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

Model Number	PLL161407
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown which device caused this adverse event.Additional devices included on this report are as follows: catalog #pll161207/ serial # (b)(4) / udi # (b)(4).Concomitant medical products and therapy dates: percocet 10-325 mg, aspirin 81 mg, valium 10 mg, metoprolol tartrate 25 mg, gabapentin 300 mg.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to, endoleak and aneurysm enlargement.
Event or Problem Description
On (b)(6) 2019 the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On (b)(6) 2020 the patient underwent reintervention to treat a distal type i endoleak noted on the iliac extender component located in the patient's left common iliac artery.The endoleak was reportedly feeding the abdominal aortic aneurysm.It was reported that the patient's left common iliac artery was short, and the device did not have sufficient seal distally.It was also reported that, due to the patient's collagen vascular disorder, the diameter of the patient's left common iliac artery had continued to enlarge.The iliac extender component on the patient's left side was extended using a contralateral leg component.The limb was extended into the patient's external iliac artery.An 11x79 gore® viabahn® vbx balloon expandable endoprosthesis was placed in the patient's left internal iliac artery using a kissing technique (partial parallel deployment of two stent grafts within a bifurcated vessel) to preserve the patient's left internal iliac artery.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: 10496104
• Report Number: 3013164176-2020-01036
• Device Sequence Number: 2902685
• Product Code: MIH
• UDI-Device Identifier: 00733132618767
• UDI-Public: 00733132618767
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2020

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: 01/17/2022
• Device Model Number: PLL161407
• Device Catalogue Number: PLL161407
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/04/2020
• 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: 24 YR
• Patient Weight: 59