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

Model Number	PLC161400
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, this patient underwent endovascular treatment for a ruptured left common iliac artery aneurysm (lciaa) and a small abdominal aortic aneurysm (aaa) and was implanted with gore® excluder® aaa endoprostheses.The patient tolerated the procedure with good results and no endoleak visualized.On (b)(6) 2022, the patient underwent follow-up computed tomography angiography and a distal type i endoleak was visualized.The patient underwent reintervention and an additional contralateral leg component was placed to extend coverage and resolved the endoleak.The patient tolerated the procedure, no aneurysm enlargement was reported.
Additional Manufacturer Narrative
Patient medical history includes but is not limited to: back pain, hypertension, tia.Patient medications include but are not limited to: ultram, lovenox, iron supplement, flomax, tylenol.
Additional Manufacturer Narrative
Images were provided to gore and an evaluation showed the following: the proximal main body appears well apposed with no evidence of a type 1a endoleak.There appears to be a couple instances of lumbar arteries communicating with the abdominal aneurism, indicating the presence of type 2 endoleaks.There is contrast visualized outside the l contralateral limb consistent with a type 1b endoleak.There appears to be less than 1cm implanted in the external iliac artery.Lowest renal to l hypogastric length ~ 161mm minimum, 187mm centerline.There appears to be the following: r ipsi: 28.5mm x 14.5mm x 12cm, r extension: not measured, l contralateral limb #1 ~ 14.5mm x 12cm, l contralateral limb #2 ~ 16mm x 9.5cm.Total treatment length, lowest renal to the distal end of the 2nd left contralateral limb ~191mm.
Additional 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: endoleak.

• 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
• Manufacturer (Section G): MEDICAL SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14242605
• Report Number: 3013164176-2022-01361
• Device Sequence Number: 11941761
• Product Code: MIH
• UDI-Device Identifier: 00733132618729
• UDI-Public: 00733132618729
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2022

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: 01/26/2025
• Device Model Number: PLC161400
• Device Catalogue Number: PLC161400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 04/25/2022; 08/18/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 05/04/2022; 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 80 KG