesis to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries in patients with a common iliac or aortoiliac aneurysm, who have appropriate anatomy, including: 1.Adequate iliac / femoral access.2.Minimum common iliac diameter of 17 mm at the proximal implantation zone of the ibe.3.External iliac artery treatment diameter range of 6.5 ¿ 25 mm and seal zone length of at least 10 mm.4.Internal iliac artery treatment diameter range of 6.5 ¿ 13.5 mm and seal zone length of at least 10 mm.5.Adequate length from the lowest major renal artery to the internal iliac artery to accommodate the total endoprosthesis length, calculated by adding the minimum lengths of required components, taking into account appropriate overlaps between components.
Event or Problem Description
On (b)(6) 2021, the patient underwent endovascular treatment of arterial occlusive disease using gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses.It was noted that a gore® excluder® iliac branch component (ibc) was placed in the patient's aorta, a gore® excluder® aaa contralateral leg component was placed in the patient's right iliac artery, and a gore® excluder® aaa contralateral leg component and gore® excluder® aaa iliac extender component were placed in the patient's left iliac artery.It was also reported that there was not enough room in the patient's aorta for the ibc device.On an unknown date, device occlusion with no distal blood flow was reported through the devices located in the patient's left iliac artery.The gore representative was made aware of the issue on february 22, 2021.It was reportedly suspected that the device occlusion may have been related to there not being enough room in the patient's aorta for the ibc device.On (b)(6) 2021, a reintervention was performed.It was reported that the contralateral leg component in the patient's right limb was reinforced using a gore® viabahn® vbx balloon expandable endoprosthesis.A femoral-femoral bypass was then performed.The patient tolerated the procedure.

• Brand Name: GORE EXCLUDER 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
• MDR Report Key: 11547708
• Report Number: 3013164176-2021-01139
• Device Sequence Number: 11784170
• Product Code: MIH
• UDI-Device Identifier: 00733132618637
• UDI-Public: 00733132618637
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

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: 08/06/2023
• Device Model Number: PLC141000
• Device Catalogue Number: PLC141000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/22/2021
• 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: 68 YR
• Patient Weight: 87